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 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 19, 2008
Last updated: August 1, 2013
Last verified: July 2011

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
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:

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)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00720447

Sponsors and Collaborators
Cancer Research UK
Principal Investigator: Simon Rule, MD Derriford Hospital
  More Information Identifier: NCT00720447     History of Changes
Other Study ID Numbers: UCL-BRD-07-137  CDR0000597903  EUDRACT 2007-003081-18 
Study First Received: July 19, 2008
Last Updated: August 1, 2013
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, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on May 24, 2016