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

Sponsor

German CLL Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00278213

Collaborator

(none)

Enrollment

Locations

Duration (Months)

0.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Prolymphocytic Leukemia	Biological: alemtuzumab Drug: cyclophosphamide Drug: fludarabine phosphate Drug: mitoxantrone hydrochloride	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

17 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2002

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Dec 1, 2009

Outcome Measures

Primary Outcome Measures

Adverse effects at 2 months after treatment []
Remission rate at 2 months after treatment []

Secondary Outcome Measures

Overall survival at 2 months after treatment []
Progression-free survival at 2 months after treatment []
Remission quality at 2 months after treatment []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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
5	Helios Klinikum Erfurt	Erfurt	Germany	D-99089
6	Universitaetsklinikum Essen	Essen	Germany	D-45147
7	Klinikum Garmisch - Partenkirchen GmbH	Garmisch-Partenkirchen	Germany	N 82467
8	Sana Klinikum Hof	Hof	Germany	95032
9	University Hospital Schleswig-Holstein - Kiel Campus	Kiel	Germany	D-24116
10	Internistische Praxis - Ludwigsburg	Ludwigsburg	Germany	71638
11	Sana Kliniken Luebeck	Luebeck	Germany	D-23560
12	Haematologische Praxis - Moenchengladbach	Moenchengladbach	Germany	41239
13	Gemeinschaftliche Schwerpunktpraxis - Osnabrueck	Osnabrueck	Germany	49074
14	Caritasklinik St. Theresia	Saarbrucken	Germany	D-66113
15	Schwerpunktpraxis fuer Haematologie und Onkologie	Saarbruecken	Germany	66113
16	Southwest German Cancer Center at Eberhard-Karls-University	Tuebingen	Germany	D-72076
17	Dr. Horst-Schmidt-Kliniken	Wiesbaden	Germany	D-65199
18	Hamatologisch - Onkologische Praxis Wurzburg	Wurzburg	Germany	97070
19	Klinikum des Landkreises Loebau-Zittau GmbH	Zittau	Germany	02763