Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia That Did Not Respond to Fludarabine (Closed to Entry as of 10/2006), Chronic Lymphocytic Leukemia With Autoimmune Hemolytic Anemia, or Richter Transformation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00309881
First received: March 29, 2006
Last updated: August 23, 2013
Last verified: January 2010
  Purpose

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
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 National Cancer Institute (NCI):

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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00309881

Locations
Germany
Kreiskrankenhaus Recruiting
Bad Hersfeld, Germany, 36251
Contact: Contact Person    49-6621-88-0      
DIAKO Ev. Diakonie Krankenhaus gGmbH Recruiting
Bremen, Germany, 28239
Contact: Contact Person    49-421-6102      
Medizinische Universitaetsklinik I at the University of Cologne Recruiting
Cologne, Germany, D-50924
Contact: Contact Person    49 221 4784400      
Universitaetsklinikum Essen Recruiting
Essen, Germany, D-45122
Contact: Contact Person    49-201-723-2321      
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie Recruiting
Giessen, Germany, 35392
Contact: Contact Person    49-641-94-46-10      
Allgemeines Krankenhaus Hagen Recruiting
Hagen, Germany, D-58095
Contact: Contact Person    49-2331-2010      
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH Recruiting
Hagen, Germany, 58095
Contact: Contact Person    49-2331-129-250      
Praxis fur Innere Medizin - Hamburg Recruiting
Hamburg, Germany, 22457
Contact: Contact Person         
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, D-20099
Contact: Contact Person    49-40-2488-2126      
Marienhospital at Ruhr University Bochum Recruiting
Herne, Germany, D-44625
Contact: Contact Person    49-2323-499-1661      
Clinic for Bone Marrow Transplantation and Hematology and Oncology Recruiting
Idar-Oberstein, Germany, D-55743
Contact: Contact Person    49-6781-66-1580      
Internistische Gemeinschaftspraxis - Kassel Recruiting
Kassel, Germany, 34117
Contact: Contact Person    49-561-739-3372      
Internistische Onkologische Praxis - Kronach Recruiting
Kronach, Germany, 96317
Contact: Contact Person    49-9261-624-8161      
Klinikum der Universitaet Muenchen - Grosshadern Campus Recruiting
Munich, Germany, D-81377
Contact: Contact Person    49-89-7095-2551      
Klinikum Oldenburg Recruiting
Oldenburg, Germany, D-26133
Contact: Contact Person    49-441-403-2611      
Marienhospital Stuttgart Recruiting
Stuttgart, Germany, 70199
Contact: Contact Person    49-711-6489-8101      
Haematologische Praxis Recruiting
Weiden, Germany, D-92637
Contact: Contact Person    49-961-320-60      
Medizinische Poliklinik, Universitaet Wuerzburg Recruiting
Wuerzburg, Germany, D-97070
Contact: Contact Person    49-931-310      
Sponsors and Collaborators
German CLL Study Group
Investigators
Study Chair: Michael Hallek, MD Medizinische Universitaetsklinik I at the University of Cologne
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00309881     History of Changes
Other Study ID Numbers: CDR0000455040, GCLLSG-CLL2G, EU-20549, GCLLSG-423, MEDAC-GCLLSG-CLL2G
Study First Received: March 29, 2006
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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:
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Anemia
Hematologic Diseases
Autoimmune Diseases
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Cyclophosphamide
Rituximab
Liposomal doxorubicin
Fludarabine
Doxorubicin
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on August 21, 2014