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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 October 2016 |
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Main ID: |
NCT00309881 |
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Date of registration:
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29/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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)
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Scientific title:
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CHOP Plus Rituximab (CHOP-R) in Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL) or CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT) |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00309881 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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Contacts
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Name:
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Michael Hallek, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medizinische Universitaetsklinik I at the University of Cologne |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Lymphocytic Leukemia
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Intervention(s)
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Drug: cyclophosphamide
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Biological: rituximab
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Drug: prednisone
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Drug: doxorubicin hydrochloride
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Drug: vincristine sulfate
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Primary Outcome(s)
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Quality of remission
[Time Frame: No]
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Rate of remission
[Time Frame: No]
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Secondary Outcome(s)
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Overall survival
[Time Frame: No]
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Progression-free survival
[Time Frame: No]
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Toxicity
[Time Frame: Yes]
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Secondary ID(s)
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CLL2G
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EU-20549
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MEDAC-GCLLSG-CLL2G
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GCLLSG-423
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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