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Induction Of Mixed Hematopoietic Chimerism In Older Patients With B-Cell Malignancies and in Selected Other Diseases, Using Low Dose TBI , PBSC Infusion And Post-Transplant Immunosuppression With Cyclosporine And Mycophenolate Mofetil to be Followed by Donor Lymphocyte Infusion: A Pilot Study.


N/A
50 Years
65 Years
Open (Enrolling)
Both
Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell Lymphoma, 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 Adult T-cell Leukemia/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, Refractory Hairy Cell Leukemia, Refractory Multiple Myeloma, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Stage II Multiple Myeloma, Stage III Multiple Myeloma, T-cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Waldenström Macroglobulinemia

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Trial Information

Induction Of Mixed Hematopoietic Chimerism In Older Patients With B-Cell Malignancies and in Selected Other Diseases, Using Low Dose TBI , PBSC Infusion And Post-Transplant Immunosuppression With Cyclosporine And Mycophenolate Mofetil to be Followed by Donor Lymphocyte Infusion: A Pilot Study.


PRIMARY OBJECTIVES:

I. To determine whether mixed hematopoietic chimerism can be safely established using a
non-myeloablative conditioning regimen in patients with non-Hodgkin lymphoma (NHL), chronic
lymphocytic leukemia (CLL) and multiple myeloma.

II. To determine whether mixed chimerism, established with non- myeloablative conditioning
regimens, can be safely converted to full donor hematopoietic chimerism by infusions of
donor lymphocytes (DLI).

OUTLINE:

CYTOREDUCTION: If necessary, patients with advanced malignancies undergo cytoreductive
chemotherapy to reduce tumor size at discretion of primary physician and study
investigators.

CONDITIONING REGIMEN: Patients undergo low-dose total-body irradiation followed by
allogeneic peripheral blood stem cell (PBSC) transplant on day 0.

IMMUNOSUPPRESSION: Patients receive cyclosporine intravenously (IV) twice daily (BID) on
days -1 to 0 and then orally (PO) BID on days 1-35 with taper to day 56. Patients also
receive mycophenolate mofetil PO BID on days 0-27.

POST-TRANSPLANT DLI: Patients with mixed chimerism on day 56 and no evidence of
graft-vs-host disease (GVHD) undergo DLI over 30 minutes on day 65 and may receive up to 3
additional infusions in the absence of GVHD and disease progression or persistence. Patients
who have not achieved mixed chimerism at day 56 undergo DLI if complete response is not
obtained after a 2 month monitoring period.

After completion of study treatment, patients are followed up at 4, 6, 12, 18, and 24 months
and then annually thereafter.


Inclusion Criteria:



- Patients aged > 49 years and < 66 years with NHL, CLL and multiple myeloma who are
not eligible for autologous transplantation or have failed prior autologous
transplantation; patients with NHL and CLL must have failed prior therapy with an
alkylating agent and/or fludarabine; patients with multiple myeloma must have stage
II or III disease and received prior chemotherapy

- Patients < 50 years of age with NHL, CLL and multiple myeloma at high risk of regimen
related toxicity through prior autologous transplant or through pre-existing chronic
disease affecting kidneys, liver, lungs, and heart will be considered on a case by
case basis and presented to professional clinical counselor (PCC)

- Patients < 66 years of age with other diseases treatable by allogeneic BMT whom
through pre-existing chronic disease affecting kidneys, liver, lungs, and heart are
considered to be at high risk for regimen related toxicity using standard high dose
regimens; autografting must also be contraindicated in these patients and they must
be approved for this protocol by both PCC and by the principle investigator; the
following diseases are the likely candidates but other less common diseases may be
considered and approved by PCC:

- Myelodysplastic syndromes

- Myeloproliferative syndromes

- Acute leukemia in remission

- Chronic myelogenous leukemia (CML) in 2nd chronic phase

- Hodgkin's disease

- Selected patients with any of the above diagnosis who are (a) older than 65 years and
< 75 years with a Karnofsky score > 70 and who, apart from age, fulfill eligibility
criteria, or (b) < 66 years but ineligible solely because of renal dysfunction; these
patients must be approved for transplant by both PCC and the principal investigator

- DONOR: Human leukocyte antigen (HLA) genotypically identical sibling

- DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis

- DONOR: Donor must have adequate veins for leukapheresis or agree to placement of
central venous catheter (femoral, subclavian)

- DONOR: Age < 75

Exclusion Criteria:

- Eligible for autologous transplantation

- Patients with rapidly progressive high grade NHL

- History of central nervous system (CNS) involvement with disease

- Fertile men or women unwilling to use contraceptive techniques during and for 12
months following treatment

- Females who are pregnant

- Patients with a creatinine clearance < 50 ml/min

- Cardiac ejection fraction < 40% or cardiac failure requiring therapy

- Severe defects in pulmonary function testing (defects are currently categorized as
mild, moderate and severe) as defined by the pulmonary consultant, or receiving
supplementary continuous oxygen

- Total bilirubin > 2 x the upper limit of normal

- Serum glutamic pyruvate transaminase (SGPT) and serum glutamic oxaloacetic
transaminase (SGOT) 4 x the upper limit of normal

- Karnofsky score < 50

- Patients with poorly controlled hypertension

- DONOR: Identical twin

- DONOR: Age less than 12 years

- DONOR: Pregnancy

- DONOR: Infection with human immunodeficiency virus (HIV)

- DONOR: Inability to achieve adequate venous access

- DONOR: Known allergy to G-CSF

- DONOR: Current serious systemic illness

- DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) criteria for
donation as described in the Standard Practice Guidelines

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of GVHD, myelosuppression, and infections

Outcome Description:

At the conclusion of the study, all unexpected toxicities will be summarized and reported.

Outcome Time Frame:

Up to 5 years

Safety Issue:

Yes

Principal Investigator

David Maloney

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

1225.00

NCT ID:

NCT00003196

Start Date:

September 1997

Completion Date:

Related Keywords:

  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Hepatosplenic T-cell Lymphoma
  • Intraocular Lymphoma
  • Nodal Marginal Zone B-cell Lymphoma
  • Noncutaneous Extranodal Lymphoma
  • Peripheral T-cell Lymphoma
  • 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 Adult T-cell Leukemia/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
  • Refractory Hairy Cell Leukemia
  • Refractory Multiple Myeloma
  • Small Intestine Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • T-cell Large Granular Lymphocyte Leukemia
  • Testicular Lymphoma
  • Waldenström Macroglobulinemia
  • Burkitt Lymphoma
  • Immunoblastic Lymphadenopathy
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Hairy Cell
  • Leukemia, Lymphoid
  • 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
  • Sezary Syndrome
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • 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
  • Leukemia, Large Granular Lymphocytic

Name

Location

Stanford UniversityStanford, California  94305
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
City of Hope Medical CenterDuarte, California  91010