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| ID | Type | Description | Link |
|---|---|---|---|
| EU-20549 | |||
| GCLLSG-423 | |||
| MEDAC-GCLLSG-CLL2G |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological | |||
| cyclophosphamide | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| prednisone | Drug | |||
| vincristine sulfate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of remission | ||
| Quality of remission |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | ||
| Progression-free survival | ||
| Overall survival |
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DISEASE CHARACTERISTICS:
Confirmed diagnosis of previously treated chronic lymphocytic leukemia (CLL) meeting the following criteria:
CLL with autoimmune hemolytic anemia allowed
Richter transformation allowed
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Hallek, MD | Medizinische Universitaetsklinik I at the University of Cologne | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kreiskrankenhaus | Bad Hersfeld | 36251 | Germany | |||
| DIAKO Ev. Diakonie Krankenhaus gGmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25196783 | Result | 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. |
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| Bremen |
| 28239 |
| Germany |
| Medizinische Universitaetsklinik I at the University of Cologne | Cologne | D-50924 | Germany |
| Universitaetsklinikum Essen | Essen | D-45122 | Germany |
| Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie | Giessen | 35392 | Germany |
| St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH | Hagen | 58095 | Germany |
| Allgemeines Krankenhaus Hagen | Hagen | D-58095 | Germany |
| Praxis fur Innere Medizin - Hamburg | Hamburg | 22457 | Germany |
| Asklepios Klinik St. Georg | Hamburg | D-20099 | Germany |
| Marienhospital at Ruhr University Bochum | Herne | D-44625 | Germany |
| Clinic for Bone Marrow Transplantation and Hematology and Oncology | Idar-Oberstein | D-55743 | Germany |
| Internistische Gemeinschaftspraxis - Kassel | Kassel | 34117 | Germany |
| Internistische Onkologische Praxis - Kronach | Kronach | 96317 | Germany |
| Klinikum der Universitaet Muenchen - Grosshadern Campus | Munich | D-81377 | Germany |
| Klinikum Oldenburg | Oldenburg | D-26133 | Germany |
| Marienhospital Stuttgart | Stuttgart | 70199 | Germany |
| Haematologische Praxis | Weiden | D-92637 | Germany |
| Medizinische Poliklinik, Universitaet Wuerzburg | Würzburg | D-97070 | Germany |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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