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
Recruitment status was Recruiting
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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) |
- Rate of remission [ Designated as safety issue: No ]
- Quality of remission [ Designated as safety issue: No ]
- 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 |
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 |
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| 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 | |
| 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: | 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 May 23, 2013