Not Signed In -
Fludarabine Phosphate |
Fludara |
Clinical Trial: Phase II Study to Evaluate the Combination of Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients with B-CLL
This study is currently recruiting patients.
Verified by University of Cologne September 2005
|
Purpose
This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia
| Condition | Intervention | Phase |
|---|---|---|
| B-cell Chronic Lymphocytic Leukemia | Drug: Fludarabine Drug: Cyclophosphamide Drug: Alemtuzumab | Phase II |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Multicenter Phase II Trial of Fludarabine and Cyclophosphamide in Combination with Alemtuzumab (FC-Cam) for Patients with Relapsed Chronic Lymphocytic Leukemia - CLL-2L Protocol of the German CLL-Study Group (GCLLSG)
Further Study Details:
Primary Outcomes: Overall response rate (complete and partial response rate)
Secondary Outcomes: Toxicity; MRD response rate; Response rate in biological defined risk groups; Duration of response; Treatment administration (dose intensity); Overall survival
Expected Total Enrollment: 100
Secondary Outcomes: Toxicity; MRD response rate; Response rate in biological defined risk groups; Duration of response; Treatment administration (dose intensity); Overall survival
Expected Total Enrollment: 100
Study start: January 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- B-CLL in need of treatment
- One or two prior prior therapies
- WHO performance status 0-2
Exclusion Criteria:
- Serum creatinine > 1.5 ULN
- Major organ dysfunctions
- Pregnant or nursing
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00147901
Sandra Stein +49/221/478 Ext. 3988 cllstudie@uk-koeln.de
Germany, NRW
University of Cologne, Cologne, NRW, 50924, Germany; Recruiting
Sven Trelle +49/221/478 Ext. 6128 sven.trelle@uk-koeln.de
Study chairs or principal investigators
Andreas Engert, Principal Investigator, University of Cologne
More Information
Study ID Numbers: CLL-2L
Last Updated: September 6, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00147901
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 6, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00147901
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
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