Fludarabine, Busulfan, and Antilymphocyte Globulin Followed by Donor Stem Cell Transplant in Treating Older Patients With Hematological Cancer
Official Title
Phase II Study of Allogeneic Transplant of Hematopoietic Stem Cells From a Compatible Family Donor in the Treatment of Patients Over 55 Years With Hematological Malignancies
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Jul 2009
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 2007
Primary Completion Date
May 2011Actual
Completion Date
Not provided
First Submitted Date
Dec 10, 2008
First Submission Date that Met QC Criteria
Dec 10, 2008
First Posted Date
Dec 11, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 14, 2011
Last Update Posted Date
May 17, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Institut Paoli-CalmettesOTHER
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antilymphocyte globulin before transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well fludarabine, busulfan, and antilymphocyte globulin together with donor stem cell transplant works in treating older patients with hematological cancer.
Detailed Description
OBJECTIVES:
Primary
To assess non-relapse or progression-related mortality at 1 year in patients over 55 with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation from a matched related, filgrastim (G-CSF)-mobilized donor and treated with conditioning comprising fludarabine phosphate, busulfan, and anti-lymphocyte globulin.
To assess the incidence of graft-versus-host disease in these patients.
To assess the incidence of relapse in these patients.
To assess cellular recovery in these patients.
To assess myeloid and lymphocyte chimerism in these patients.
Secondary
To study the usual clinical and biological aspects of the transplantation in these patients.
To study the impact of the Charlson score and the suitability for allogeneic transplantation score on mortality and 1-year survival.
To assess the quality of life (QLQ-C30) of these patients.
To study the economic cost of transplantation from conditioning to 1 year post-transplant.
To study the mobilization and collection of progenitor stem cells in the donors.
To study the psychological impact of donating stem cells on the donors.
OUTLINE: This is a multicenter study.
Conditioning: Patients receive fludarabine phosphate IV over 30 minutes on days -5 through -1, busulphan IV over 2 hours every 6 hours on days -4 and -3, and anti-lymphocyte globulin IV over 4 hours on days -2 and -1.
Transplantation: Patients undergo allogeneic hematopoietic stem call transplantation on day 0.
Patients complete a quality of life survey (QLQ-C30). After completion of study treatment, patients are followed every month for 6 months and then every 3 months for 6 months.
Conditions Module
Conditions
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Keywords
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma