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)

NCT00309881 | Completed Phase 2

• 4 other identifiers: CLL2GEU-20549GCLLSG-423MEDAC-GCLLSG-CLL2G
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 18

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Rate of remission

• Quality of remission

Secondary Outcomes (3)

• Toxicity

• Progression-free survival

• Overall survival

Interventions

rituximab BIOLOGICAL

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

prednisone DRUG

vincristine sulfate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• German CLL Study Group: lead

Study Sites (18)

Kreiskrankenhaus

Bad Hersfeld, 36251, Germany

Location

DIAKO Ev. Diakonie Krankenhaus gGmbH

Bremen, 28239, Germany

Location

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, D-50924, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

Giessen, 35392, Germany

Location

St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

Hagen, 58095, Germany

Location

Allgemeines Krankenhaus Hagen

Hagen, D-58095, Germany

Location

Praxis fur Innere Medizin - Hamburg

Hamburg, 22457, Germany

Location

Asklepios Klinik St. Georg

Hamburg, D-20099, Germany

Location

Marienhospital at Ruhr University Bochum

Herne, D-44625, Germany

Location

Clinic for Bone Marrow Transplantation and Hematology and Oncology

Idar-Oberstein, D-55743, Germany

Location

Internistische Gemeinschaftspraxis - Kassel

Kassel, 34117, Germany

Location

Internistische Onkologische Praxis - Kronach

Kronach, 96317, Germany

Location

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

Location

Klinikum Oldenburg

Oldenburg, D-26133, Germany

Location

Marienhospital Stuttgart

Stuttgart, 70199, Germany

Location

Haematologische Praxis

Weiden, D-92637, Germany

Location

Medizinische Poliklinik, Universitaet Wuerzburg

Würzburg, D-97070, Germany

Location

Related Publications (1)

• 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.

  PMID: 25196783 RESULT

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Michael Hallek, MD

  Medizinische Universitaetsklinik I at the University of Cologne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2006
• First Posted: April 3, 2006
• Study Start: April 1, 2003
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2011
• Last Updated: October 3, 2016

Record last verified: 2016-09

Locations

DE (18)