Status:
COMPLETED
Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
Lead Sponsor:
German CLL Study Group
Conditions:
Prolymphocytic Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping th...
Detailed Description
OBJECTIVES: Primary * Determine the number of severe adverse events and life-threatening infections in patients with T-cell chronic lymphocytic leukemia or T-cell prolymphocytic leukemia treated wit...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of T-cell chronic lymphocytic leukemia (T-CLL) or T-cell prolymphocytic leukemia (T-PLL)
- Previously untreated disease OR patient may have received up to 2 therapies
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 6 months
- No severe organ dysfunction
- No other concurrent or previous neoplasm
- No autoimmune hemolytic anemia or thrombocytopenia
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior fludarabine, mitoxantrone hydrochloride, cyclophosphamide, or alemtuzumab
Exclusion
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00278213
Start Date
September 1 2002
End Date
December 1 2009
Last Update
May 11 2018
Active Locations (19)
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1
Allgemeines Krankenhaus - Universitatskliniken
Vienna, Austria, A-1090
2
Hanuschkrankenhaus
Vienna, Austria, A-1140
3
Allgemeinen Krankenhaus Celle Kinderklinik
Celle, Germany, 29223
4
St. Johannes Hospital - Medical Klinik II
Duisburg, Germany, D-47166