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)

September 30, 2016 updated by: German CLL Study Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of remission
Quality of remission

Secondary Outcome Measures

Outcome Measure
Toxicity
Progression-free survival
Overall survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German CLL Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 29, 2006

First Submitted That Met QC Criteria

March 29, 2006

First Posted (Estimate)

April 3, 2006

Study Record Updates

Last Update Posted (Estimate)

October 3, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLL2G
  • EU-20549
  • GCLLSG-423
  • MEDAC-GCLLSG-CLL2G

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Lymphocytic Leukemia

Clinical Trials on cyclophosphamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe