Bone Marrow Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: Cyclophosphamide Procedure: Allogeneic Bone Marrow Transplantation Procedure: Autologous Bone Marrow Transplantation Radiation: Total Body Irradiation (TBI) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Bone Marrow Transplantation for Chronic Lymphocytic Leukemia |
- Effectiveness of high dose cyclophosphamide, total body irradiation and bone marrow transplantation for chronic lymphocytic leukemia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 49 |
| Study Start Date: | March 1991 |
| Study Completion Date: | June 2002 |
| Primary Completion Date: | July 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cyclophosphamide + TBI + BMT
TBI = Total Body Irradiation and BMT = Bone Marrow Transplantation (allogeneic or autologous bone marrow)
|
Drug: Cyclophosphamide
Daily intravenous infusions of cyclophosphamide for two days,
Other Names:
Procedure: Allogeneic Bone Marrow Transplantation
After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
Other Name: Stem Cell Transplant
Procedure: Autologous Bone Marrow Transplantation
After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
Other Name: Stem Cell Transplant
Radiation: Total Body Irradiation (TBI)
Following 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant.
Other Name: radiation therapy
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Richard E. Champlin, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00002844 History of Changes |
| Other Study ID Numbers: | DM90-106, P30CA016672, MDA-DM-90106, NCI-G96-1034, CDR0000065081 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by M.D. Anderson Cancer Center:
|
refractory chronic lymphocytic leukemia Cyclophosphamide Cytoxan Neosar Bone Marrow Transplantation |
total body irradiation chronic lymphocytic leukemia allogeneic autologous |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 16, 2013