- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00720447
Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma
Phase II Study of Low Intensity Allogeneic Transplantation in Mantle Cell Lymphoma
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Progression-free survival
|
Secondary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Overall survival
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Simon Rule, MD, Derriford Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Mantle-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Etoposide
- Melphalan
- Cytarabine
- Carmustine
- Alemtuzumab
Other Study ID Numbers
- UCL-BRD-07-137
- CDR0000597903 (Registry Identifier: PDQ (Physician Data Query))
- EUDRACT 2007-003081-18
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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