Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer

Terminated

• Conditions: Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic/Myeloproliferative Neoplasms; Myelodysplastic Syndromes; Adult Langerhans Cell Histiocytosis; Childhood Langerhans Cell Histiocytosis
• Interventions: Procedure: Peripheral Blood Stem Cell Transplantation

• Registration Number: NCT00008216
• Lead Sponsor: Columbia University

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.

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 Timeline

• Study Start: 1996-07
• Study First Submitted: 2001-01-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-05
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
alloSCT group	Peripheral Blood Stem Cell Transplantation	Patients undergoing allogeneic blood or marrow stem cell transplantation (alloSCT).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Survival rate	6 months
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).
Time to treatment failure and relapse	6 months	Time from day 1 of chemoradiotherapy to transplant-related death or disease relapse.
Number of participants with Graft-versus-host disease	6 months

Trial Locations

Locations (1)

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center; 🇺🇸 New York, New York, United States