Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

January 6, 2001

Last Updated Date

April 24, 2009

Start Date ^ICMJE

January 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Safety [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety

Change History

Complete list of historical versions of study NCT00008216 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical response [ Designated as safety issue: No ]
Survival rate [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Clinical response
Survival rate

Descriptive Information

Brief Title ^ICMJE

Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer

Official Title ^ICMJE

The Use Of Peripheral Blood Stem Cells For Allogeneic Transplantation

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Adult Langerhans Cell Histiocytosis
Childhood Langerhans Cell Histiocytosis
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases

Intervention ^ICMJE

Procedure: peripheral blood stem cell transplantation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00008216

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068388, CPMC-IRB-AAAA5571, CPMC-CAMP-016, NCI-G00-1891

Study Sponsor ^ICMJE

Herbert Irving Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

David G. Savage, MD

Herbert Irving Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP