Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer
Study Details
Study Description
Brief Summary
RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying the effectiveness of donor peripheral blood stem cell transplant in treating patients with hematologic cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
OBJECTIVES:
-
Determine the efficacy and safety of allogeneic peripheral blood stem cell transplantation in achieving engraftment in patients with hematologic malignancy.
-
Determine the hematopoietic recovery, incidence of chemoradiotherapeutic toxicity, relapse, graft-versus-host disease, and survival of patients treated with this regimen.
OUTLINE: Patients receive a preparative chemoradiotherapeutic regimen and graft-versus-host disease prophylaxis prior to transplantation. Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
Patients are followed every 1-2 weeks for 6 months and at 9, 12, 24, and 36 months.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| alloSCT group Patients undergoing allogeneic blood or marrow stem cell transplantation (alloSCT). |
Procedure: Peripheral Blood Stem Cell Transplantation
|
Outcome Measures
Primary Outcome Measures
- Toxicity [6 months]
Number of irreversible severe (grade 3) or life-threatening or lethal (grade 4-5) organ toxicities.
- Time to engraftment [6 months]
Days from infusion of stem cells to recovery of PMN > 500/ul for two consecutive determinations, transfusion independence for platelets (>20,000/ul) and RBCs (Hct > 25%). The bone marrow function is considered durable if reconstitution persists for at least 6 months.
Secondary Outcome Measures
- Clinical response [6 months]
Number of participants with a partial response (residual though reduced evidence of active disease) and/or complete response (disappearance of all measurable disease, signs, symptoms, and hematologic or biochemical changes related to the disease, for >3 months).
- Survival rate [6 months]
- Number of participants with Graft-versus-host disease [6 months]
- Time to treatment failure and relapse [6 months]
Time from day 1 of chemoradiotherapy to transplant-related death or disease relapse.
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of one of the following:
-
Chronic myelogenous leukemia
-
Philadelphia chromosome-positive OR
-
Molecular evidence of bcr/abl gene rearrangement
-
Acute myeloid leukemia, acute lymphocytic leukemia, lymphoma, histiocytoses, myelodysplasia, juvenile chronic myelomonocytic leukemia, aplastic anemia, paroxysmal nocturnal hemoglobinuria, or Fanconi's anemia
-
Confirmed by cytochemistry, immunophenotyping, and/or chromosomal abnormalities
-
Multiple myeloma
-
Hereditary immunodeficiency disorders
-
Confirmed by immunologic determination
-
Sickle cell anemia or beta-thalassemia
-
Confirmed by hemoglobin electrophoresis
-
Storage disorders (e.g., Gaucher's disease, Hurler's disease, or metachromatic leukodystrophy)
-
Confirmed by metabolic testing
-
Other non-malignant conditions
-
Eligible for allogeneic peripheral blood stem cell or bone marrow transplantation
PATIENT CHARACTERISTICS:
Age:
- 65 and under
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: David G. Savage, MD, Herbert Irving Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAA5571
- CPMC-IRB-AAAA5571
- CPMC-CAMP-016
- NCI-G00-1891