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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002838 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: filgrastim Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | PHASE I/II PILOT STUDY OF ALLOGENEIC PERIPHERAL BLOOD STEM CELL INFUSION FOR PATIENTS WITH HIGH RISK CHRONIC LYMPHOCYTIC LEUKEMIA |
| Estimated Enrollment: | 25 |
| Study Start Date: | December 1995 |
OBJECTIVES: I. Determine the feasibility and toxicity of using allogeneic peripheral blood stem cell transplantation after intensive, but non-myeloablative chemotherapy with fludarabine/cyclophosphamide in patients with advanced chronic lymphocytic leukemia. II. Determine the engraftment kinetics and degree of chimerism available with this strategy.
OUTLINE: This is a nonrandomized, dose-seeking study. Stem cell donors receive G-CSF for 4 days prior to and throughout stem cell harvest. Patients receive intensive chemotherapy with fludarabine and cyclophosphamide for 3 days, with patients entered at increasing doses of both drugs until the dose allowing engraftment is determined.
Three days after intensive chemotherapy, allogeneic stem cells are infused. Responding patients who do not experience worse than grade 1 acute graft-vs.-host disease receive additional stem cell infusions after 60 and 120 days. Patients are followed monthly for 4 months, at 6 and 12 months, then yearly for 5 years.
PROJECTED ACCRUAL: Up to 25 patients will be entered.
Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Advanced chronic lymphocytic leukemia (Rai stage 3 or 4) with at least one of the following high-risk factors: Beta-2 microglobulin 3 or greater Abnormalities of chromosome 17 Other cytogenetic abnormalities Refractory to fludarabine-based chemotherapy or failure to achieve complete remission after 6 courses of a fludarabine-based regimen HLA-identical sibling donor willing and able to undergo apheresis for harvest of G-CSF-stimulated peripheral blood stem cells
PATIENT CHARACTERISTICS: Age: 65 and under Performance status: Zubrod 0 or 1 Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No symptomatic cardiac disease Pulmonary: No symptomatic pulmonary disease Other: No active uncontrolled infection
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Issa Khouri, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000065053, MDA-DM-95194, NCI-V96-1018 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002838 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia refractory chronic lymphocytic leukemia |
|
Antimetabolites Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Cyclophosphamide Fludarabine monophosphate Immunosuppressive Agents Leukemia Lymphatic Diseases |
Chronic Lymphocytic Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Antineoplastic Agents, Alkylating Fludarabine Antirheumatic Agents Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Alkylating Agents |
|
Antimetabolites Leukemia, Lymphoid Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Alkylating Agents Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Fludarabine Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Leukemia, B-Cell Antirheumatic Agents |
