Non-Ablative Allo HSCT For Hematologic Malignancies or SAA
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|ClinicalTrials.gov Identifier: NCT00006379|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition Small Intestine Cancer||Biological: anti-thymocyte globulin Biological: graft-versus-tumor induction therapy Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation||Phase 2|
- 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 months thereafter.
PROJECTED ACCRUAL: A minimum of 30 patients will be accrued for this study within 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Purine-Analog-Containing Non-Myeloablative Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies and Severe Aplastic Anemia|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||January 2004|
|Actual Study Completion Date :||October 2011|
Biological: anti-thymocyte globulin
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006379
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Tamila Kindwall-Keller, DO||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|