Overview

This trial is active, not recruiting.

Condition leukemia
Treatments alemtuzumab, cyclophosphamide, fludarabine phosphate, mitoxantrone hydrochloride
Phase phase 2
Target CD52
Sponsor German CLL Study Group
Start date September 2002
Trial size 17 participants
Trial identifier NCT00278213, CDR0000454588, EU-20562, GCLLSG-T-PLL1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Adverse effects at 2 months after treatment
time frame:
Remission rate at 2 months after treatment
time frame:

Secondary Outcomes

Measure
Overall survival at 2 months after treatment
time frame:
Progression-free survival at 2 months after treatment
time frame:
Remission quality at 2 months after treatment
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).