Fludarabine Phosphate, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed Hodgkin Lymphoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: alemtuzumab Biological: donor lymphocytes Drug: cyclosporine Drug: fludarabine phosphate Drug: melphalan Procedure: allogeneic hematopoietic stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Reduced Intensity Sibling Allogeneic Transplantation for Relapsed, Chemosensitive, PET-positive Hodgkin Lymphoma |
- 3-year progression-free survival [ Designated as safety issue: No ]
- Donor engraftment rates, including chimerism at 3 and 6 months [ Designated as safety issue: No ]
- Non-relapse mortality at 100 days and at 1 and 2 years post-transplant [ Designated as safety issue: No ]
- Incidence of grade II-IV toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Incidence, severity, and timing of graft-vs-host disease [ Designated as safety issue: Yes ]
- Response rates [ Designated as safety issue: No ]
- Relapse rates [ Designated as safety issue: No ]
- Response to donor lymphocyte infusions [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 49 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To document the toxicity, feasibility, and survival after reduced-intensity conditioning followed by allogeneic hematopoietic stem cell transplantation from a matched sibling donor in patients with relapsed, chemosensitive Hodgkin lymphoma.
OUTLINE: This is a multicenter study.
- Reduced-intensity conditioning: Patients receive fludarabine phosphate IV on days -7 to -3, melphalan IV over 30 minutes on day -2, and alemtuzumab IV on day -1.
- Transplantation: Patients undergo donor stem cell infusion on day 0.
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV or orally on days -1 to 60, followed by a taper until 3 months post-transplantation, in the absence of GVHD.
- Donor-lymphocyte infusion (DLI): DLI is used for the eradication of mixed chimerism and for the management of residual or relapsed disease. If necessary, patients undergo DLI every 3 months until the desired endpoint is achieved or GVHD develops.
After completion of study therapy, patients are followed up every 3 months for 3 years.
This study is peer reviewed and funded or endorsed by Cancer Research UK.
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00907036 History of Changes |
| Other Study ID Numbers: | CDR0000640500, CRUK-ReACH, EUDRACT-2008-004956-60, EU-20928, UCL/08/0122 |
| Study First Received: | May 21, 2009 |
| Last Updated: | August 7, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclosporins Cyclosporine Melphalan Fludarabine monophosphate Campath 1G Vidarabine Fludarabine |
Alemtuzumab Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Myeloablative Agonists Antineoplastic Agents Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on June 18, 2013