Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Leukemia Research Fund Medical Research Council |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004218 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works compared to fludarabine and cyclophosphamide or fludarabine alone in treating patients with newly diagnosed chronic lymphocytic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: chlorambucil Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: fludarabine phosphate Drug: prednisolone Drug: vincristine sulfate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Chronic Lymphocytic Leukemia Trial 4: A Randomized Comparison of Chlorambucil, Fludarabine and Fludarabine Plus Cyclophosphamide |
Study Start Date: | October 1999 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients enter one of three treatment arms in the first randomization. Depending on response, some patients may also participate in a second randomization to one of two treatment arms.
First randomization:
Patients who experience progressive disease or relapse within 1 year after treatment proceed to a second randomization.
Second randomization:
Quality of life is assessed prior to initial therapy; at 3, 6, and 12 months; and then annually thereafter.
Patients are followed annually for survival.
PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study within 6-7 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of B-cell chronic lymphocytic leukemia (CLL) requiring therapy and meeting the following criteria:
Stage 0 or I progressive disease indicated by at least one of the following:
Constitutional symptoms caused by disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Daniel Catovsky, MD | Royal Marsden - London |
Study Chair: | Daniel Catovsky, MD | Royal Marsden - London |
Study ID Numbers: | CDR0000067454, LRF-CLL4, LRG-MRC-LEUK-CLL4, EU-99030, MRC-LEUK-CLL4, EUDRACT-58585610, ISRCTN58585610 |
Study First Received: | January 28, 2000 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00004218 History of Changes |
Health Authority: | United States: Federal Government |
stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia B-cell chronic lymphocytic leukemia stage 0 chronic lymphocytic leukemia |
Antimetabolites Anti-Inflammatory Agents Leukemia, Lymphoid Immunologic Factors Methylprednisolone Hormone Antagonists Chlorambucil Hormones, Hormone Substitutes, and Hormone Antagonists Prednisolone acetate Cyclophosphamide Hormones Anti-Bacterial Agents Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic |
Alkylating Agents Methylprednisolone Hemisuccinate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Methylprednisolone acetate Vincristine Antimitotic Agents Fludarabine monophosphate Glucocorticoids Immunosuppressive Agents Doxorubicin Lymphatic Diseases Chronic Lymphocytic Leukemia Tubulin Modulators Prednisolone |
Antimetabolites Anti-Inflammatory Agents Leukemia, Lymphoid Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Chlorambucil Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Leukemia Leukemia, Lymphocytic, Chronic, B-Cell |
Therapeutic Uses Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Vincristine Antimitotic Agents Fludarabine monophosphate Glucocorticoids Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases |