Donor Statin Treatment for Prevention of Severe Acute GVHD After Nonmyeloablative Hematopoietic Cell Transplantation
Phase 2
N/A
75 Years
N/A
75 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia/Transient Myeloproliferative Disorder, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Childhood Burkitt Lymphoma, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Contiguous Stage II Adult Burkitt Lymphoma, Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma, Contiguous Stage II Adult Lymphoblastic Lymphoma, Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Grade 3 Follicular Lymphoma, Contiguous Stage II Mantle Cell Lymphoma, Contiguous Stage II Marginal Zone Lymphoma, Contiguous Stage II Small Lymphocytic Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, de Novo Myelodysplastic Syndromes, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Adult Burkitt Lymphoma, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma, Noncontiguous Stage II Adult Lymphoblastic Lymphoma, Noncontiguous Stage II Grade 1 Follicular Lymphoma, Noncontiguous Stage II Grade 2 Follicular Lymphoma, Noncontiguous Stage II Grade 3 Follicular Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell Lymphoma, Previously Treated Myelodysplastic Syndromes, Progressive Hairy Cell Leukemia, Initial Treatment, Prolymphocytic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Recurrent/Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Refractory Multiple Myeloma, Relapsing Chronic Myelogenous Leukemia, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Stage I Adult Burkitt Lymphoma, Stage I Adult Diffuse Large Cell Lymphoma, Stage I Adult Diffuse Mixed Cell Lymphoma, Stage I Adult Diffuse Small Cleaved Cell Lymphoma, Stage I Adult Immunoblastic Large Cell Lymphoma, Stage I Adult Lymphoblastic Lymphoma, Stage I Adult T-cell Leukemia/Lymphoma, Stage I Childhood Anaplastic Large Cell Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Lymphoblastic Lymphoma, Stage I Childhood Small Noncleaved Cell Lymphoma, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Grade 1 Follicular Lymphoma, Stage I Grade 2 Follicular Lymphoma, Stage I Grade 3 Follicular Lymphoma, Stage I Mantle Cell Lymphoma, Stage I Marginal Zone Lymphoma, Stage I Mycosis Fungoides/Sezary Syndrome, Stage I Small Lymphocytic Lymphoma, Stage II Adult T-cell Leukemia/Lymphoma, Stage II Childhood Anaplastic Large Cell Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Lymphoblastic Lymphoma, Stage II Childhood Small Noncleaved Cell Lymphoma, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Mycosis Fungoides/Sezary Syndrome, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Mixed Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Immunoblastic Large Cell Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Adult T-cell Leukemia/Lymphoma, Stage III Childhood Anaplastic Large Cell Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Childhood Lymphoblastic Lymphoma, Stage III Childhood Small Noncleaved Cell Lymphoma, Stage III Cutaneous T-cell Non-Hodgkin Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Mycosis Fungoides/Sezary Syndrome, Stage III Small Lymphocytic Lymphoma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Hodgkin Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Adult T-cell Leukemia/Lymphoma, Stage IV Childhood Anaplastic Large Cell Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Childhood Lymphoblastic Lymphoma, Stage IV Childhood Small Noncleaved Cell Lymphoma, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Mycosis Fungoides/Sezary Syndrome, Stage IV Small Lymphocytic Lymphoma, T-cell Large Granular Lymphocyte Leukemia, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia, Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies, Waldenström Macroglobulinemia
Both
Acute Myeloid Leukemia/Transient Myeloproliferative Disorder, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Childhood Burkitt Lymphoma, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Contiguous Stage II Adult Burkitt Lymphoma, Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma, Contiguous Stage II Adult Lymphoblastic Lymphoma, Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Grade 3 Follicular Lymphoma, Contiguous Stage II Mantle Cell Lymphoma, Contiguous Stage II Marginal Zone Lymphoma, Contiguous Stage II Small Lymphocytic Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, de Novo Myelodysplastic Syndromes, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Adult