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Investigator(s):
Daniel H. Fowler, M.D. Principal Investigator Phone: 301-435-8641 Fax: 301-451-5578 dhfowler@helix.nih.gov
Referral Contact(s):
Zetta Blacklock, R.N., B.S., B.S.N. Transplant Coordinator Phone: 301-594-2056 Fax: 301-451-5578 bblacklock@mail.nih.gov	Sheila Phang, R.N., M.S. Transplant Coordinator Phone: 301-435-9379 Fax: 301-451-5578 sphang@mail.nih.gov

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Key Eligibility Criteria:

• Diagnosis of Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, chronic myelogenous leukemia, chronic lymphocytic leukemia, acute lymphocytic leukemia, acute myeloid leukemia, myelodysplastic syndromes, multiple myeloma, or myeloproliferative disorders
• Acute leukemia must be in hematologic remission (< 10% blood or marrow blasts)
• Primary treatment failure
• Consenting sibling with 6/6 human leukocyte antigen (HLA) match
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• No active central nervous system involvement by malignancy
• ALT and AST ≤ 2.5 x upper limit of normal (ULN)
• Bilirubin ≤ 2.5 mg/dL
• Creatinine ≥ 1.5 mg/dL AND creatinine clearance at least 50 mL/min
• LVEF > 45% by two-dimensional ECHO or MUGA
• DLCO > 50% of expected
• Not pregnant or nursing; fertile patients must use effective contraception during and for at least 1 year after study participation
• HIV negative
• No medical condition that would preclude study participation

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Study Outline:

This is a multicenter pilot study. Patients are stratified according to age (18–45 vs 46–75).

Induction chemotherapy:

• Patients with CD20+ B-cell malignancies receive rituximab intravenously (IV) on Day 1
• All patients receive fludarabine IV over 30 minutes and 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
• Treatment repeats every 21 days for 1–3 courses depending on the quantity of host immune T cells remaining after each course
• All patients, including those who develop progressive disease during induction chemotherapy, then proceed to transplantation chemotherapy

Transplantation chemotherapy:

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

Allogeneic transplantation:

• Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on Day 0
• Patients receive G-CSF SC beginning on Day 0 and continuing until blood counts recover
• Patients also receive cyclosporine orally or IV over 2 hours twice daily beginning on Day -1 and continuing until approximately Day 100 followed by a taper until Day 180
• Patients are sequentially assigned to groups below:
• Group 1 (closed to accrual):
• Patients receive donor Th2 cells IV on Day 1
• Group 2 (closed to accrual):
• Patients receive donor Th2 cells IV on Day 14
• Patients also receive an initial loading dose of oral sirolimus once on Day -2 and then oral sirolimus once daily on Days -1 to 14
• Group 3 (closed to accrual):
• Patients receive oral sirolimus as in group 2
• Group 4:
• Patients receive treatment as in group 2

Donor lymphocyte infusion (DLI):

• Patients with persistent or progressive malignant disease after transplantation may receive DLI; DLI may be administered alone or in combination with chemotherapy

• Treatment continues in the absence of disease progression or unacceptable toxicity
• Patients are followed twice weekly for 100 days post-transplantation, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter

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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, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/6/12
Updated: 12/1/11