Clinical Trial: Non-Ablative Allo HSCT For Hematologic Malignancies or SAA

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Purine-Analog-Containing Non-Myeloablative Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies and Severe Aplastic Anemia

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have hematologic cancer or aplastic anemia.


Detailed Summary:

OBJECTIVES:

  • Determine the rates of durable full donor hematologic engraftment in patients with high-risk hematologic malignancies or severe aplastic anemia treated with non-myeloablative conditioning using fludarabine, cyclophosphamide, and anti-thymocyte globulin followed by allogeneic peripheral blood stem cell transplantation.
  • Determine the acute and delayed toxic effects of this non-myeloablative conditioning regimen in this patient population.
  • Determine the event-free and overall survival of patients treated with this regimen.
  • Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.
  • Determine the rate and quality of immune reconstitution in patients treated with this regimen.
  • Determine the rate of disease relapse and incidence of post-transplantation lymphoproliferative disease in these patients.

OUTLINE: Patients are stratified according to disease category (malignant vs non-malignant) and graft source (unrelated vs HLA-matched sibling).

Beginning at least 4 weeks after conventional-dose chemotherapy, patients receive non-myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -4, cyclophosphamide IV over 2 hours on days -3 to -2, and anti-thymocyte globulin IV over at least 4 hours on days -2 and -1. Patients undergo filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation on day 0.

Patients are followed weekly for 3 months, every 2 weeks for 3 months, monthly for 6 months, and then every 2
Sponsor: Case Comprehensive Cancer Center

Current Primary Outcome: Evaluation of Donor Engraftment [ Time Frame: at 28 days ]

Peripheral blood from the donor and patient is obtained for chimerism studies. The primary analysis will consist of estimating the graft failure proportions for each of the separate patient groups and calculating confidence intervals for these proportions. This analysis will be done conditional on patients surviving at least 28 days.


Original Primary Outcome:

Current Secondary Outcome:

  • Stable donor hematopoietic chimerism [ Time Frame: at day 100 ]
    Number of Patients Transplanted More Than 100 Days Ago
  • Event free and overall survival [ Time Frame: to progression/death ]


Original Secondary Outcome:

Information By: Case Comprehensive Cancer Center

Dates:
Date Received: October 4, 2000
Date Started: June 2000
Date Completion:
Last Updated: December 7, 2011
Last Verified: December 2011