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 - Full Text View

Sponsor:	German CLL Study Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00309881

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 II

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:

MedlinePlus related topics: Acute Lymphocytic Leukemia Anemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Cyclophosphamide Prednisone Vincristine Fludarabine Doxorubicin Doxorubicin hydrochloride Fludarabine monophosphate Rituximab Vincristine sulfate

U.S. FDA Resources

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

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 Not Available
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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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:	January 27, 2010
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
Fludarabine
Doxorubicin
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012