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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)

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ClinicalTrials.gov Identifier: NCT00309881
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : October 3, 2016
Information provided by (Responsible Party):
German CLL Study Group

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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)
Study Start Date : April 2003
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2011

Primary Outcome Measures :
  1. Rate of remission
  2. Quality of remission

Secondary Outcome Measures :
  1. Toxicity
  2. Progression-free survival
  3. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309881

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Sponsors and Collaborators
German CLL Study Group
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Study Chair: Michael Hallek, MD Medizinische Universitaetsklinik I at the University of Cologne
Additional Information:
Publications of Results:
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Responsible Party: German CLL Study Group
ClinicalTrials.gov Identifier: NCT00309881    
Other Study ID Numbers: CLL2G
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
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:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Neoplasms by Histologic Type
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Autoimmune Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists