NCT00278213

Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia

Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: German CLL Study Group · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others can find cancer cells and help kill them or carry cancer-killing substances to them. Combination chemotherapy followed by alemtuzumab may be effective in treating chronic lymphocytic leukemia and prolymphocytic leukemia. PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by alemtuzumab works in treating patients with T-cell chronic lymphocytic leukemia or prolymphocytic leukemia.

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 with induction chemotherapy comprising fludarabine, cyclophosphamide, and mitoxantrone hydrochloride followed by consolidation therapy comprising alemtuzumab. * Determine the remission rate in patients treated with this regimen. Secondary * Determine the overall and progression-free survival of patients treated with this regimen. * Determine the quality of remission in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive induction chemotherapy comprising fludarabine IV and cyclophosphamide IV for 3 days and mitoxantrone hydrochloride IV on 1 day. Treatment repeats every 28 days for up to 4 courses. Patients then receive consolidation therapy comprising alemtuzumab IV 3 times in week 1 and then weekly for up to 11 weeks. PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.

Conditions

• Prolymphocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	alemtuzumab
DRUG	cyclophosphamide
DRUG	fludarabine phosphate
DRUG	mitoxantrone hydrochloride

Timeline

• Start date: 2002-09-01
• Primary completion: 2007-02-01
• Completion: 2009-12-01
• First posted: 2006-01-18
• Last updated: 2018-05-11

Locations

19 sites across 2 countries: Austria, Germany