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Bone Marrow Transplantation in Treating Patients With Chronic Lymphocytic Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide
Allogeneic Bone Marrow Transplantation
Autologous Bone Marrow Transplantation
Total Body Irradiation (TBI)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring refractory chronic lymphocytic leukemia, Cyclophosphamide, Cytoxan, Neosar, Bone Marrow Transplantation, total body irradiation, chronic lymphocytic leukemia, allogeneic, autologous

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Chronic lymphocytic leukemia (CLL) patients after initial relapse who have achieved a complete or partial remission with fludarabine therapy or after initial relapse or progression Prolymphocytic leukemia in first remission or after relapse Patients 15-65 years old who lack an HLA-identical sibling are eligible for autologous BM transplantation Patients 16-50 years old with an HLA identical or one antigen mismatched related donor are eligible for allogeneic BM transplantation 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

Sites / Locations

  • University of Texas - MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyclophosphamide + TBI + BMT

Arm Description

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

Outcomes

Primary Outcome Measures

Effectiveness of high dose cyclophosphamide, total body irradiation and bone marrow transplantation for chronic lymphocytic leukemia

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
October 23, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002844
Brief Title
Bone Marrow Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Official Title
Bone Marrow Transplantation for Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 5, 1991 (undefined)
Primary Completion Date
June 5, 2002 (Actual)
Study Completion Date
June 5, 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
refractory chronic lymphocytic leukemia, Cyclophosphamide, Cytoxan, Neosar, Bone Marrow Transplantation, total body irradiation, chronic lymphocytic leukemia, allogeneic, autologous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclophosphamide + TBI + BMT
Arm Type
Experimental
Arm Description
TBI = Total Body Irradiation and BMT = Bone Marrow Transplantation (allogeneic or autologous bone marrow)
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan, Neosar
Intervention Description
Daily intravenous infusions of cyclophosphamide for two days,
Intervention Type
Procedure
Intervention Name(s)
Allogeneic Bone Marrow Transplantation
Other Intervention Name(s)
Stem Cell Transplant
Intervention Description
After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
Intervention Type
Procedure
Intervention Name(s)
Autologous Bone Marrow Transplantation
Other Intervention Name(s)
Stem Cell Transplant
Intervention Description
After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
Intervention Type
Radiation
Intervention Name(s)
Total Body Irradiation (TBI)
Other Intervention Name(s)
radiation therapy
Intervention Description
Following 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant.
Primary Outcome Measure Information:
Title
Effectiveness of high dose cyclophosphamide, total body irradiation and bone marrow transplantation for chronic lymphocytic leukemia
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Chronic lymphocytic leukemia (CLL) patients after initial relapse who have achieved a complete or partial remission with fludarabine therapy or after initial relapse or progression Prolymphocytic leukemia in first remission or after relapse Patients 15-65 years old who lack an HLA-identical sibling are eligible for autologous BM transplantation Patients 16-50 years old with an HLA identical or one antigen mismatched related donor are eligible for allogeneic BM transplantation 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard E. Champlin, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center Website

Learn more about this trial

Bone Marrow Transplantation in Treating Patients With Chronic Lymphocytic Leukemia

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