Clinical Trials (PDQ®) - National Cancer Institute

Page Options

Clinical Trial Questions?

Get Help:

	Quick Links


	Help Using the NCI Clinical Trials Search Form Educational Materials About Clinical Trials About NCI's Cancer Clinical Trials Registry Dictionary of Cancer Terms NCI Drug Dictionary

Phase II Study of Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematologic Malignancy

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Active 65 and under NCI CPMC-IRB-AAAA5571
CPMC-CAMP-016, NCI-G00-1891, NCT00008216

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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Patient Characteristics:

Age:

65 and under

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Expected Enrollment

A total of 62 patients will be accrued for this study within 4 years.

Outcomes

Primary Outcome(s)

Safety

Secondary Outcome(s)

Clinical response
Survival rate

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.

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

David Savage, MD, Protocol chair
Ph: 212-305-9783

Trial Sites

U.S.A.

New York

New York

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Ph: 212-305-8615

Registry Information

Official Title		The Use Of Peripheral Blood Stem Cells For Allogeneic Transplantation

Trial Start Date		1997-01-01

Registered in ClinicalTrials.gov		NCT00008216

Date Submitted to PDQ		2000-11-16

Information Last Verified		2007-01-15

NCI Grant/Contract Number		P30-CA13696

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.