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LeukemiaPhase 2NCT00812669

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

A Phase 2 study testing pegfilgrastim, rituximab and cyclophosphamide in people with Leukemia, run by Cancer Trials Ireland at 7 sites in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 to 64 years
Conditions the study is for
Leukemia
What is being tested?
pegfilgrastim, rituximab and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
7 sitesIreland
Study dates
18 Aug 2008to 21 Nov 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 64 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Ireland7 sites

  • Cork University Hospital

    Cork, Munster

  • Tallaght University Hospital

    Dublin, Leinster

  • St. James's Hospital

    Dublin, 8

  • University College Hospital

    Galway

  • University Hospital Limerick

    Limerick, 0009

  • Midland Regional Hospital at Tullamore

    Tullamore

  • Waterford Regional Hospital

    Waterford

Other trials in Ireland

About this study

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

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.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate the efficacy, in terms of complete remission rate, of fludarabine phosphate, cyclophosphamide, and rituximab in patients with chronic lymphocytic leukemia.

Secondary

  • Determine the time to treatment failure (TTF) in these patients.
  • Determine the overall survival of these patients until 10th January 2019.
  • Assess the predictive value of immunophenotype, hypermutation analysis, and FISH in determining TTF and OS in these patients.
  • Determine the safety profile of this regimen.

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.

Conditions
Leukemia
Being tested
pegfilgrastim, rituximab, cyclophosphamide, fludarabine phosphate, cytogenetic analysis
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
Medical subject headings
Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00812669
Study groupRoleWhat they receive
Fludarabine, Cylophosphamide and RituximabExperimentalNot described
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete remission rate by NCI response criteria and minimal residual disease (MRD) analysis

    Measured: 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)

  1. Time to treatment failure (TFF)

    Measured: 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.

  2. Overall survival

    Measured: Until 10th January 2019

  3. 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.

    Measured: See description

  4. Acute and chronic toxicity as assessed by NCI criteria

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2008 (estimated)
  2. Study start18 Aug 2008
  3. Primary completion21 Nov 2019
  4. Study completion21 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00812669
Sponsor's protocol ID
CTRIAL-IE (ICORG) 07-01
Other IDs
CTRIAL-IE (ICORG) 07-01, 2008-001250-40, EU-20898, 2008
Status last verified
Jul 2025
First submitted
19 Dec 2008
Last updated
8 Jul 2025
Results posted
No

Publications

  • 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.

    PubMed 28925785

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pegfilgrastim, rituximab and cyclophosphamide in people with Leukemia, run by Cancer Trials Ireland at 7 sites in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission rate by NCI response criteria and minimal residual disease (MRD) analysis (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00812669, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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