Consolidation With Campath-1H After FMC Induction in Patients With T-Cell Chronic Lymphocytic Leukemia
18 Years
65 Years
Both
Leukemia
Trial Information
Consolidation With Campath-1H After FMC Induction in Patients With T-Cell Chronic Lymphocytic Leukemia
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Adverse effects at 2 months after treatment
Safety Issue:
Yes
Principal Investigator
Georg Hopfinger
Investigator Role:
Study Chair
Investigator Affiliation:
Hanusch-Krankenhaus
Authority:
United States: Federal Government
Study ID:
CDR0000454588
NCT ID:
NCT00278213
Start Date:
September 2002
Completion Date:
Related Keywords:
- Leukemia
- prolymphocytic leukemia
- refractory chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- T-cell large granular lymphocyte leukemia
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Leukemia, Prolymphocytic
- Leukemia, Prolymphocytic, T-Cell
Name | Location |
|---|
