Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-26 @ 1:37 PM
Study NCT ID:
NCT00806767
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2008-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fludarabine, Busulfan, and Antilymphocyte Globulin Followed by Donor Stem Cell Transplant in Treating Older Patients With Hematological Cancer
Sponsor:
Institut Paoli-Calmettes
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: