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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)

This study has been completed.
Information provided by (Responsible Party):
German CLL Study Group Identifier:
First received: March 29, 2006
Last updated: September 30, 2016
Last verified: September 2016

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.

Condition Intervention Phase
Chronic Lymphocytic Leukemia
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by German CLL Study Group:

Primary Outcome Measures:
  • Rate of remission [ Designated as safety issue: No ]
  • Quality of remission [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: April 2003
Study Completion Date: March 2011
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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


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


  • No more than 4 prior chemotherapy regimens
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00309881

Bad Hersfeld, Germany, 36251
DIAKO Ev. Diakonie Krankenhaus gGmbH
Bremen, Germany, 28239
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, Germany, D-50924
Universitaetsklinikum Essen
Essen, Germany, D-45122
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
Giessen, Germany, 35392
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
Hagen, Germany, 58095
Allgemeines Krankenhaus Hagen
Hagen, Germany, D-58095
Praxis fur Innere Medizin - Hamburg
Hamburg, Germany, 22457
Asklepios Klinik St. Georg
Hamburg, Germany, D-20099
Marienhospital at Ruhr University Bochum
Herne, Germany, D-44625
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, Germany, D-55743
Internistische Gemeinschaftspraxis - Kassel
Kassel, Germany, 34117
Internistische Onkologische Praxis - Kronach
Kronach, Germany, 96317
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, Germany, D-81377
Klinikum Oldenburg
Oldenburg, Germany, D-26133
Marienhospital Stuttgart
Stuttgart, Germany, 70199
Haematologische Praxis
Weiden, Germany, D-92637
Medizinische Poliklinik, Universitaet Wuerzburg
Wuerzburg, Germany, D-97070
Sponsors and Collaborators
German CLL Study Group
Study Chair: Michael Hallek, MD Medizinische Universitaetsklinik I at the University of Cologne
  More Information

Additional Information:
Responsible Party: German CLL Study Group Identifier: NCT00309881     History of Changes
Other Study ID Numbers: CLL2G  EU-20549  GCLLSG-423  MEDAC-GCLLSG-CLL2G 
Study First Received: March 29, 2006
Last Updated: September 30, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by German CLL Study Group:
refractory chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Hematologic Diseases
Autoimmune Diseases
Fludarabine phosphate
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016