Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by National Cancer Institute (NCI).
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Cancer Research UK
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00720447
First received: July 19, 2008
Last updated: February 6, 2009
Last verified: July 2008
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Phase II Study of Low Intensity Allogeneic Transplantation in Mantle Cell Lymphoma |
Resource links provided by NLM:
Drug Information available for:
Cytarabine
Melphalan
Carmustine
Melphalan hydrochloride
Etoposide
Etoposide phosphate
Alemtuzumab
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Progression-free survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 25 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00720447 History of Changes |
| Other Study ID Numbers: | CDR0000597903, UCL-BRD/07/137, EUDRACT 2007-003081-18 |
| Study First Received: | July 19, 2008 |
| Last Updated: | February 6, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage III mantle cell lymphoma stage IV mantle cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Carmustine Melphalan Alemtuzumab Cytarabine Etoposide Campath 1G |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Myeloablative Agonists |
ClinicalTrials.gov processed this record on June 13, 2013