Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma

Sponsor

Cancer Research UK (Other)

Overall Status

Unknown status

CT.gov ID

NCT00720447

Collaborator

(none)

Enrollment

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Biological: alemtuzumab Biological: donor lymphocytes Drug: carmustine Drug: cytarabine Drug: etoposide Drug: melphalan Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Non-Randomized

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2008

Anticipated Primary Completion Date :

Nov 1, 2010

Outcome Measures

Primary Outcome Measures

Progression-free survival []

Secondary Outcome Measures

Overall survival []
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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