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

NCT00278213 | Completed Phase 2

• 2 other identifiers: T-PLL1EU-20562
• Study Type: interventional
• Target: 17
• Locations: 2 countries
• Sites: 19

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.

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

Outcome Measures

Primary Outcomes (2)

• Adverse effects at 2 months after treatment

• Remission rate at 2 months after treatment

Secondary Outcomes (3)

• Overall survival at 2 months after treatment

• Progression-free survival at 2 months after treatment

• Remission quality at 2 months after treatment

Interventions

alemtuzumab BIOLOGICAL

cyclophosphamide DRUG

fludarabine phosphate DRUG

mitoxantrone hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• German CLL Study Group: lead

Study Sites (19)

Allgemeines Krankenhaus - Universitatskliniken

Vienna, A-1090, Austria

Location

Hanuschkrankenhaus

Vienna, A-1140, Austria

Location

Allgemeinen Krankenhaus Celle Kinderklinik

Celle, 29223, Germany

Location

St. Johannes Hospital - Medical Klinik II

Duisburg, D-47166, Germany

Location

Helios Klinikum Erfurt

Erfurt, D-99089, Germany

Location

Universitaetsklinikum Essen

Essen, D-45147, Germany

Location

Klinikum Garmisch - Partenkirchen GmbH

Garmisch-Partenkirchen, N 82467, Germany

Location

Sana Klinikum Hof

Hof, 95032, Germany

Location

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24116, Germany

Location

Internistische Praxis - Ludwigsburg

Ludwigsburg, 71638, Germany

Location

Sana Kliniken Luebeck

Lübeck, D-23560, Germany

Location

Haematologische Praxis - Moenchengladbach

Mönchengladbach, 41239, Germany

Location

Gemeinschaftliche Schwerpunktpraxis - Osnabrueck

Osnabrück, 49074, Germany

Location

Schwerpunktpraxis fuer Haematologie und Onkologie

Saarbrücken, 66113, Germany

Location

Caritasklinik St. Theresia

Saarbrücken, D-66113, Germany

Location

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, D-72076, Germany

Location

Dr. Horst-Schmidt-Kliniken

Wiesbaden, D-65199, Germany

Location

Hamatologisch - Onkologische Praxis Wurzburg

Würzburg, 97070, Germany

Location

Klinikum des Landkreises Loebau-Zittau GmbH

Zittau, 02763, Germany

Location

Related 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, 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.

  PMID: 23512246 RESULT

MeSH Terms

Conditions

Leukemia, Prolymphocytic; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Large Granular Lymphocytic

Interventions

Alemtuzumab; Cyclophosphamide; fludarabine phosphate; Mitoxantrone

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, T-Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Quinones; Polycyclic Compounds

Study Officials

• Georg Hopfinger

  Hanusch-Krankenhaus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 16, 2006
• First Posted: January 18, 2006
• Study Start: September 1, 2002
• Primary Completion: February 1, 2007
• Study Completion: December 1, 2009
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); DE (17)