Clinical trial · Interventional
CLL-Irl Study. CTRIAL-IE (ICORG) 07-01, V7
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytogenetic analysis | Genetic | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| fluorescence in situ hybridization | Genetic | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fludarabine, Cylophosphamide and Rituximab
- interventionNames
- Biological: pegfilgrastim
- Biological: rituximab
- Drug: cyclophosphamide
- Drug: fludarabine phosphate
- Genetic: cytogenetic analysis
- Genetic: fluorescence in situ hybridization
- Genetic: gene expression analysis
- Genetic: mutation analysis
- Genetic: protein expression analysis
- Other: flow cytometry
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Complete remission rate by NCI response criteria and minimal residual disease (MRD) analysis
- timeFrame
- 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 outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAppleby 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. PMID 28925785