Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma

Study Overview
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Brief Summary
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RATIONALE: Giving chemotherapy and monoclonal antibody therapy 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. 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. PURPOSE: This phase II trial is studying donor stem cell transplant in treating patients with mantle cell lymphoma.

Detailed Description
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OBJECTIVES: Primary Determine progression-free survival in patients with mantle cell lymphoma undergoing low-intensity allogeneic stem cell transplantation. Secondary Determine overall survival of these patients. Determine the toxicity by way of adverse event profile of this regimen in these patients. OUTLINE: This is a multicenter study. Reduced intensity conditioning: Patients receive carmustine IV over 2 hours on day -6, etoposide IV over 1 hour and cytarabine IV over 15 minutes on days -5 to -2, alemtuzumab IV over 2 hours on days -5 to -1, and melphalan IV on day -1. Donor stem cell transplant: Patients undergo stem cell transplantation on day 0 with filgrastim (G-CSF)-mobilized peripheral blood stem cells or bone marrow stem cells. Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV or orally on day -1 to 30 and taper to day 100. Donor lymphocyte infusion (DLI) therapy: Patients with evidence of disease progression, mixed chimerism, or low level residual disease undergo DLI every 3 months for up to 15 months in the absence of GVHD. After completion of study, patients are followed every 3 months for 2 years.

Official Title
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Phase II Study of Low Intensity Allogeneic Transplantation in Mantle Cell Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: alemtuzumab
* Biological: donor lymphocytes
* Drug: carmustine
* Drug: cytarabine
* Drug: etoposide
* Drug: melphalan
* Procedure: allogeneic bone marrow transplantation
* Procedure: peripheral blood stem cell transplantation


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of mantle cell lymphoma No relapsed or progressive disease Achieved at least a partial remission following induction chemotherapy HLA-matched donor available Blood samples from both patient and donor available for chimerism studies No central nervous system involvement PATIENT CHARACTERISTICS: ECOG performance status 2-4 Considered fit for transplant by treating physician Serum bilirubin ≤ 1.5 times upper limit of normal Alkaline phosphatase ≤ 2 times normal Creatinine clearance ≥ 50 mL/min Ejection fraction > 50% (no inadequate cardiac function) Not pregnant or nursing Negative pregnancy test No symptomatic respiratory compromise No serious concurrent disease which would preclude allograft No known serological positivity for hepatitis B, hepatitis C, or HIV No history of a psychological illness or condition that would affect compliance No previous malignancy within the past 5 years except nonmelanoma skin tumors or stage 0 (in situ) cervical carcinoma PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: alemtuzumab|nan|
|Biological: donor lymphocytes|nan|
|Drug: carmustine|nan|
|Drug: cytarabine|nan|
|Drug: etoposide|nan|
|Drug: melphalan|nan|
|Procedure: allogeneic bone marrow transplantation|nan|
|Procedure: peripheral blood stem cell transplantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III mantle cell lymphoma, stage IV mantle cell lymphoma