Leukemia Clinical Trial
Official title:
An Open-label Phase II Study of the Efficacy and Safety of the Combination of Fludarabine, Cyclophosphamide and Rituximab in Patients With Chronic Lymphocytic Leukaemia Who Are Newly Diagnosed, Have Relapsed or Are Resistant to First-Line Treatment
Verified date | April 2023 |
Source | Cancer Trials Ireland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine together with cyclophosphamide and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works in treating patients with chronic lymphocytic leukemia.
Status | Completed |
Enrollment | 52 |
Est. completion date | November 21, 2019 |
Est. primary completion date | November 21, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years to 64 Years |
Eligibility | DISEASE CHARACTERISTICS: - Diagnosis of chronic lymphocytic leukemia - Stage I-IV disease (Binet stage progressive A, B, C) - CD5 and CD23 positive - Untreated OR relapsed/resistant disease after combination chemotherapy or rituximab - No 17p deletion PATIENT CHARACTERISTICS: - WHO performance status 0-2 - Life expectancy > 1 year - Creatinine clearance = 50 mL/min - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other concurrent malignancy except for noninvasive cervical cancer or localized nonmelanomatous skin cancer - No history of anaphylaxis to mouse-derived humanized monoclonal antibody - No other severe concurrent (e.g., cardiac or pulmonary) diseases or mental disorders that could interfere with ability to participate in the study PRIOR CONCURRENT THERAPY: - See Disease Characteristics |
Country | Name | City | State |
---|---|---|---|
Ireland | Cork University Hospital | Cork | Munster |
Ireland | St. James's Hospital | Dublin | |
Ireland | Tallaght University Hospital | Dublin | Leinster |
Ireland | University College Hospital | Galway | |
Ireland | University Hospital Limerick | Limerick | |
Ireland | Midland Regional Hospital at Tullamore | Tullamore | |
Ireland | Waterford Regional Hospital | Waterford |
Lead Sponsor | Collaborator |
---|---|
Cancer Trials Ireland |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete remission rate by NCI response criteria and minimal residual disease (MRD) analysis | A formal assessment of response by NCI Criteria (Appendix 3) with the addition of assessment of minimal residual disease in the marrow and if relevant assessment of bulky disease by CT scanning will be made after 4 +/-6 courses of therapy. | ||
Secondary | Time to treatment failure (TFF) | A clinical assessment of response will be made after 4 courses of therapy, Patients with evidence of progressive disease will stop therapy and will be deemed to have failed treatment. | ||
Secondary | Overall survival | Until 10th January 2019 | ||
Secondary | Predictive value of immunophenotype, FISH, and hypermutation analysis in determining TTF and OS | Timing and type of response assessment During chemotherapy. A clinical assessment of response will be made after 4 courses of therapy. Patients with evidence of progressive disease will stop therapy and will be deemed to have failed treatment. A formal assessment of response by NCI Criteria (Appendix 3) with the addition of assessment of minimal residual disease in the marrow and if relevant assessment of bulky disease by CT scanning will be made after 4 +/-6 courses of therapy. Following chemotherapy. Disease assessment after the end of therapy will involve a history(recording B-symptoms), complete physical examination, full blood count and blood MRD analysis every 6 months for 5 years and then annually until 10th of January 2019 or until disease progression. |
See description | |
Secondary | Acute and chronic toxicity as assessed by NCI criteria | A formal assessment of response by NCI Criteria (Appendix 3) with the addition of assessment of minimal residual disease in the marrow and if relevant assessment of bulky disease by CT scanning will be made after 4 +/-6 courses of therapy. |
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