CLL-Irl Study. CTRIAL-IE (ICORG) 07-01, V7

NCT00812669 | Completed Phase 2

• 3 other identifiers: CTRIAL-IE (ICORG) 07-012008-001250-40EU-20898
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 7

Brief Summary

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

Leukemia

Keywords

B-cell chronic lymphocytic leukemia; refractory chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Predictive value of immunophenotype, FISH, and hypermutation analysis in determining TTF and OS

  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.

Study Arms (1)

Fludarabine, Cylophosphamide and Rituximab

EXPERIMENTAL

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

Interventions

pegfilgrastim BIOLOGICAL

Fludarabine, Cylophosphamide and Rituximab

rituximab BIOLOGICAL

Fludarabine, Cylophosphamide and Rituximab

cyclophosphamide DRUG

Fludarabine, Cylophosphamide and Rituximab

fludarabine phosphate DRUG

Fludarabine, Cylophosphamide and Rituximab

cytogenetic analysis GENETIC

Fludarabine, Cylophosphamide and Rituximab

fluorescence in situ hybridization GENETIC

Fludarabine, Cylophosphamide and Rituximab

gene expression analysis GENETIC

Fludarabine, Cylophosphamide and Rituximab

mutation analysis GENETIC

Fludarabine, Cylophosphamide and Rituximab

protein expression analysis GENETIC

Fludarabine, Cylophosphamide and Rituximab

flow cytometry OTHER

Fludarabine, Cylophosphamide and Rituximab

laboratory biomarker analysis OTHER

Fludarabine, Cylophosphamide and Rituximab

Eligibility Criteria

• Age: 0 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (7)

Tallaght University Hospital

Dublin, Leinster, Ireland

Location

Cork University Hospital

Cork, Munster, Ireland

Location

St. James's Hospital

Dublin, 8, Ireland

Location

University College Hospital

Galway, Ireland

Location

University Hospital Limerick

Limerick, 0009, Ireland

Location

Midland Regional Hospital at Tullamore

Tullamore, Ireland

Location

Waterford Regional Hospital

Waterford, Ireland

Location

Related Publications (1)

• 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.

  PMID: 28925785 DERIVED

Related Links

• Summary of Clinical trial findings published in "Leukemia and Lymphoma".

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

pegfilgrastim; Rituximab; Cyclophosphamide; fludarabine phosphate; Cytogenetic Analysis; In Situ Hybridization, Fluorescence; Gene Expression Profiling; Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Histological Techniques; Nucleic Acid Hybridization; Cell Separation; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical

Study Officials

• Elisabeth Vandenberghe, MD

  St. James's Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: August 18, 2008
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

IE (7)