Burkitt Lymphoma, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma, Noncontiguous Stage II Adult Lymphoblastic Lymphoma, Noncontiguous Stage II Grade 1 Follicular Lymphoma, Noncontiguous Stage II Grade 2 Follicular Lymphoma, Noncontiguous Stage II Grade 3 Follicular Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell Lymphoma, Previously Treated Myelodysplastic Syndromes, Progressive Hairy Cell Leukemia, Initial Treatment, Prolymphocytic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Recurrent/Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Refractory Multiple Myeloma, Relapsing Chronic Myelogenous Leukemia, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Stage I Adult Burkitt Lymphoma, Stage I Adult Diffuse Large Cell Lymphoma, Stage I Adult Diffuse Mixed Cell Lymphoma, Stage I Adult Diffuse Small Cleaved Cell Lymphoma, Stage I Adult Immunoblastic Large Cell Lymphoma, Stage I Adult Lymphoblastic Lymphoma, Stage I Adult T-cell Leukemia/Lymphoma, Stage I Childhood Anaplastic Large Cell Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Lymphoblastic Lymphoma, Stage I Childhood Small Noncleaved Cell Lymphoma, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Grade 1 Follicular Lymphoma, Stage I Grade 2 Follicular Lymphoma, Stage I Grade 3 Follicular Lymphoma, Stage I Mantle Cell Lymphoma, Stage I Marginal Zone Lymphoma, Stage I Mycosis Fungoides/Sezary Syndrome, Stage I Small Lymphocytic Lymphoma, Stage II Adult T-cell Leukemia/Lymphoma, Stage II Childhood Anaplastic Large Cell Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Lymphoblastic Lymphoma, Stage II Childhood Small Noncleaved Cell Lymphoma, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Mycosis Fungoides/Sezary Syndrome, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Mixed Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Immunoblastic Large Cell Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Adult T-cell Leukemia/Lymphoma, Stage III Childhood Anaplastic Large Cell Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Childhood Lymphoblastic Lymphoma, Stage III Childhood Small Noncleaved Cell Lymphoma, Stage III Cutaneous T-cell Non-Hodgkin Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Mycosis Fungoides/Sezary Syndrome, Stage III Small Lymphocytic Lymphoma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Hodgkin Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Adult T-cell Leukemia/Lymphoma, Stage IV Childhood Anaplastic Large Cell Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Childhood Lymphoblastic Lymphoma, Stage IV Childhood Small Noncleaved Cell Lymphoma, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Mycosis Fungoides/Sezary Syndrome, Stage IV Small Lymphocytic Lymphoma, T-cell Large Granular Lymphocyte Leukemia, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia, Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies, Waldenström Macroglobulinemia
Trial Information
Donor Statin Treatment for Prevention of Severe Acute GVHD After Nonmyeloablative Hematopoietic Cell Transplantation
PRIMARY OBJECTIVES:
I. To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute
GVHD.
SECONDARY OBJECTIVES:
I. To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible,
tolerable and safe.
OUTLINE:
DONOR: Donors receive atorvastatin orally (PO) once daily (QD) beginning on day -14 and
continuing until the last day of stem cell collection.
NONMYELOABLATIVE PREPARATIVE REGIMEN: If the patient is enrolled on an investigational
nonmyeloablative HCT protocol with postgrafting CSP that does not use acute GVHD as it
primary endpoint, the preparative regimen and immunosuppression after transplant will be
according to respective protocol (Protocol 2546 serves as adjunct protocol)
If the patient is not enrolled on an investigational nonmyeloablative HCT protocol, Protocol
2546 serves as an independent primary treatment protocol. The preparative regimen and
immunosuppression after transplant is as follows:
Patients receive fludarabine intravenously (IV) on days -4 to -2 and undergo low-dose total
body irradiation (TBI) on day 0.
TRANSPLANT: Patients undergo donor PBSC transplant on day 0.
POST-GRAFTING IMMUNOSUPPRESSION: Patients receive cyclosporine (CSP) PO twice daily (BID) on
days -3 to +56 with taper to day +180. Patients also receive mycophenolate mofetil (MMF) PO
BID or IV every 12 hours on days 0-27.
After completion of study treatment, patients are followed up at 1 year and then annually
thereafter.
