Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab

June 3, 2014 updated by: Jurgen Barth

Study on the Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia

The study will test the effectiveness (rate of complete remissions, total remission rate and duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous cladribine (LITAK®) plus anti-CD20* antibody rituximab in patients requiring treatment for relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous therapy.

CD20* = cluster of differentiation antigen 20

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The trial is a prospective, multi-centre, open Phase II study on patients with hairy cell leukaemia variant or with relapsed hairy cell leukaemia.

Study Type

Interventional

Enrollment (Actual)

89

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

  • Germany
      • Ansbach, Germany, 91522
        • Community based hemato-oncology medical office
      • Aschaffenburg, Germany, 63739
        • Community based hemato-oncology medical office
      • Celle, Germany, 29221
        • Community based hemato-oncology medical office
      • Dortmund, Germany, 44137
        • St.-Johannes-Hospital
      • Esslingen, Germany, 73728
        • Städtische Kliniken Esslingen
      • Frankfurt am Main, Germany, 60596
        • Universitätsklinik Frankfurt
      • Freiburg, Germany, 79106
        • Universitätsklinik Freiburg
      • Fürth, Germany, 90766
        • Community based hemato-oncology medical office
      • Gießen, Germany, 3592
        • University Clinic | Med. Cinic IV Justus-Liebig-University
      • Goch, Germany, 47574
        • Wilhelm-Anton-Hospital
      • Hagen, Germany, 58095
        • Kath. Krankenhaus Hagen gem. GmbH
      • Halle, Germany, 06108
        • Community based hemato-oncology medical office
      • Hamburg, Germany, 21073
        • Community based hemato-oncology medical office
      • Hannover, Germany, 30623
        • Meditinische Hochschule (MHH)
      • Heidelberg, Germany, 69115
        • Community based hemato-oncology medical office
      • Herne, Germany, 44625
        • Marienhospital Herne/ Klinikum der Ruhr-Universität Bochum
      • Hilden, Germany, 40721
        • Community based hemato-oncology medical office
      • Hildesheim, Germany, 31134
        • Community based hemato-oncology medical office
      • Idar-Oberstein, Germany, 55743
        • Klinikum Idar-Oberstein
      • Jena, Germany, 07743
        • Community based hemato-oncology medical office
      • Kassel, Germany, 34125
        • Community based hemato-oncology medical office
      • Kiel, Germany, 24105
        • Community based hemato-oncology medical office
      • Koblenz, Germany, 56068
        • Community based hemato-oncology medical office
      • Kronach, Germany, 96317
        • Community based hemato-oncology medical office
      • Leer, Germany, 26789
        • Community based hemato-oncology medical office
      • Leipzig, Germany, 04103
        • Community based hemato-oncology medical office
      • Leverkusen, Germany, 51375
        • Städtische Kliniken
      • Magdeburg, Germany, 39104
        • Community based hemato-oncology medical office
      • Marburg, Germany, 35037
        • Community based hemato-oncology medical office
      • Mutlangen, Germany, 73557
        • Klinik Schwäbisch Gmünd / Staufer Klinik
      • München, Germany, 81377
        • Klinikum Großhadern
      • München, Germany, 80335
        • Community based hemato-oncology medical office
      • München, Germany, 81241
        • Community based hemato-oncology medical office
      • Neunkirchen, Germany, 66538
        • Community based hemato-oncology medical office
      • Neuwied, Germany, 56564
        • Community based hemato-oncology medical office
      • Niddatal, Germany, 61194
        • Community based hemato-oncology medical office
      • Nürnberg, Germany, 90449
        • Community based hemato-oncology medical office
      • Osnabrück, Germany, 49076
        • MVZ Klinikum Osnabrück
      • Pforzheim, Germany, 75179
        • Community based hemato-oncology medical office
      • Potsdam, Germany, 14467
        • Klinikum Ernst von Bergmann gGmbH
      • Potsdam, Germany, 14471
        • St. Josefs-Krankenhaus
      • Schweinfurt, Germany, 97421
        • Community based hemato-oncology medical office
      • Siegen, Germany, 57072
        • St. Marien-Krankenhaus
      • Straubing, Germany, 94315
        • Community based hemato-oncology medical office
      • Stuttgart, Germany, 70176
        • Diakonie-Klinikum Stuttgart
      • Villingen, Germany, 78050
        • Community based hemato-oncology medical office
      • Wolfsburg, Germany, 38440
        • Community based hemato-oncology medical office

