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LeukemiaPhase 3NCT00564512

Fludarabine, Cyclophosphamide, and Rituximab or Alemtuzumab in Treating CLL2007 CLL 2007 FMP

A Phase 3 study testing Campath, rituximab and cyclophosphamide in people with Leukemia, run by French Innovative Leukemia Organisation at 1 site in France.

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 kill cancer cells or stop them from growing. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Leukemia
What is being tested?
Campath, rituximab and cyclophosphamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
1 siteFrance
Study dates
Nov 2007to Jul 2013
Phase
Phase 3
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL), meeting the following criteria:
  • Binet classification stages B or C
  • Del 17 p (FISH) negative (< 10 % positives cores)
  • Matutes score 4 or 5
  • Exclusion Transformation to aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin lymphoma, or prolymphocytic leukemia)
  • PATIENT CHARACTERISTICS:
  • No prior chemotherapy, radiotherapy, or immunotherapy for CLL
  • Corticosteroids within the past month allowed

Who cannot join

  • Life expectancy < 6 months
  • Creatinine clearance < 60 mL/min
  • Total bilirubin > 2 x upper limit of normal (ULN)
  • Gamma glutamyltransferase or transaminase levels > 2 x ULN
  • Cumulative illness rating scale > 6
  • HIV seropositivity
Show all 27Show fewer
  • Hepatitis B or C seropositivity (unless clearly due to vaccination)
  • Clinically significant autoimmune anemia
  • Active bacterial, viral, or fungal infection
  • Active second malignancy currently requiring treatment (except basal cell carcinoma or in situ endometrial carcinoma) and/or less than 5 years complete remission after breast cancer
  • Any severe comorbid conditions including, but not limited to, any of the following:
  • Class III or IV heart failure
  • Recent myocardial infarction
  • Unstable angina
  • Ventricular tachyarrhythmias requiring ongoing treatment
  • Severe chronic obstructive pulmonary disease with hypoxemia
  • Uncontrolled diabetes mellitus
  • Uncontrolled hypertension
  • Concomitant disease requiring prolonged use of corticosteroids (> 1 month)
  • Known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs
  • Contraindication to the use of rituximab or alemtuzumab according to Summary of Product Characteristics
  • Any coexisting medical or psychological condition that would preclude participation in the required study procedures
  • Any mental deficiency preventing proper understanding of the requirements of treatment
  • Person under law control
  • Pregnant or breastfeeding women
  • Fertile patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study
  • PRIOR CONCURRENT THERAPY:

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Henri Becquerel

    Rouen, 76038

Other trials in France

About this study

Official title: Randomized Phase-III Trial Comparing Fludarabine and Cyclophosphamide Plus Rituximab (FCR) to FC and MabCampath (FCCam) for Previously Untreated Fit Patients With Chronic Lymphocytic Leukemia (CLL)

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to kill cancer cells or stop them from growing. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. It is not yet known whether giving fludarabine and cyclophosphamide together with rituximab is more effective than giving fludarabine and cyclophosphamide together with alemtuzumab in treating B-cell chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works as first-line therapy compared with giving fludarabine together with cyclophosphamide and alemtuzumab in treating patients with B-cell chronic lymphocytic leukemia.

Read the detailed description

OBJECTIVES:

Primary

  • To compare 36-month progression-free survival in patients with Binet stage B or C B-cell chronic lymphocytic leukemia treated with first-line therapy comprising fludarabine phosphate and cyclophosphamide and either rituximab or alemtuzumab.

Secondary

  • To compare the disease-free survival, event-free survival, and overall survival of patients treated with these regimens.
  • To compare time to next treatment in patients treated with these regimens.
  • To compare the overall response rate (complete response [CR] and partial response [PR]) in patients treated with these regimens.
  • To compare the rate of phenotypic and molecular response in patients treated with these regimens.
  • To compare the duration of phenotypic, molecular, complete and partial responses in patients treated with these regimens.
  • To compare the response rates and survival times in biological subgroups.
  • To compare the rates of treatment-related adverse effects in patients treated with these regimens.
  • To compare the quality of life of patients treated with these regimens.
  • Minimal residual disease study.

OUTLINE: This is a multicenter study. Patients are stratified according to Ig mutational status and cytogenetic abnormalities. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive rituximab IV on day 1 and fludarabine phosphate and cyclophosphamide IV or orally on days 2-4 of course 1. Beginning in course 2 and for all subsequent courses, patients receive rituximab IV on day 1 and fludarabine phosphate and cyclophosphamide IV or orally on days 1-3.
  • Arm II: Patients receive alemtuzumab subcutaneously, oral fludarabine phosphate, and oral cyclophosphamide on days 1-3.

