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Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies


Phase 2
12 Years
64 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Erythroleukemia (M6a), Adult Nasal Type Extranodal NK/T-cell Lymphoma, Adult Pure Erythroid Leukemia (M6b), B-cell Adult Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Burkitt Lymphoma, Childhood Acute Erythroleukemia (M6), Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Minimally Differentiated Myeloid Leukemia (M0), Childhood Acute Monoblastic Leukemia (M5a), Childhood Acute Monocytic Leukemia (M5b), Childhood Acute Myeloid Leukemia in Remission, 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, Chronic Myelomonocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Cutaneous B-cell Non-Hodgkin Lymphoma, de Novo Myelodysplastic Syndromes, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Juvenile Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Nodal Marginal Zone B-cell Lymphoma, Previously Treated Myelodysplastic Syndromes, 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 Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic 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, Refractory Chronic Lymphocytic Leukemia, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Secondary Myelofibrosis, Splenic Marginal Zone Lymphoma, Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia, T-cell Adult Acute Lymphoblastic Leukemia, T-cell Childhood Acute Lymphoblastic Leukemia, T-cell Large Granular Lymphocyte Leukemia, Waldenstrom Macroglobulinemia

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Trial Information

Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies


PRIMARY OBJECTIVES:

1. To establish the day +180 overall survival after a myeloablative unrelated double unit
UCBT in a single institution setting.

SECONDARY OBJECTIVES:

1. To determine the rates of hematologic and immune reconstitution in patients with high
risk hematologic malignancies, who are undergoing myeloablative chemotherapy followed
by infusion of double unit UCBT.

2. To determine the contribution of each umbilical cord unit to immune reconstitution with
a focus on both initial (day +21 BM, and +28 PB) and sustained engraftment (day +100
BM; PB at +14, +21, +28, +35, +42, +60, +100, +180, +1 and 2 years).

3. To determine the probability of overall survival and disease free survival at one and
two years.

4. To describe the incidence of disease recurrence at one and two years in patients post
UCBT.

5. To describe the incidence of acute GVHD and chronic GVHD at 100 days and at one year,
respectively.

6. To determine the incidence of day 100 and 180 treatment related mortality.

7. To determine the incidence of serious infectious complications in the first year after
transplant.

8. To determine the incidence of donor-derived neutrophil and platelet recovery.

9. To determine the incidence of secondary lymphoproliferative diseases following
transplantation with umbilical cord blood.

OUTLINE:

PREPARATIVE REGIMEN: Patients receive oral busulfan every 6 hours on days -8 to -5,
cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV
on days -3 to -1.

TRANSPLANTATION: Patients undergo double-unit umbilical cord blood allogeneic stem cell
transplantation on day 0.

GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and
taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally every 8
hours on days -3 to 45. After completion of study treatment, patients are followed
periodically.


Inclusion Criteria:



- Patients will be diagnosed with one of the following hematological malignancies:
acute myelogenous leukemia (AML), acute lymphoblastic leukemia, non-Hodgkin's
lymphoma, myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), and
myeloproliferative and lymphoproliferative disorders

- AML--First remission (CR1) with high risk features including a known prior diagnosis
of myelodysplasia (MDS); therapy related AML; white cell count at presentation >
100,000; presence of extramedullary leukemia at diagnosis; unfavorable AML subtype
(M0, M5-M7); poor cytogenetic markers (abnormalities of chromosome 5, 7 or 8, 11q23,
Philadelphia chromosome, complex karyotype)

- AML--Second remission (CR2) or subsequent remission

- AML--Relapse/Persistent Disease with < 20% bone marrow blasts

- ALL--First remission (CR1) at high risk for relapse as defined by: B cell ALL white
blood cell count (WBC) at presentation > 30,000 (T cell ALL WBC > 100,000); presence
of high-risk cytogenetic abnormality such as t(9;22), t(1;19), t(4;11) or other MLL
rearrangements (11q23), t(8;14)

- ALL--Second remission (CR2) or subsequent remission

- ALL--Relapse/Persistent Disease with < 20% bone marrow blasts

- Non-Hodgkin Lymphoma--Induction failure or relapse and sensitive to most recent
chemotherapy

- MDS--Low or Intermediate-1 International Prognostic Scoring System (IPSS) score with:
life-threatening cytopenia(s); and/or red cell or platelet transfusion dependence

- MDS--ANC < 500, recurrent infections, PRBC transfusions > 2 units/month, poor risk
cytogenetics, platelet transfusion dependence

- MDS--Intermediate-2 or High IPSS score

- CML--Chronic phase I (CP1) and resistant to or intolerant of tyrosine kinase
inhibitors (i.e. imatinib, dasatinib, etc.)