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
  • Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
  • Need for treatment is indicated (see 4.3 below)
  • Age at least 18 years
  • General state of health according to WHO 0-2
  • Written declaration of consent by the patient
  • Current histology, which should not be older than 6 months, is necessary

Exclusion Criteria:

  • Patients, who do not fulfil the above-mentioned inclusion criteria.
  • Patients with severe functional limitations of the heart according to New York Heart Association III / IV, of the lung according to WHO degree III / IV, the liver (bilirubin > 2mg/dl, alkaline phosphatase, raised GOT and GPT (glutamate- pyruvate transaminase) values more than twice normal), diseases of the central nervous system, including psychoses. Creatinine > 2 mg/dl, or creatinine clearance < 50 mg/min
  • Patients with proven HIV infections
  • Patients with active hepatitis
  • Patients with other florid infections
  • Patients with anamnesis / diagnosis of another malignant disease (other than nonmelanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
  • Pregnant or lactating women

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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCL, 2CdA +/- Rituximab

Risk stratification

  1. HCL variant will be treated with cladribine plus rituximab, independent of previous therapy
  2. Relapses of HCL will be treated with cladribine plus rituximab, duration of remission of the previous therapy is < 3 years.

  3. All repeated relapses (> 1st relapse) after previous therapies with purine analogues and/or interferon will be treated with cladribine plus rituximab.

    Cladribine (LITAK®) 0.14 mg/kg daily Days 8-12 subcutaneous bolus injection Rituximab (Mabthera®) 375 mg/m2 daily Days 1, 8, 15, 22 infusion

  4. Relapses of HCL will be treated with cladribine monotherapy, if the duration of remission of the previous therapy is > 3 years.

Cladribine (LITAK®) 0.14 mg/kg daily Days 1-5 subcutaneous bolus injection
Drug: 2CdA +/- Rituximab
Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion
Other Names:
  • Cladribine, Syn 2CdA, (LITAK®) 0.14 mg/kg
  • Rituximab (Mabthera®; Rituxan®) 375 mg/m²

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complete remissions (CR)
Time Frame: 4 months after treatment

Determination of the rate of complete remission and duration of remission after one cycle of subcutaneous cladribine (LITAK®) plus four administrations of rituximab

  • in patients with hairy cell leukaemia variant
  • in patients with relapsed hairy cell leukaemia
4 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall remission rate (ORR)
Time Frame: 4 months after treatment
The rate of CR + PR will be determined
4 months after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute and late toxicity
Time Frame: From day 1 of treatment period up to 120 months
All kind of adverse events, laboratory abnormalities, infections, unplanned hospitalisations will be measured
From day 1 of treatment period up to 120 months
Degree of induced immunodeficiency
Time Frame: From day 1 of treatment period up to 120 months

Degree of immunosupression with CD4/CD8 quotient as indicating biomarker will be measured.

Duration of immunosupression as well as infectious and other complications which result from therapy will be reported
From day 1 of treatment period up to 120 months
Frequency of secondary neoplasia during the life-long follow-up period
Time Frame: From day 1 of treatment period up to 120 months
Rate of secondary neoplasia as safety issue will be determined
From day 1 of treatment period up to 120 months
Overall survival (OS)
Time Frame: From achieving a remission until death
Determination of the overall survival times of all patients
From achieving a remission until death

Collaborators and Investigators

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

Sponsor

Jurgen Barth

Investigators

  • Principal Investigator: Mathias J Rummel, Prof. Dr., Justus-Liebig-University | University Hospital | Medicinal Clinic IV

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.

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

June 1, 2004

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHL 4-2004

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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