Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTRIAL-IE (ICORG) 07-01 | |||
| 2008-001250-40 | |||
| EU-20898 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive fludarabine IV over 30 minutes or orally and cyclophosphamide IV or orally on days 1-3 and pegfilgrastim subcutaneously on day 4. Starting on course 2, patients receive rituximab IV on day 1. Treatment repeats every 28 days for up to 6* courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients achieving negative minimal residual disease receive 4 courses of treatment.
Blood samples are collected periodically for biomarker analysis. Samples are analyzed for protein expression (i.e., CD38, CD20, and ZAP70) by flow cytometry; quantitative immunoglobulins, β2-microglobulin, and T-cell subsets by electrophoresis; IgVH mutation status; and cytogenetics (i.e., +12, del 13q, del 11q, and del 17p) by FISH.
After completion of study therapy, patients are followed every 6 months for 5 years and then annually until 10th January 2019.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fludarabine, Cylophosphamide and Rituximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegfilgrastim | Biological |
| ||
| rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
| Overall survival | Until 10th January 2019 |
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of chronic lymphocytic leukemia
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Vandenberghe, MD | St. James's Hospital, Ireland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tallaght University Hospital | Dublin | Leinster | Ireland | |||
| Cork University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28925785 | Derived | Appleby N, O'Brien D, Quinn FM, Smyth L, Kelly J, Parker I, Scott K, Cahill MR, Crotty G, Enright H, Hennessy B, Hodgson A, Leahy M, O'Leary H, O'Dwyer M, Hayat A, Vandenberghe EA. Risk adjusted therapy in chronic lymphocytic leukemia: a phase II cancer trials Ireland (CTRIAL-IE [ICORG 07-01]) study of fludarabine, cyclophosphamide, and rituximab therapy evaluating response adapted, abbreviated frontline therapy with FCR in non-del(17p) CLL. Leuk Lymphoma. 2018 Jun;59(6):1338-1347. doi: 10.1080/10428194.2017.1376746. Epub 2017 Sep 19. |
| Label | URL |
|---|---|
| Summary of Clinical trial findings published in "Leukemia and Lymphoma". | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
|
| cyclophosphamide | Drug |
|
| fludarabine phosphate | Drug |
|
| cytogenetic analysis | Genetic |
|
| fluorescence in situ hybridization | Genetic |
|
| gene expression analysis | Genetic |
|
| mutation analysis | Genetic |
|
| protein expression analysis | Genetic |
|
| flow cytometry | Other |
|
| laboratory biomarker analysis | Other |
|
| 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 |
| 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. |
| Cork |
| Munster |
| Ireland |
| St. James's Hospital | Dublin | 8 | Ireland |
| University College Hospital | Galway | Ireland |
| University Hospital Limerick | Limerick | 0009 | Ireland |
| Midland Regional Hospital at Tullamore | Tullamore | Ireland |
| Waterford Regional Hospital | Waterford | Ireland |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| C042382 | fludarabine phosphate |
| D020732 | Cytogenetic Analysis |
| D017404 | In Situ Hybridization, Fluorescence |
| D020869 | Gene Expression Profiling |
| D005434 | Flow Cytometry |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D017403 | In Situ Hybridization |
| D013194 | Staining and Labeling |
| D016591 | Histocytological Preparation Techniques |
| D006652 | Histological Techniques |
| D009693 | Nucleic Acid Hybridization |
| D002469 | Cell Separation |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
Not provided
Not provided