Inclusion Criteria:
- Availability of human leukocyte antigen (HLA)-identical sibling donor
- Transplantation with PBSC
- CSP-based postgrafting immunosuppression
- Willingness to give informed consent
- Patient is enrolled on an investigational nonmyeloablative hematopoietic cell
transplant (HCT) protocol or a nonmyeloablative treatment plan with postgrafting CSP
that does not use acute GVHD as its primary endpoint (protocol 2546 serves as adjunct
protocol)
- OR patient is not enrolled on an investigational nonmyeloablative HCT protocol, in
which case protocol 2546 serves as an independent primary treatment protocol and the
patient must meet the following inclusion and exclusion criteria:
- Patients must have a hematologic malignancy treatable by nonmyeloablative HCT; the
following diseases will be permitted although other diagnoses can be considered if
approved by PCC and the principal investigator:
- Aggressive non-Hodgkin lymphomas (NHL) and other histologies such as diffuse large
B-cell NHL - not eligible for autologous HCT, not eligible for high-dose allogeneic
HCT, or after failed autologous HCT
- Mantle-cell NHL - may be treated in first complete remission (CR); (diagnostic lumbar
puncture [LP] required pre-transplant)
- Low grade NHL - with < 6 month duration of CR between courses of conventional therapy
- Chronic lymphocytic leukemia (CLL) - must have either:
- Failed to meet National Cancer Institute (NCI) Working Group criteria for
complete or partial response after therapy with a regimen containing fludarabine
phosphate (FLU) (or another nucleoside analog) or experience disease relapse
within 12 months after completing therapy with a regimen containing FLU (or
another nucleoside analog)
- Failed FLU-cyclophosphamide (CY)-Rituximab (FCR) combination chemotherapy at any
time point; or
- Have "17p deletion" cytogenetic abnormality; patients should have received
induction chemotherapy but could be transplanted in 1st CR
- Patients with a diagnosis of CLL (or small lymphocytic lymphoma) that progresses
to prolymphocytic leukemia (PLL); or
- Patients with T-cell CLL or PLL
- Hodgkin lymphoma - must have received and failed frontline therapy
- Multiple myeloma - must have received prior chemotherapy; consolidation of
chemotherapy by autografting prior to nonmyeloablative HCT is permitted
- Acute myeloid leukemia (AML) - must have < 5% marrow blasts at the time of transplant
- Acute lymphocytic leukemia (ALL) - must have < 5% marrow blasts at the time of
transplant
- Chronic myeloid leukemia (CML) - Patients will be accepted if they are beyond CP1 and
if they have received previous myelosuppressive chemotherapy or HCT, and have < 5%
marrow blasts at time of transplant
- Myelodysplasia (MDS)/ myeloproliferative syndrome (MPS) - Patients must have < 5%
marrow blasts at time of transplant
- Waldenstrom's macroglobulinemia - must have failed 2 courses of therapy
- Patients < 12 years of age must be approved by the principal investigator and by a
relevant patient review committee, such as the Fred Hutchinson Cancer Research Center
(FHCRC) Patient Care Conference (PCC)
- Patients must have either relapsed after previous high-dose chemotherapy and
autologous or allogeneic HCT, or else be ineligible for such an approach due to age,
failure to mobilize sufficient hematopoietic stem cells, medical comorbidities, or
patient refusal
- Patients who refuse to be treated on a conventional autologous or allogeneic HCT
protocol
- DONOR: Age >= 18 years
- DONOR: HLA genotypically identical sibling
- DONOR: Willingness to give informed consent
Exclusion Criteria:
- IF PROTOCOL 2546 SERVES AS AN ADJUNCT PROTOCOL, THE PATIENT ONLY NEEDS TO MEET
EXCLUSION CRITERIA 1 THROUGH 3 SINCE CRITERIA 4-12 ARE ADDRESSED IN THE INDEPENDENT
PRIMARY TREATMENT PROTOCOL
- Myeloablative preparative regimen
- Participation in an investigational study that has acute GVHD as the primary endpoint
- The allogeneic PBSC donor has a contraindication to statin treatment
- Patients eligible for and willing to receive potentially curative high-dose
chemotherapy and autologous HCT
- Cardiac ejection fraction < 30% on multi gated acquisition scan (MUGA) scan or
cardiac echo or active symptomatic coronary artery disease; patients with cardiac
disease should be evaluated with appropriate cardiac studies and/or cardiology
consultation as clinically indicated
- Diffusion capacity of carbon monoxide (DLCO) corrected < 40% of predicted, total lung
capacity (TLC) < 30% of predicted, forced expiratory volume in one second (FEV1) <
30% of predicted, or receiving continuous supplementary oxygen
- Patients with clinical or laboratory evidence of liver disease should be evaluated in
conjunction with the gastrointestinal (GI) consult service for the cause of the liver
disease, its clinical severity, and the degree of portal hypertension; patients will
be excluded if they are found to have fulminant liver failure, cirrhosis of the liver
with evidence of portal hypertension, bridging fibrosis, alcoholic hepatitis,
esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy,
refractory ascites related to portal hypertension, bacterial or fungal liver abscess,
chronic viral hepatitis with total serum bilirubin > 3mg/dl, or actively symptomatic
biliary disease
- Patients with renal failure are eligible; however, patients with pre-existing renal
insufficiency will likely have further compromise in renal function and may require
dialysis
- Patients who are seropositive for human immunodeficiency virus (HIV)
- Women who are pregnant or breast-feeding
- Fertile men or women unwilling to use contraception during HCT and for 12 months
afterward
- Patients with active non-hematological malignancies (except for localized
non-melanoma skin malignancies); patients with clinically indolent non-hematologic
malignancies not requiring active treatment may be eligible, but must be approved by
the relevant patient care committee (e.g. FHCRC PCC) and the principal investigator
- Karnofsky score < 60 for adult patients
- Lansky-Play Performance Score < 50 for pediatric patients
- Patients with fungal pneumonia with radiological progression after receipt of
amphotericin formulation or mold-active azoles for greater than 1 month
- DONOR: Age < 18 years
- DONOR: Active liver disease (alanine aminotransferase [ALT] or aspartate
aminotransferase [AST] levels > 2 times the upper limit of normal [ULN])
- DONOR: History of myopathy
- DONOR: Hypersensitivity to atorvastatin
- DONOR: Pregnancy
- DONOR: Nursing mother
- DONOR: Current serious systemic illness
- DONOR: Concurrent treatment with strong inhibitors of hepatic CYP 3A4 (i.e.
