Bone Marrow Transplantation in Treating Patients With Chronic Lymphocytic Leukemia

NCT ID: NCT00002844

Last Updated: 2018-10-25

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-03-05

Study Completion Date

2002-06-05

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with chronic lymphocytic leukemia.

Detailed Description

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OBJECTIVES: Examine the potential role for high dose cyclophosphamide, total body irradiation and bone marrow transplantation for patients with chronic lymphocytic leukemia who are at high risk for disease progression.

OUTLINE: Patients receive daily intravenous infusions of cyclophosphamide for two days, followed by total body irradiation in four daily exposures. After completion of the total body irradiation, allogeneic or autologous bone marrow is infused intravenously.

PROJECTED ACCRUAL: 50 patients are expected to be accrued.

Conditions

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Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cyclophosphamide + TBI + BMT

TBI = Total Body Irradiation and BMT = Bone Marrow Transplantation (allogeneic or autologous bone marrow)

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Daily intravenous infusions of cyclophosphamide for two days,

Allogeneic Bone Marrow Transplantation

Intervention Type PROCEDURE

After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.

Autologous Bone Marrow Transplantation

Intervention Type PROCEDURE

After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.

Total Body Irradiation (TBI)

Intervention Type RADIATION

Following 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant.

Interventions

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Cyclophosphamide

Daily intravenous infusions of cyclophosphamide for two days,

Intervention Type DRUG

Allogeneic Bone Marrow Transplantation

After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.

Intervention Type PROCEDURE

Autologous Bone Marrow Transplantation

After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.

Intervention Type PROCEDURE

Total Body Irradiation (TBI)

Following 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant.

Intervention Type RADIATION

Other Intervention Names

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Cytoxan Neosar Stem Cell Transplant Stem Cell Transplant radiation therapy

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 15-65 (See Disease Characteristics) Performance status: Zubrod no more than 2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Cardiac ejection fraction at least 50% Pulmonary: DLCO at least 50% of predicted Other: No severe concomitant medical or psychiatric illnesses

PRIOR CONCURRENT THERAPY: No extensive prior radiotherapy which would prevent administration of total body radiation Patients may also participate in study MDA-DM-92082 for retroviral gene marking of the autologous marrow and blood cells
Minimum Eligible Age

16 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

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard E. Champlin, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

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University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

UT MD Anderson Cancer Center Website

Other Identifiers

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P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MDA-DM-90106

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-G96-1034

Identifier Type: -

Identifier Source: secondary_id

CDR0000065081

Identifier Type: REGISTRY

Identifier Source: secondary_id

DM90-106

Identifier Type: -

Identifier Source: org_study_id

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