Combination Chemotherapy With or Without Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2011-03-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and mitoxantrone, 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 combination chemotherapy together with rituximab may kill more cancer cells. It is not yet known whether giving combination chemotherapy together with rituximab is more effective than combination chemotherapy alone in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase II trial is studying how well giving combination chemotherapy with or without rituximab works in treating patients with previously treated chronic lymphocytic leukemia.

Detailed Description

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OBJECTIVES:

Primary

* Assess the efficacy and safety of fludarabine, cyclophosphamide, and mitoxantrone hydrochloride with or without rituximab in patients with previously treated chronic lymphocytic leukemia.
* Determine the overall response rate, defined as complete or partial remission, in these patients.

Secondary

* Determine the proportion of patients with undetectable minimal residual disease.
* Determine the 2-year progression-free survival of these patients.
* Determine the 2-year overall survival of these patients.
* Determine the toxicity of this regimen.

OUTLINE: This is a randomized, controlled, open-label, parallel group, multicenter study. Patients are stratified according to prior treatment with fludarabine (refractory vs not refractory or naive). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral fludarabine\* and oral cyclophosphamide\* on days 1-5 and mitoxantrone hydrochloride IV on day 1.
* Arm II: Patients receive fludarabine\*, cyclophosphamide\*, and mitoxantrone hydrochloride as in arm I. Patients also receive rituximab IV on day 1.

NOTE: \*If the oral regimen is not tolerated, patients may receive fludarabine IV and cyclophosphamide IV on days 1-3.

Treatment in both arms repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.

Conditions

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Leukemia

Keywords

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refractory chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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rituximab

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

fludarabine phosphate

Intervention Type DRUG

mitoxantrone hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of chronic lymphocytic leukemia requiring therapy
* Previously treated with ≥ 1 chemotherapeutic regimen

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Life expectancy ≥ 12 weeks
* Creatinine clearance ≥ 30 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile female patients must use effective contraception for 4 weeks before, during, and for 6 months after completion of study treatment
* Fertile male patients must use effective contraception during and for 6 months after completion of study treatment
* No history of anaphylaxis after exposure to rat or mouse-derived complementary-determining region (CDR)-grafted humanized monoclonal antibodies
* No toxicity attributable to purine analogues (e.g., autoimmune hemolytic anemia, neurological toxicity, or allergy)
* No active infection
* No other severe (particularly cardiac or pulmonary) diseases or mental disorders that would preclude study participation

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior fludarabine (or other purine analogues) combined with cyclophosphamide and mitoxantrone hydrochloride
* No prior rituximab, either alone or in combination with chemotherapy

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Peter Hillmen, MD

Role: STUDY_CHAIR

Leeds General Infirmary

Locations

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Birmingham Heartlands Hospital

Birmingham, England, United Kingdom

Site Status

Blackpool Victoria Hospital

Blackpool, England, United Kingdom

Site Status

Kent and Canterbury Hospital

Canterbury, England, United Kingdom

Site Status

St Helier Hospital

Carshalton, England, United Kingdom

Site Status

Darent Valley Hospital

Dartford Kent, England, United Kingdom

Site Status

Medway Maritime Hospital

Gillingham Kent, England, United Kingdom

Site Status

Leeds General Infirmary at Leeds Teaching Hospital NHS Trust

Leeds, England, United Kingdom

Site Status

Leicester Royal Infirmary

Leicester, England, United Kingdom

Site Status

Royal Liverpool and Broadgreen Hospitals NHS Trust

Liverpool, England, United Kingdom

Site Status

Maidstone Hospital

Maidstone, England, United Kingdom

Site Status

Christie Hospital NHS Trust

Manchester, England, United Kingdom

Site Status

Royal Cornwall Hospital

Truro, Cornwall, England, United Kingdom

Site Status

Kent and Sussex Hospital

Tunbridge Wells, Kent, England, United Kingdom

Site Status

Wishaw General Hospital

Wishaw, England, United Kingdom

Site Status

Monklands General Hospital

Airdrie, Scotland, United Kingdom

Site Status

University Hospital of Wales

Cardiff, Wales, United Kingdom

Site Status

Countries

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United Kingdom

References

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Hillmen P, Cohen DR, Cocks K, Pettitt A, Sayala HA, Rawstron AC, Kennedy DB, Fegan C, Milligan DW, Radford J, Mercieca J, Dearden C, Ezekwisili R, Smith AF, Brown J, Booth GA, Varghese AM, Pocock C; NCRI CLL Sub-Group. A randomized phase II trial of fludarabine, cyclophosphamide and mitoxantrone (FCM) with or without rituximab in previously treated chronic lymphocytic leukaemia. Br J Haematol. 2011 Mar;152(5):570-8. doi: 10.1111/j.1365-2141.2010.08317.x. Epub 2011 Jan 14.

Reference Type RESULT

PMID: 21231927 (View on PubMed)