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Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma

NCT ID: NCT00720447

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

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.

Conditions

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Lymphoma

Keywords

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stage III mantle cell lymphoma stage IV mantle cell lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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alemtuzumab

Intervention Type BIOLOGICAL

donor lymphocytes

Intervention Type BIOLOGICAL

carmustine

Intervention Type DRUG

cytarabine

Intervention Type DRUG

etoposide

Intervention Type DRUG

melphalan

Intervention Type DRUG

allogeneic bone marrow transplantation

Intervention Type PROCEDURE

peripheral blood stem cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research UK

OTHER

Sponsor Role lead

Principal Investigators

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Simon Rule, MD

Role: PRINCIPAL_INVESTIGATOR

Derriford Hospital

Other Identifiers

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CDR0000597903

Identifier Type: REGISTRY

Identifier Source: secondary_id

EUDRACT 2007-003081-18

Identifier Type: -

Identifier Source: secondary_id

UCL-BRD-07-137

Identifier Type: -

Identifier Source: org_study_id