In both arms, treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months.

Conditions
Leukemia
Being tested
Campath, rituximab, cyclophosphamide, fludarabine
Keywords
B-cell 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.

  • CampathBiological

    Also called Alemtuzumab

    Fludarabine-Cyclophosphamide-Campath (FCCam)

  • rituximabBiological

    Also called Mabthera®

    Fludarabine-Cyclophosphamide-Rituximab (FCR)

  • cyclophosphamideDrug

    Also called Endoxan®

    Fludarabine-Cyclophosphamide-Campath (FCCAM) Fludarabine-Cyclophosphamide-Rituximab (FCR)

  • fludarabineDrug

    Also called Fludara®

    Fludarabine-Cyclophosphamide-Campath (FCCAM) Fludarabine-Cyclophosphamide-Rituximab (FCR)

Study groups in NCT00564512
Study groupRoleWhat they receive
FCCAMExperimentalFludarabine-Cyclophosphamide-Campath (FCCam) Oral Fludarabine: 40 mg/m2 per os, D1 to D3 Oral Cyclophosphamide: 250 mg/m2/day as one dose at noon, D1 to D3 Campath®: 30 mg sc, D1 to D3 without dose escalation
Receives: Biological: rituximab; Drug: cyclophosphamide; Drug: fludarabine
FCRActive comparatorFludarabine-Cyclophosphamide-Rituximab (FCR) First course: Rituximab 375 mg/m2 on D1. D2 to D4: oral Fludarabine: 40 mg/m2/day as a single morning dose oral Cyclophosphamide: 250 mg/m2/day as a single dose at noon Subsequent courses (2 to 6) Rituximab 500 mg/m2 on D1 D1 to D3: oral Fludarabine: 40 mg/m2/day as a single morning dose oral Cyclophosphamide: 250 mg/m2/day as a single dose at noon
Receives: Biological: Campath; Drug: cyclophosphamide

What is being measured

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

  1. Progression-free survival at 36 months

    Measured: 36 months follow up

Secondary outcomes (8)

  1. Disease-free survival

    Measured: 36 months follow up

  2. Event-free survival

    Measured: 36 months follow up

  3. Overall survival

    Measured: 36 months follow up

  4. Time to next treatment

    Measured: 36 months follow up

  5. Overall response rate (complete response [CR] and partial response [PR])

    Measured: 36 months follow up

  6. Duration of phenotypic, molecular, NCI complete and partial responses

    Measured: 36 months follow up

  7. Response rates and survival times in biological subgroups

    Measured: 36 months follow up

  8. Treatment-related adverse effects

    Measured: 36 months follow up

Timeline

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

  1. First posted28 Nov 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJan 2009
  4. Study completionJul 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00564512
Sponsor's protocol ID
CDR0000577580
Other IDs
CLL-2007-FMP
Status last verified
Apr 2009
First submitted
27 Nov 2007
Last updated
25 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Grgurevic S, Montilla-Perez P, Bradbury A, Gilhodes J, Queille S, Pelofy S, Bancaud A, Filleron T, Ysebaert L, Recher C, Laurent G, Fournie JJ, Cazaux C, Quillet-Mary A, Hoffmann JS. DNA polymerase nu gene expression influences fludarabine resistance in chronic lymphocytic leukemia independently of p53 status. Haematologica. 2018 Jun;103(6):1038-1046. doi: 10.3324/haematol.2017.174243. Epub 2018 Mar 22.

    PubMed 29567785

  • Lepretre S, Aurran T, Mahe B, Cazin B, Tournilhac O, Maisonneuve H, Casasnovas O, Delmer A, Leblond V, Royer B, Corront B, Chevret S, Delepine R, Vaudaux S, Van Den Neste E, Bene MC, Letestu R, Cymbalista F, Feugier P. Excess mortality after treatment with fludarabine and cyclophosphamide in combination with alemtuzumab in previously untreated patients with chronic lymphocytic leukemia in a randomized phase 3 trial. Blood. 2012 May 31;119(22):5104-10. doi: 10.1182/blood-2011-07-365437. Epub 2012 Feb 14.

    PubMed 22337714

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Campath, rituximab and cyclophosphamide in people with Leukemia, run by French Innovative Leukemia Organisation at 1 site in France.

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

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. 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 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Progression-free survival at 36 months (time frame: 36 months follow up). 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 NCT00564512, which also lists 2 linked publications.

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 25 Jul 2013.

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