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

NCT ID: NCT00907036

Last Updated: 2013-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31

Brief 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.

Detailed Description

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.

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

alemtuzumab

Intervention Type: BIOLOGICAL

donor lymphocytes

Intervention Type: BIOLOGICAL

cyclosporine

Intervention Type: DRUG

fludarabine phosphate

Intervention Type: DRUG

melphalan

Intervention Type: DRUG

allogeneic hematopoietic stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Research UK

OTHER

Sponsor Role: lead

Principal Investigators

Karl Peggs, MD

Role: PRINCIPAL_INVESTIGATOR

University College London (UCL) Cancer Institute

Other Identifiers

CDR0000640500

Identifier Type: REGISTRY

Identifier Source: secondary_id

EUDRACT-2008-004956-60

Identifier Type: -

Identifier Source: secondary_id

EU-20928

Identifier Type: -

Identifier Source: secondary_id

UCL/08/0122

Identifier Type: -

Identifier Source: secondary_id

CRUK-ReACH

Identifier Type: -

Identifier Source: org_study_id