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

NCT00907036 | Unknown Phase 2

• 5 other identifiers: CRUK-ReACHCDR0000640500EUDRACT-2008-004956-60EU-20928UCL/08/0122
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• 3-year progression-free survival

Secondary Outcomes (8)

• Donor engraftment rates, including chimerism at 3 and 6 months

• Non-relapse mortality at 100 days and at 1 and 2 years post-transplant

• Incidence of grade II-IV toxicity as assessed by NCI CTCAE v3.0

• Incidence, severity, and timing of graft-vs-host disease

• Response rates

Interventions

alemtuzumab BIOLOGICAL

donor lymphocytes BIOLOGICAL

cyclosporine DRUG

fludarabine phosphate DRUG

melphalan DRUG

allogeneic hematopoietic stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Alemtuzumab; Cyclosporine; fludarabine phosphate; Melphalan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids

Study Officials

• Karl Peggs, MD

  University College London (UCL) Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 22, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2015
• Last Updated: August 2, 2013

Record last verified: 2009-06