⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for 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)

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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 ID: NCT00309881

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Kreiskrankenhaus, Bad Hersfeld, , Germany

DIAKO Ev. Diakonie Krankenhaus gGmbH, Bremen, , Germany

Medizinische Universitaetsklinik I at the University of Cologne, Cologne, , Germany

Universitaetsklinikum Essen, Essen, , Germany

Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie, Giessen, , Germany

St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH, Hagen, , Germany

Allgemeines Krankenhaus Hagen, Hagen, , Germany

Praxis fur Innere Medizin - Hamburg, Hamburg, , Germany

Asklepios Klinik St. Georg, Hamburg, , Germany

Marienhospital at Ruhr University Bochum, Herne, , Germany

Clinic for Bone Marrow Transplantation and Hematology and Oncology, Idar-Oberstein, , Germany

Internistische Gemeinschaftspraxis - Kassel, Kassel, , Germany

Internistische Onkologische Praxis - Kronach, Kronach, , Germany

Klinikum der Universitaet Muenchen - Grosshadern Campus, Munich, , Germany

Klinikum Oldenburg, Oldenburg, , Germany

Marienhospital Stuttgart, Stuttgart, , Germany

Haematologische Praxis, Weiden, , Germany

Medizinische Poliklinik, Universitaet Wuerzburg, Wuerzburg, , Germany

Contact Details

Name: Michael Hallek, MD

Affiliation: Medizinische Universitaetsklinik I at the University of Cologne

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: