NCT00006379

Non-Ablative Allo HSCT For Hematologic Malignancies or SAA

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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 description

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 months thereafter. PROJECTED ACCRUAL: A minimum of 30 patients will be accrued for this study within 4 years.

Conditions

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Diseases
• Precancerous/Nonmalignant Condition
• Small Intestine Cancer

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin	anti-thymocyte globulin IV over at least 4 hours on days -2 and -1
BIOLOGICAL	graft-versus-tumor induction therapy	Patients undergo filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation on day 0.
DRUG	cyclophosphamide	cyclophosphamide IV over 2 hours on days -3 to -2
DRUG	fludarabine phosphate	fludarabine IV over 30 minutes on days -8 to -4
PROCEDURE	peripheral blood stem cell transplantation	Patients undergo filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation on day 0.

Timeline

• Start date: 2000-06-01
• Primary completion: 2004-01-01
• Completion: 2011-10-01
• First posted: 2003-01-27
• Last updated: 2011-12-08

Locations

1 site across 1 country: United States