Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia (CLL) That Did Not Respond to Fludarabine, CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT)

NCT ID: NCT00309881

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2011-03-31

Brief Summary

RATIONALE: Drugs used in chemotherapy 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 more than one drug (combination chemotherapy) together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with chronic lymphocytic leukemia (CLL) that has not responded to fludarabine (closed to entry as of 10/2006), CLL with autoimmune hemolytic anemia, or Richter transformation.

Detailed Description

OBJECTIVES:

Primary

• Determine the efficacy, in terms of the rate and quality of remission, of chemotherapy comprising cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and rituximab (CHOP-R) in patients with fludarabine-refractory chronic lymphocytic leukemia (CLL) (closed to accrual as of 10/2006), CLL with autoimmune hemolytic anemia, or Richter transformation.
• Determine the incidence of infection in patients on CHOP-R regimen.

Secondary

• Determine the toxicity of this regimen in these patients
• Determine the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a prospective, multicenter study. Patients are stratified according to disease (chronic lymphocytic leukemia (CLL) (closed to accrual as of 10/2006) vs CLL with autoimmune hemolytic anemia vs Richter transformation).

Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients also receive rituximab IV on day 1 of the second course and each subsequent course. Treatment repeats every 21 days for up to 6 (for patients with CLL) or 8 (for patients with Richter's transformation) courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Primary Study Purpose: TREATMENT

Interventions

rituximab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Confirmed diagnosis of previously treated chronic lymphocytic leukemia (CLL) meeting the following criteria:

• Binet stage B (Rai stages I and II) or Binet stage C (Rai stages III and IV) disease
• Rapid disease progression, symptomatic enlarged lymph nodes, or severe B-cell symptoms
• CLL with autoimmune hemolytic anemia allowed
• Richter transformation allowed

PATIENT CHARACTERISTICS:

• Life expectancy > 3 months
• ECOG performance status 0-3
• No severe organ dysfunction
• No other prior or concurrent neoplasms

PRIOR CONCURRENT THERAPY:

• No more than 4 prior chemotherapy regimens

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German CLL Study Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Hallek, MD

Role: STUDY_CHAIR

Medizinische Universitaetsklinik I at the University of Cologne

Locations

Kreiskrankenhaus

Bad Hersfeld, , Germany

DIAKO Ev. Diakonie Krankenhaus gGmbH

Bremen, , Germany

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, , Germany

Universitaetsklinikum Essen

Essen, , Germany

Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

Giessen, , Germany

St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

Hagen, , Germany

Allgemeines Krankenhaus Hagen

Hagen, , Germany

Praxis fur Innere Medizin - Hamburg

Hamburg, , Germany

Asklepios Klinik St. Georg

Hamburg, , Germany

Marienhospital at Ruhr University Bochum

Herne, , Germany

Clinic for Bone Marrow Transplantation and Hematology and Oncology

Idar-Oberstein, , Germany

Internistische Gemeinschaftspraxis - Kassel

Kassel, , Germany

Internistische Onkologische Praxis - Kronach

Kronach, , Germany

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, , Germany

Klinikum Oldenburg

Oldenburg, , Germany

Marienhospital Stuttgart

Stuttgart, , Germany

Haematologische Praxis

Weiden, , Germany

Medizinische Poliklinik, Universitaet Wuerzburg

Würzburg, , Germany

Countries

Germany

References

Langerbeins P, Busch R, Anheier N, Durig J, Bergmann M, Goebeler ME, Hurtz HJ, Stauch MB, Stilgenbauer S, Dohner H, Fink AM, Cramer P, Fischer K, Wendtner CM, Hallek M, Eichhorst B. Poor efficacy and tolerability of R-CHOP in relapsed/refractory chronic lymphocytic leukemia and Richter transformation. Am J Hematol. 2014 Dec;89(12):E239-43. doi: 10.1002/ajh.23841. Epub 2014 Sep 26.

Reference Type: RESULT

PMID: 25196783 (View on PubMed)

Other Identifiers

EU-20549

Identifier Type: -

Identifier Source: secondary_id

GCLLSG-423

Identifier Type: -

Identifier Source: secondary_id

MEDAC-GCLLSG-CLL2G

Identifier Type: -

Identifier Source: secondary_id

CLL2G

Identifier Type: -

Identifier Source: org_study_id