Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer

Columbia University

Status: Terminated

Conditions: Multiple Myeloma and Plasma Cell Neoplasm; Adult Langerhans Cell Histiocytosis; Childhood Langerhans Cell Histiocytosis; Lymphoma; Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Treatments: Procedure: Peripheral Blood Stem Cell Transplantation

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00008216

AAAA5571

CPMC-CAMP-016

CPMC-IRB-AAAA5571

NCI-G00-1891

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

48 participants in 1 patient group

alloSCT group

Description:

Patients undergoing allogeneic blood or marrow stem cell transplantation (alloSCT).

Treatment:

Procedure: Peripheral Blood Stem Cell Transplantation