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Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00720447
Recruitment Status : Unknown
Verified July 2011 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
First Posted : July 22, 2008
Last Update Posted : August 2, 2013
Information provided by:
National Cancer Institute (NCI)

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:



  • Determine progression-free survival in patients with mantle cell lymphoma undergoing low-intensity allogeneic stem cell transplantation.


  • 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 : Interventional  (Clinical Trial)
Estimated 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 : November 2008
Estimated Primary Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Progression-free survival

Secondary Outcome Measures :
  1. Overall survival
  2. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720447

Sponsors and Collaborators
Cancer Research UK
Principal Investigator: Simon Rule, MD Derriford Hospital

ClinicalTrials.gov Identifier: NCT00720447     History of Changes
Other Study ID Numbers: UCL-BRD-07-137
CDR0000597903 ( Registry Identifier: PDQ (Physician Data Query) )
EUDRACT 2007-003081-18
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: July 2011

Keywords provided by National Cancer Institute (NCI):
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists