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

May 9, 2018 updated by: German CLL Study Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Allgemeines Krankenhaus - Universitatskliniken
      • Vienna, Austria, A-1140
        • Hanuschkrankenhaus
  • Germany
      • Celle, Germany, 29223
        • Allgemeinen Krankenhaus Celle Kinderklinik
      • Duisburg, Germany, D-47166
        • St. Johannes Hospital - Medical Klinik II
      • Erfurt, Germany, D-99089
        • Helios Klinikum Erfurt
      • Essen, Germany, D-45147
        • Universitaetsklinikum Essen
      • Garmisch-Partenkirchen, Germany, N 82467
        • Klinikum Garmisch - Partenkirchen GmbH
      • Hof, Germany, 95032
        • Sana Klinikum Hof
      • Kiel, Germany, D-24116
        • University Hospital Schleswig-Holstein - Kiel Campus
      • Ludwigsburg, Germany, 71638
        • Internistische Praxis - Ludwigsburg
      • Luebeck, Germany, D-23560
        • Sana Kliniken Luebeck
      • Moenchengladbach, Germany, 41239
        • Haematologische Praxis - Moenchengladbach
      • Osnabrueck, Germany, 49074
        • Gemeinschaftliche Schwerpunktpraxis - Osnabrueck
      • Saarbrucken, Germany, D-66113
        • Caritasklinik St. Theresia
      • Saarbruecken, Germany, 66113
        • Schwerpunktpraxis fuer Haematologie und Onkologie
      • Tuebingen, Germany, D-72076
        • Southwest German Cancer Center at Eberhard-Karls-University
      • Wiesbaden, Germany, D-65199
        • Dr. Horst-Schmidt-Kliniken
      • Wurzburg, Germany, 97070
        • Hamatologisch - Onkologische Praxis Wurzburg
      • Zittau, Germany, 02763
        • Klinikum des Landkreises Loebau-Zittau GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse effects at 2 months after treatment
Remission rate at 2 months after treatment

Secondary Outcome Measures

Outcome Measure
Overall survival at 2 months after treatment
Progression-free survival at 2 months after treatment
Remission quality at 2 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German CLL Study Group

Investigators

  • Study Chair: Georg Hopfinger, Hanusch-Krankenhaus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 16, 2006

First Submitted That Met QC Criteria

January 16, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-PLL1
  • EU-20562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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