Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer

NCT ID: NCT00008216

Last Updated: 2014-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-07-31

Study Completion Date

2009-01-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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alloSCT group

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

Peripheral Blood Stem Cell Transplantation

Intervention Type PROCEDURE

Interventions

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Peripheral Blood Stem Cell Transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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David Savage

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David G. Savage, MD

Role: PRINCIPAL_INVESTIGATOR

Herbert Irving Comprehensive Cancer Center

Locations

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Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CPMC-IRB-AAAA5571

Identifier Type: -

Identifier Source: secondary_id

CPMC-CAMP-016

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1891

Identifier Type: -

Identifier Source: secondary_id

AAAA5571

Identifier Type: -

Identifier Source: org_study_id

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