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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)

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
Sponsored by
German CLL Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring refractory chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kreiskrankenhaus
  • DIAKO Ev. Diakonie Krankenhaus gGmbH
  • Medizinische Universitaetsklinik I at the University of Cologne
  • Universitaetsklinikum Essen
  • Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
  • Allgemeines Krankenhaus Hagen
  • Praxis fur Innere Medizin - Hamburg
  • Asklepios Klinik St. Georg
  • Marienhospital at Ruhr University Bochum
  • Clinic for Bone Marrow Transplantation and Hematology and Oncology
  • Internistische Gemeinschaftspraxis - Kassel
  • Internistische Onkologische Praxis - Kronach
  • Klinikum der Universitaet Muenchen - Grosshadern Campus
  • Klinikum Oldenburg
  • Marienhospital Stuttgart
  • Haematologische Praxis
  • Medizinische Poliklinik, Universitaet Wuerzburg

Outcomes

Primary Outcome Measures

Rate of remission
Quality of remission

Secondary Outcome Measures

Toxicity
Progression-free survival
Overall survival

Full Information

First Posted
March 29, 2006
Last Updated
September 30, 2016
Sponsor
German CLL Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00309881
Brief Title
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)
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German CLL Study Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
refractory chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Primary Outcome Measure Information:
Title
Rate of remission
Title
Quality of remission
Secondary Outcome Measure Information:
Title
Toxicity
Title
Progression-free survival
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hallek, MD
Organizational Affiliation
Medizinische Universitaetsklinik I at the University of Cologne
Official's Role
Study Chair
Facility Information:
Facility Name
Kreiskrankenhaus
City
Bad Hersfeld
ZIP/Postal Code
36251
Country
Germany
Facility Name
DIAKO Ev. Diakonie Krankenhaus gGmbH
City
Bremen
ZIP/Postal Code
28239
Country
Germany
Facility Name
Medizinische Universitaetsklinik I at the University of Cologne
City
Cologne
ZIP/Postal Code
D-50924
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
City
Hagen
ZIP/Postal Code
58095
Country
Germany
Facility Name
Allgemeines Krankenhaus Hagen
City
Hagen
ZIP/Postal Code
D-58095
Country
Germany
Facility Name
Praxis fur Innere Medizin - Hamburg
City
Hamburg
ZIP/Postal Code
22457
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
Facility Name
Marienhospital at Ruhr University Bochum
City
Herne
ZIP/Postal Code
D-44625
Country
Germany
Facility Name
Clinic for Bone Marrow Transplantation and Hematology and Oncology
City
Idar-Oberstein
ZIP/Postal Code
D-55743
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Kassel
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Facility Name
Internistische Onkologische Praxis - Kronach
City
Kronach
ZIP/Postal Code
96317
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen - Grosshadern Campus
City
Munich
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Klinikum Oldenburg
City
Oldenburg
ZIP/Postal Code
D-26133
Country
Germany
Facility Name
Marienhospital Stuttgart
City
Stuttgart
ZIP/Postal Code
70199
Country
Germany
Facility Name
Haematologische Praxis
City
Weiden
ZIP/Postal Code
D-92637
Country
Germany
Facility Name
Medizinische Poliklinik, Universitaet Wuerzburg
City
Wuerzburg
ZIP/Postal Code
D-97070
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25196783
Citation
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.
Results Reference
result
Links:
URL
http://www.dcllsg.de/en/trial/cll2g/index.php
Description
Click here for more information about this study: CLL2G (German CLL Study Group)

Learn more about this trial

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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