clarithromycin, erythromycin, protease inhibitors, azole antifungals)
- DONOR: Current use of statin drug
- DONOR: Failure to meet FHCRC criteria for stem cell donation
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Proportion of patients who develop grade 3-4 acute GVHD after transplant
Outcome Description:
The cumulative incidence of this endpoint in patients prepared with nonmyeloablative conditioning regimens after HCT from HLA-matched related donors, and with CSP-based immunosuppression is approximately 9%. A reduction in the cumulative incidence of acute GVHD from 9% to < 2% would represent a reasonable goal after nonmyeloablative HCT and constitute study success.
Outcome Time Frame:
Up to day 100
Safety Issue:
No
Principal Investigator
Marco Mielcarek
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Authority:
United States: Federal Government
Study ID:
2546.00
NCT ID:
NCT01527045
Start Date:
September 2012
Completion Date:
Related Keywords:
- Acute Myeloid Leukemia/Transient Myeloproliferative Disorder
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Childhood Burkitt Lymphoma
- Childhood Chronic Myelogenous Leukemia
- Childhood Diffuse Large Cell Lymphoma
- Childhood Immunoblastic Large Cell Lymphoma
- Childhood Myelodysplastic Syndromes
- Childhood Nasal Type Extranodal NK/T-cell Lymphoma
- Contiguous Stage II Adult Burkitt Lymphoma
- Contiguous Stage II Adult Diffuse Large Cell Lymphoma
- Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma
- Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
- Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma
- Contiguous Stage II Adult Lymphoblastic Lymphoma
- Contiguous Stage II Grade 1 Follicular Lymphoma
- Contiguous Stage II Grade 2 Follicular Lymphoma
- Contiguous Stage II Grade 3 Follicular Lymphoma
- Contiguous Stage II Mantle Cell Lymphoma
- Contiguous Stage II Marginal Zone Lymphoma
- Contiguous Stage II Small Lymphocytic Lymphoma
- Cutaneous B-cell Non-Hodgkin Lymphoma
- de Novo Myelodysplastic Syndromes
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Hepatosplenic T-cell Lymphoma
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Nodal Marginal Zone B-cell Lymphoma
- Noncontiguous Stage II Adult Burkitt Lymphoma
- Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
- Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
- Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
- Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
- Noncontiguous Stage II Adult Lymphoblastic Lymphoma
- Noncontiguous Stage II Grade 1 Follicular Lymphoma
- Noncontiguous Stage II Grade 2 Follicular Lymphoma
- Noncontiguous Stage II Grade 3 Follicular Lymphoma
- Noncontiguous Stage II Mantle Cell Lymphoma
- Noncontiguous Stage II Marginal Zone Lymphoma
- Noncontiguous Stage II Small Lymphocytic Lymphoma
- Noncutaneous Extranodal Lymphoma
- Peripheral T-cell Lymphoma
- Previously Treated Myelodysplastic Syndromes
- Progressive Hairy Cell Leukemia, Initial Treatment
- Prolymphocytic Leukemia
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Recurrent Childhood Anaplastic Large Cell Lymphoma
- Recurrent Childhood Grade III Lymphomatoid Granulomatosis
- Recurrent Childhood Large Cell Lymphoma
- Recurrent Childhood Lymphoblastic Lymphoma
- Recurrent Childhood Small Noncleaved Cell Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Recurrent Small Lymphocytic Lymphoma
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Refractory Hairy Cell Leukemia
- Refractory Multiple Myeloma
- Relapsing Chronic Myelogenous Leukemia
- Small Intestine Lymphoma
- Splenic Marginal Zone Lymphoma
- Stage I Adult Burkitt Lymphoma
- Stage I Adult Diffuse Large Cell Lymphoma
- Stage I Adult Diffuse Mixed Cell Lymphoma
- Stage I Adult Diffuse Small Cleaved Cell Lymphoma
