Overview

Fludarabine Phosphate, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed Hodgkin Lymphoma

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect. PURPOSE: This phase II trial is studying the side effects of fludarabine phosphate, melphalan, and alemtuzumab followed by donor stem cell transplant in treating patients with relapsed Hodgkin lymphoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cancer Research UK
Treatments:
Alemtuzumab
Cyclosporine
Cyclosporins
Fludarabine
Fludarabine phosphate
Melphalan
Vidarabine
Criteria
DISEASE CHARACTERISTICS:

- Confirmed diagnosis of Hodgkin lymphoma, meeting all of the following criteria:

- Achieved partial or complete remission (using standard criteria) after salvage
chemotherapy

- Relapsed after first remission with residual fludeoxyglucose F 18-avid lesions

- Available HLA-matched sibling donor

PATIENT CHARACTERISTICS:

- WHO performance status 0-1

- Creatinine clearance ≥ 50 mL/min (measured by EDTA clearance or 24-hour urine
collection)

- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2 times ULN

- LVEF ≥ 40%

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months (or 3 months
for women) after completion of study therapy

- No other malignancy within the past 5 years except for nonmelanoma skin tumors or
stage 0 (in situ) cervical carcinoma

- No HIV positivity

- No symptomatic respiratory compromise

- No concurrent serious medical condition that would preclude transplantation

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior high-dose therapy or allograft