Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer
Status:
Terminated
Sponsors
Columbia University
Collaborators
National Cancer Institute (NCI)
Abstract:
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.
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.
Last Verified:May/31/2014
First Submitted:January/5/2001
Estimated Enrollment Submitted:January/25/2003
First Posted:January/26/2003
Last Update Submitted:June/4/2014
Last Update Posted:June/5/2014
Actual Study Start Date:June/30/1996
Estimated Primary Completion Date:December/31/2008
Estimated Study Completion Date:December/31/2008
Condition or disease:Adult Langerhans Cell Histiocytosis
Childhood Langerhans Cell Histiocytosis
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Intervention/treatment:
Procedure: alloSCT group
Phase:-
Study design:
Study Type:Observational [Patient Registry]
Observational Model:Cohort
Time Perspective:Prospective
Arm group:
ArmIntervention/treatment
alloSCT group
Patients undergoing allogeneic blood or marrow stem cell transplantation (alloSCT).
Procedure: alloSCT group
Eligibility Criteria:
Ages Eligible for Study:18 Years to 18 Years
Sexes Eligible for Study:All
Sampling method:Non-Probability Sample
Accepts Healthy Volunteers:Yes
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

Outcome:
Primary Outcome Measures
1. Toxicity [6 months]
Number of irreversible severe (grade 3) or life-threatening or lethal (grade 4-5) organ toxicities.
2. 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
1. 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).
2. Survival rate [6 months]
3. Number of participants with Graft-versus-host disease [6 months]
4. Time to treatment failure and relapse [6 months]
Time from day 1 of chemoradiotherapy to transplant-related death or disease relapse.
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