- Stage I Adult Immunoblastic Large Cell Lymphoma
- Stage I Adult Lymphoblastic Lymphoma
- Stage I Adult T-cell Leukemia/Lymphoma
- Stage I Childhood Anaplastic Large Cell Lymphoma
- Stage I Childhood Large Cell Lymphoma
- Stage I Childhood Lymphoblastic Lymphoma
- Stage I Childhood Small Noncleaved Cell Lymphoma
- Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage I Grade 1 Follicular Lymphoma
- Stage I Grade 2 Follicular Lymphoma
- Stage I Grade 3 Follicular Lymphoma
- Stage I Mantle Cell Lymphoma
- Stage I Marginal Zone Lymphoma
- Stage I Mycosis Fungoides/Sezary Syndrome
- Stage I Small Lymphocytic Lymphoma
- Stage II Adult T-cell Leukemia/Lymphoma
- Stage II Childhood Anaplastic Large Cell Lymphoma
- Stage II Childhood Large Cell Lymphoma
- Stage II Childhood Lymphoblastic Lymphoma
- Stage II Childhood Small Noncleaved Cell Lymphoma
- Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage II Mycosis Fungoides/Sezary Syndrome
- Stage III Adult Burkitt Lymphoma
- Stage III Adult Diffuse Large Cell Lymphoma
- Stage III Adult Diffuse Mixed Cell Lymphoma
- Stage III Adult Diffuse Small Cleaved Cell Lymphoma
- Stage III Adult Immunoblastic Large Cell Lymphoma
- Stage III Adult Lymphoblastic Lymphoma
- Stage III Adult T-cell Leukemia/Lymphoma
- Stage III Childhood Anaplastic Large Cell Lymphoma
- Stage III Childhood Large Cell Lymphoma
- Stage III Childhood Lymphoblastic Lymphoma
- Stage III Childhood Small Noncleaved Cell Lymphoma
- Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage III Grade 1 Follicular Lymphoma
- Stage III Grade 2 Follicular Lymphoma
- Stage III Grade 3 Follicular Lymphoma
- Stage III Mantle Cell Lymphoma
- Stage III Marginal Zone Lymphoma
- Stage III Mycosis Fungoides/Sezary Syndrome
- Stage III Small Lymphocytic Lymphoma
- Stage IV Adult Burkitt Lymphoma
- Stage IV Adult Diffuse Large Cell Lymphoma
- Stage IV Adult Diffuse Mixed Cell Lymphoma
- Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
- Stage IV Adult Hodgkin Lymphoma
- Stage IV Adult Immunoblastic Large Cell Lymphoma
- Stage IV Adult Lymphoblastic Lymphoma
- Stage IV Adult T-cell Leukemia/Lymphoma
- Stage IV Childhood Anaplastic Large Cell Lymphoma
- Stage IV Childhood Large Cell Lymphoma
- Stage IV Childhood Lymphoblastic Lymphoma
- Stage IV Childhood Small Noncleaved Cell Lymphoma
- Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage IV Grade 1 Follicular Lymphoma
- Stage IV Grade 2 Follicular Lymphoma
- Stage IV Grade 3 Follicular Lymphoma
- Stage IV Mantle Cell Lymphoma
- Stage IV Marginal Zone Lymphoma
- Stage IV Mycosis Fungoides/Sezary Syndrome
- Stage IV Small Lymphocytic Lymphoma
- T-cell Large Granular Lymphocyte Leukemia
- Untreated Adult Acute Lymphoblastic Leukemia
- Untreated Adult Acute Myeloid Leukemia
- Untreated Childhood Acute Lymphoblastic Leukemia
- Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
- Waldenström Macroglobulinemia
- Congenital Abnormalities
- Burkitt Lymphoma
- Neoplasms
- Hodgkin Disease
- Immunoblastic Lymphadenopathy
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Hairy Cell
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Prolymphocytic
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Lymphomatoid Granulomatosis
- Waldenstrom Macroglobulinemia
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Mycoses
- Mycosis Fungoides
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Sezary Syndrome
- Lymphoma, B-Cell
- Lymphoma, Large-Cell, Immunoblastic
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
- Lymphoma, T-Cell, Peripheral
- Lymphoma, Large-Cell, Anaplastic
- Lymphoma, B-Cell, Marginal Zone
- Lymphoma, Extranodal NK-T-Cell
- Lymphoma, Mantle-Cell
- Myelodysplastic-Myeloproliferative Diseases
- Leukemia, Large Granular Lymphocytic
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
