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

Prolymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00278213
• Other study ID #: T-PLL1
• Secondary ID: EU-20562
• Status: Completed
• Phase: Phase 2
• Start date: September 2002
• Est. completion date: December 2009

Study information

• Verified date: May 2018
• Source: German CLL Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2009
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Prolymphocytic
• Prolymphocytic Leukemia

Intervention

Biological:
• alemtuzumab

Drug:
• cyclophosphamide

• fludarabine phosphate

• mitoxantrone hydrochloride

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus - Universitatskliniken	Vienna
Austria	Hanuschkrankenhaus	Vienna
Germany	Allgemeinen Krankenhaus Celle Kinderklinik	Celle
Germany	St. Johannes Hospital - Medical Klinik II	Duisburg
Germany	Helios Klinikum Erfurt	Erfurt
Germany	Universitaetsklinikum Essen	Essen
Germany	Klinikum Garmisch - Partenkirchen GmbH	Garmisch-Partenkirchen
Germany	Sana Klinikum Hof	Hof
Germany	University Hospital Schleswig-Holstein - Kiel Campus	Kiel
Germany	Internistische Praxis - Ludwigsburg	Ludwigsburg
Germany	Sana Kliniken Luebeck	Luebeck
Germany	Haematologische Praxis - Moenchengladbach	Moenchengladbach
Germany	Gemeinschaftliche Schwerpunktpraxis - Osnabrueck	Osnabrueck
Germany	Caritasklinik St. Theresia	Saarbrucken
Germany	Schwerpunktpraxis fuer Haematologie und Onkologie	Saarbruecken
Germany	Southwest German Cancer Center at Eberhard-Karls-University	Tuebingen
Germany	Dr. Horst-Schmidt-Kliniken	Wiesbaden
Germany	Hamatologisch - Onkologische Praxis Wurzburg	Wurzburg
Germany	Klinikum des Landkreises Loebau-Zittau GmbH	Zittau

Sponsors (1)

Lead Sponsor	Collaborator
German CLL Study Group

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (1)

Hopfinger G, Busch R, Pflug N, Weit N, Westermann A, Fink AM, Cramer P, Reinart N, Winkler D, Fingerle-Rowson G, Stilgenbauer S, Döhner H, Kandler G, Eichhorst B, Hallek M, Herling M. Sequential chemoimmunotherapy of fludarabine, mitoxantrone, and cycloph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse effects at 2 months after treatment
Primary	Remission rate at 2 months after treatment
Secondary	Overall survival at 2 months after treatment
Secondary	Progression-free survival at 2 months after treatment
Secondary	Remission quality at 2 months after treatment

External Links

•   Click here for more information about this study: T-PLL1 (German CLL Study Group)