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Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
alemtuzumab
donor lymphocytes
carmustine
cytarabine
etoposide
melphalan
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Sponsored by
Cancer Research UK
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage III mantle cell lymphoma, stage IV mantle cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Progression-free survival

    Secondary Outcome Measures

    Overall survival
    Toxicity

    Full Information

    First Posted
    July 19, 2008
    Last Updated
    August 1, 2013
    Sponsor
    Cancer Research UK
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00720447
    Brief Title
    Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma
    Official Title
    Phase II Study of Low Intensity Allogeneic Transplantation in Mantle Cell Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    November 2010 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Cancer Research UK

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma
    Keywords
    stage III mantle cell lymphoma, stage IV mantle cell lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Allocation
    Non-Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    alemtuzumab
    Intervention Type
    Biological
    Intervention Name(s)
    donor lymphocytes
    Intervention Type
    Drug
    Intervention Name(s)
    carmustine
    Intervention Type
    Drug
    Intervention Name(s)
    cytarabine
    Intervention Type
    Drug
    Intervention Name(s)
    etoposide
    Intervention Type
    Drug
    Intervention Name(s)
    melphalan
    Intervention Type
    Procedure
    Intervention Name(s)
    allogeneic bone marrow transplantation
    Intervention Type
    Procedure
    Intervention Name(s)
    peripheral blood stem cell transplantation
    Primary Outcome Measure Information:
    Title
    Progression-free survival
    Secondary Outcome Measure Information:
    Title
    Overall survival
    Title
    Toxicity

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Simon Rule, MD
    Organizational Affiliation
    Derriford Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma

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