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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00720447
First received: July 19, 2008
Last updated: August 1, 2013
Last verified: July 2011
  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:


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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720447

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

Additional Information:
No publications provided

ClinicalTrials.gov 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
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 July 28, 2014