Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2007 by National Cancer Institute (NCI). Recruitment status was Recruiting

First Received on January 6, 2001. Last Updated on June 4, 2011 History of Changes

Sponsor:	Herbert Irving Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00008216

Purpose

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.

Condition	Intervention	Phase
Adult Langerhans Cell Histiocytosis Childhood Langerhans Cell Histiocytosis Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms	Procedure: peripheral blood stem cell transplantation	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	The Use Of Peripheral Blood Stem Cells For Allogeneic Transplantation

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia Langerhans cell histiocytosis

MedlinePlus related topics: Acute Lymphocytic Leukemia Acute Myeloid Leukemia Cancer Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Hodgkin Disease Leukemia Lymphoma Multiple Myeloma Myelodysplastic Syndromes

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Estimated Enrollment:	62
Study Start Date:	January 1997

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.

Eligibility

Ages Eligible for Study:	up to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008216

Locations

United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	Recruiting
New York, New York, United States, 10032
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615

Sponsors and Collaborators

Herbert Irving Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

David G. Savage, MD

Herbert Irving Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00008216 History of Changes
Other Study ID Numbers:	CDR0000068388, CPMC-IRB-AAAA5571, CPMC-CAMP-016, NCI-G00-1891
Study First Received:	January 6, 2001
Last Updated:	June 4, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IV adult Hodgkin lymphoma
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia

relapsing chronic myelogenous leukemia
childhood Langerhans cell histiocytosis
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
untreated childhood acute lymphoblastic leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
chronic myelogenous leukemia, BCR-ABL1 positive

Additional relevant MeSH terms:

Neoplasms
Histiocytosis
Histiocytosis, Langerhans-Cell
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Lymphoma, Large-Cell, Immunoblastic
Myelodysplastic-Myeloproliferative Diseases
Lymphatic Diseases

Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases

ClinicalTrials.gov processed this record on February 12, 2012