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

NCT ID: NCT00278213

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2009-12-31

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.

Conditions

Prolymphocytic Leukemia

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

alemtuzumab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

fludarabine phosphate

Intervention Type: DRUG

mitoxantrone hydrochloride

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German CLL Study Group

OTHER

Sponsor Role: lead

Principal Investigators

Georg Hopfinger

Role: STUDY_CHAIR

Hanusch-Krankenhaus

Locations

Allgemeines Krankenhaus - Universitatskliniken

Vienna, , Austria

Hanuschkrankenhaus

Vienna, , Austria

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

Lübeck, , Germany

Haematologische Praxis - Moenchengladbach

Mönchengladbach, , Germany

Gemeinschaftliche Schwerpunktpraxis - Osnabrueck

Osnabrück, , Germany

Schwerpunktpraxis fuer Haematologie und Onkologie

Saarbrücken, , Germany

Caritasklinik St. Theresia

Saarbrücken, , Germany

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, , Germany

Dr. Horst-Schmidt-Kliniken

Wiesbaden, , Germany

Hamatologisch - Onkologische Praxis Wurzburg

Würzburg, , Germany

Klinikum des Landkreises Loebau-Zittau GmbH

Zittau, , Germany

Countries

Austria; Germany

References

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.

Reference Type: RESULT

PMID: 23512246 (View on PubMed)

Other Identifiers

EU-20562

Identifier Type: -

Identifier Source: secondary_id

T-PLL1

Identifier Type: -

Identifier Source: org_study_id