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)

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

CHOP Plus Rituximab (CHOP-R) in Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL) or CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309881
• Other study ID #: CLL2G
• Secondary ID: EU-20549GCLLSG-4
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2006
• Last updated: September 30, 2016
• Start date: April 2003
• Est. completion date: March 2011

Study information

• Verified date: September 2016
• Source: German CLL Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2011
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Biological:
• rituximab

Drug:
• cyclophosphamide

• doxorubicin hydrochloride

• prednisone

• vincristine sulfate

Locations

Country	Name	City	State
Germany	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	Allgemeines Krankenhaus Hagen	Hagen
Germany	St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH	Hagen
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Praxis fur Innere Medizin - Hamburg	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	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
German CLL Study Group

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Langerbeins P, Busch R, Anheier N, Dürig J, Bergmann M, Goebeler ME, Hurtz HJ, Stauch MB, Stilgenbauer S, Döhner H, Fink AM, Cramer P, Fischer K, Wendtner CM, Hallek M, Eichhorst B. Poor efficacy and tolerability of R-CHOP in relapsed/refractory chronic l — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of remission			No
Primary	Quality of remission			No
Secondary	Toxicity			Yes
Secondary	Progression-free survival			No
Secondary	Overall survival			No

External Links

•   Click here for more information about this study: CLL2G (German CLL Study Group)