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Investigator(s):
Michael Bishop, M.D. Principal Investigator Phone: 301-435-2764 mbishop@mail.nih.gov
Referral Contact(s):
Bazetta (Zetta) Blacklock, R.N., B.S., B.S.N. Transplant Coordinator Phone: 301-594-2056 Fax: 301-435-6830 bblacklock@mail.nih.gov

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Primary Eligibility:

• Confirmed diagnosis of Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, chronic myelogenous leukemia, chronic lymphocytic leukemia, acute lymphoblastic leukemia, acute myeloid leukemia, prolymphocytic leukemia, multiple myeloma, or a myelodysplastic syndrome
• Expected survival of approximately 1 year or less with conventional therapy
• No active CNS involvement by malignancy
• Must have a parent, sibling, or adult child who shares one haplotype to be stem cell donor
• Recovered from prior treatment
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 200,000/mm³ (without transfusion)
• ALT and AST ≤ 2.5 X upper limit of normal (ULN)
• Bilirubin ≤ 2.5 X ULN
• Unconjugated hyperbilirubinemia consistent with Gilbert’s syndrome allowed
• No chronic active hepatitis B infection
• Hepatitis B core antibody positive allowed provided patient is surface antigen negative and has no evidence of active infection
• No hepatitis C viral infection
• Seronegative for anti-hepatitis C antibody and detectable hepatitis C viral RNA by reverse transcriptase-polymerase chain reaction assay
• Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
• LVEF ≥ 45%
• DLCO ≥ 50% of expected value (corrected for blood hemoglobin level and alveolar volume)
• Not pregnant or nursing; fertile patients must use effective contraception during and for 1 year after study participation
• HIV negative
• No medical condition that would preclude study participation

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Treatment Plan:

This is a pilot study.

Induction Chemotherapy:

• Patients receive one of two induction chemotherapy regimens according to diagnosis
• Regimen A
• Patients receive rituximab IV (if they have CD20+ B-cell malignancies) on Day 1; fludarabine IV over 30 minutes on Days 1–4; etoposide, doxorubicin, and vincristine IV continuously on Days 1–4; cyclophosphamide IV over 30 minutes on Day 5; oral prednisone on Days 1–5; and filgrastim (G-CSF) subcutaneously (SC) beginning on Day 6 and continuing until blood counts recover
• Regimen B
• Patients receive G-CSF SC beginning 24 hours before initiating induction chemotherapy and continuing until blood counts recover
• Patients also receive fludarabine IV over 30 minutes and cytarabine IV over 4 hours on Days 1–5
• For both regimens, treatment repeats every 21 days for 1–3 courses
• Patients who achieve remission or who have responsive or stable disease after induction chemotherapy then proceed to transplantation preparative regimen chemotherapy

Transplantation Preparative Regimen Chemotherapy:

• Patients receive fludarabine IV over 30 minutes and cyclophosphamide IV over 2 hours on Days -6 to -3

Graft-versus-host disease (GVHD) prophylaxis:

• Patients receive cyclosporine IV over 2 hours twice daily beginning on Day -1 and continuing IV or orally until Day 100
• Patients with no acute GVHD at Day 100 taper cyclosporine over 12 weeks

Allogeneic stem cell transplantation (SCT):

• Patients undergo T-cell-depleted allogeneic peripheral blood SCT on Day 0
• Patients receive G-CSF SC beginning on Day 0 and continuing until blood counts recover

Donor lymphocyte infusion (DLI):

• Patients with persistent or progressive malignant disease after transplantation or mixed chimerism that does not improve after tapering or discontinuing immunosuppression therapy may receive DLI
• DLI may be administered alone or in combination with chemotherapy
• DLI repeats every 4 weeks until adequate donor chimerism is achieved or until GVHD develops

• Patients are followed at 28 and 100 days and then at 6, 9, 12, 18, and 24 months

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 7/7/08
Updated: 1/14/09