Clinical trial NCT00278213: Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
Official title: Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prolymphocytic Leukemia
Keywords: 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
Lead sponsor: German CLL Study Group
Sponsor class: OTHER
First posted: 2006-01-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Adverse effects at 2 months after treatment
measure: Remission rate at 2 months after treatment
Secondary outcomes:
measure: Overall survival at 2 months after treatment
measure: Progression-free survival at 2 months after treatment
measure: Remission quality at 2 months after treatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus - Universitatskliniken
city: Vienna
country: Austria
facility: Hanuschkrankenhaus
city: Celle
country: Germany
facility: Allgemeinen Krankenhaus Celle Kinderklinik
city: Duisburg
country: Germany
facility: St. Johannes Hospital - Medical Klinik II
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Garmisch-Partenkirchen
country: Germany
facility: Klinikum Garmisch - Partenkirchen GmbH
city: Hof
country: Germany
facility: Sana Klinikum Hof
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein - Kiel Campus
city: Ludwigsburg
country: Germany
facility: Internistische Praxis - Ludwigsburg
city: Luebeck
country: Germany
facility: Sana Kliniken Luebeck
city: Moenchengladbach
country: Germany
facility: Haematologische Praxis - Moenchengladbach
city: Osnabrueck
country: Germany
facility: Gemeinschaftliche Schwerpunktpraxis - Osnabrueck
city: Saarbrucken
country: Germany
facility: Caritasklinik St. Theresia
city: Saarbruecken
country: Germany
facility: Schwerpunktpraxis fuer Haematologie und Onkologie
city: Tuebingen
country: Germany
facility: Southwest German Cancer Center at Eberhard-Karls-University
city: Wiesbaden
country: Germany
facility: Dr. Horst-Schmidt-Kliniken
city: Wurzburg
country: Germany
facility: Hamatologisch - Onkologische Praxis Wurzburg
city: Zittau
country: Germany
facility: Klinikum des Landkreises Loebau-Zittau GmbH
Study officials:
affiliation: Hanusch-Krankenhaus
name: Georg Hopfinger
role: STUDY_CHAIR
References:
citation: Hopfinger G, Busch R, Pflug N, Weit N, Westermann A, Fink AM, Cramer P, Reinart N, Winkler D, Fingerle-Rowson G, Stilgenbauer S, Dohner H, Kandler G, Eichhorst B, Hallek M, Herling M. Sequential chemoimmunotherapy of fludarabine, mitoxantrone, and cyclophosphamide induction followed by alemtuzumab consolidation is effective in T-cell prolymphocytic leukemia. Cancer. 2013 Jun 15;119(12):2258-67. doi: 10.1002/cncr.27972. Epub 2013 Mar 19.