Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer
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|ClinicalTrials.gov Identifier: NCT00008216|
Recruitment Status : Terminated (Poor enrollment)
First Posted : January 27, 2003
Last Update Posted : June 6, 2014
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|
|Adult Langerhans Cell Histiocytosis Childhood Langerhans Cell Histiocytosis Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms||Procedure: Peripheral Blood Stem Cell Transplantation||Phase 2|
- 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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||48 participants|
|Target Follow-Up Duration:||36 Months|
|Official Title:||The Use Of Peripheral Blood Stem Cells For Allogeneic Transplantation|
|Study Start Date :||July 1996|
|Primary Completion Date :||January 2009|
|Study Completion Date :||January 2009|
Patients undergoing allogeneic blood or marrow stem cell transplantation (alloSCT).
|Procedure: Peripheral Blood Stem Cell Transplantation|
- Toxicity [ Time Frame: 6 months ]Number of irreversible severe (grade 3) or life-threatening or lethal (grade 4-5) organ toxicities.
- Time to engraftment [ Time Frame: 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.
- Clinical response [ Time Frame: 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 [ Time Frame: 6 months ]
- Number of participants with Graft-versus-host disease [ Time Frame: 6 months ]
- Time to treatment failure and relapse [ Time Frame: 6 months ]Time from day 1 of chemoradiotherapy to transplant-related death or disease relapse.
Biospecimen Retention: Samples Without DNA
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): NCT00008216
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||David G. Savage, MD||Herbert Irving Comprehensive Cancer Center|