- CML--CP2 or subsequent chronic phase, including chronic phase achieved after
induction therapy for blast crisis

- Myeloproliferative and lymphoproliferative disorders--eligibility to be determined by
a consensus of the physicians on the Case Comprehensive Cancer Center
Leukemia/Lymphoma Multidisciplinary Committee

- Myeloproliferative and lymphoproliferative disorders--must have evidence of disease
acceleration to be a candidate for umbilical cord blood transplant;
myeloproliferative disorders eligible for transplant include chronic myelomonocytic
leukemia (CMML) with high IPSS score and myelofibrosis

- Myeloproliferative and lymphoproliferative disorders--potential lymphoproliferative
disorders eligible for transplant include chronic lymphocytic leukemia,
prolymphocytic leukemia, and large granular lymphocytic leukemia

- Good performance status: Karnofsky >= 70 % or ECOG 0-1

- Calculated creatinine clearance >= 60 mL/min, or measured creatinine clearance >= 60
mL/min (by 24-hour urine collection) if creatinine >= 1.5 or history of renal
dysfunction

- Hepatic Transaminases < 4 x upper limit normal (ULN); total bilirubin < 2.5 mg/dL,
unless the patient has a history of benign congenital hyperbilirubinemia (Gilbert's
syndrome)

- Normal cardiac function by echocardiogram or radionuclide scan, (left ventricular
ejection fraction > 45%); if the left ventricular ejection fraction is between
40-50%, clearance by an adult cardiologist is required

- Pulmonary function tests demonstrating FEV1 > 60% of predicted for age

- Adults must have a DLCOva > 60% normal

- For patients unable to complete pulmonary function tests clearance by an adult
pulmonologist is required

- Patients will be eligible for the clinical trial under the following conditions: they
do NOT have an HLA-A/B/DR B1 identical RELATED bone marrow donor; they do NOT have a
6/6 HLA-identical matched unrelated adult donor; OR a matched related donor
transplant is not in the best interest of the patient (i.e., patient's condition
precludes waiting on the donor, too much time to prepare the donor, the donor is
ineligible due to medical reasons, or in the case of high risk disease a related
donor is not appropriated (syngeneic transplant); the decision must be agreed upon by
the consensus of physicians on the Case Comprehensive Cancer Center Leukemia/Lymphoma
Multidisciplinary Committee; OR their condition precludes waiting to search and find
a donor in the National Marrow Donor Registry

Exclusion Criteria:

- Female patients who are pregnant or breast-feeding

- HIV or HTLV-1 positivity

- Any leukemia with a morphologic relapse or persistent disease in the BM with >= 20%
blasts (cytogenetic relapse without morphologic evidence of relapse, or cytogenetic
persistent disease is acceptable)

- Active extramedullary leukemia, including CNS disease

- Prior hematopoietic stem cell transplant (autologous or allogeneic)

- Uncontrolled infection

- Patient has an identical related bone marrow donor or a 6/6 HLA-identical matched
unrelated donor

- Any patient who is unable to provide informed consent or comply with the requirements
of the protocol

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

On day +180

Safety Issue:

No

Principal Investigator

Brenda Cooper, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE3Z07

NCT ID:

NCT01093586

Start Date:

March 2009

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
  • Adult Acute Lymphoblastic Leukemia in Remission
  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Erythroleukemia (M6a)
  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Adult Pure Erythroid Leukemia (M6b)
  • B-cell Adult Acute Lymphoblastic Leukemia
  • B-cell Childhood Acute Lymphoblastic Leukemia
  • Blastic Phase Chronic Myelogenous Leukemia
  • Burkitt Lymphoma
  • Childhood Acute Erythroleukemia (M6)
  • Childhood Acute Lymphoblastic Leukemia in Remission
  • Childhood Acute Megakaryocytic Leukemia (M7)
  • Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Childhood Acute Monoblastic Leukemia (M5a)
  • Childhood Acute Monocytic Leukemia (M5b)
  • Childhood Acute Myeloid Leukemia in Remission
  • 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
  • Chronic Myelomonocytic Leukemia
  • Chronic Phase Chronic Myelogenous Leukemia
  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • de Novo Myelodysplastic Syndromes
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Juvenile Myelomonocytic Leukemia
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Nodal Marginal Zone B-cell Lymphoma
  • Previously Treated Myelodysplastic Syndromes
  • 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 Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic 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
  • Refractory Chronic Lymphocytic Leukemia
  • Relapsing Chronic Myelogenous Leukemia
  • Secondary Acute Myeloid Leukemia
  • Secondary Myelodysplastic Syndromes
  • Secondary Myelofibrosis
  • Splenic Marginal Zone Lymphoma
  • Stage I Chronic Lymphocytic Leukemia
  • Stage II Chronic Lymphocytic Leukemia
  • Stage III Chronic Lymphocytic Leukemia
  • Stage IV Chronic Lymphocytic Leukemia
  • T-cell Adult Acute Lymphoblastic Leukemia
  • T-cell Childhood Acute Lymphoblastic Leukemia
  • T-cell Large Granular Lymphocyte Leukemia
  • Waldenström Macroglobulinemia
  • Congenital Abnormalities
  • Primary Myelofibrosis
  • Blast Crisis
  • Burkitt Lymphoma
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Prolymphocytic
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Waldenstrom Macroglobulinemia
  • Mycoses
  • Mycosis Fungoides
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Myeloproliferative Disorders
  • Sezary Syndrome
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, Mantle-Cell
  • Leukemia, Myelomonocytic, Juvenile
  • Hematologic Neoplasms
  • Myelodysplastic-Myeloproliferative Diseases
  • Leukemia, Large Granular Lymphocytic

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065