We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02157181
First Posted: June 5, 2014
Last Update Posted: June 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jurgen Barth, University of Giessen
  Purpose

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


Condition Intervention Phase
Hairy Cell Leukemia (HCL) Drug: 2CdA +/- Rituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia

Resource links provided by NLM:


Further study details as provided by Jurgen Barth, University of Giessen:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Overall remission rate (ORR) [ Time Frame: 4 months after treatment ]
    The rate of CR + PR will be determined


Other Outcome Measures:
  • 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

  • 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


  • 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

  • Overall survival (OS) [ Time Frame: From achieving a remission until death ]
    Determination of the overall survival times of all patients


Enrollment: 89
Study Start Date: June 2004
Study Completion Date: January 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157181


Locations
Germany
Community based hemato-oncology medical office
Ansbach, Germany, 91522
Community based hemato-oncology medical office
Aschaffenburg, Germany, 63739
Community based hemato-oncology medical office
Celle, Germany, 29221
St.-Johannes-Hospital
Dortmund, Germany, 44137
Städtische Kliniken Esslingen
Esslingen, Germany, 73728
Universitätsklinik Frankfurt
Frankfurt am Main, Germany, 60596
Universitätsklinik Freiburg
Freiburg, Germany, 79106
Community based hemato-oncology medical office
Fürth, Germany, 90766
University Clinic | Med. Cinic IV Justus-Liebig-University
Gießen, Germany, 3592
Wilhelm-Anton-Hospital
Goch, Germany, 47574
Kath. Krankenhaus Hagen gem. GmbH
Hagen, Germany, 58095
Community based hemato-oncology medical office
Halle, Germany, 06108
Community based hemato-oncology medical office
Hamburg, Germany, 21073
Meditinische Hochschule (MHH)
Hannover, Germany, 30623
Community based hemato-oncology medical office
Heidelberg, Germany, 69115
Marienhospital Herne/ Klinikum der Ruhr-Universität Bochum
Herne, Germany, 44625
Community based hemato-oncology medical office
Hilden, Germany, 40721
Community based hemato-oncology medical office
Hildesheim, Germany, 31134
Klinikum Idar-Oberstein
Idar-Oberstein, Germany, 55743
Community based hemato-oncology medical office
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
Städtische Kliniken
Leverkusen, Germany, 51375
Community based hemato-oncology medical office
Magdeburg, Germany, 39104
Community based hemato-oncology medical office
Marburg, Germany, 35037
Klinik Schwäbisch Gmünd / Staufer Klinik
Mutlangen, Germany, 73557
Community based hemato-oncology medical office
München, Germany, 80335
Community based hemato-oncology medical office
München, Germany, 81241
Klinikum Großhadern
München, Germany, 81377
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
MVZ Klinikum Osnabrück
Osnabrück, Germany, 49076
Community based hemato-oncology medical office
Pforzheim, Germany, 75179
Klinikum Ernst von Bergmann gGmbH
Potsdam, Germany, 14467
St. Josefs-Krankenhaus
Potsdam, Germany, 14471
Community based hemato-oncology medical office
Schweinfurt, Germany, 97421
St. Marien-Krankenhaus
Siegen, Germany, 57072
Community based hemato-oncology medical office
Straubing, Germany, 94315
Diakonie-Klinikum Stuttgart
Stuttgart, Germany, 70176
Community based hemato-oncology medical office
Villingen, Germany, 78050
Community based hemato-oncology medical office
Wolfsburg, Germany, 38440
Sponsors and Collaborators
Jurgen Barth
Investigators
Principal Investigator: Mathias J Rummel, Prof. Dr. Justus-Liebig-University | University Hospital | Medicinal Clinic IV
  More Information

Additional Information:
Responsible Party: Jurgen Barth, Professor Dr. med Mathias Rummel, University of Giessen
ClinicalTrials.gov Identifier: NCT02157181     History of Changes
Other Study ID Numbers: NHL 4-2004
First Submitted: May 21, 2014
First Posted: June 5, 2014
Last Update Posted: June 5, 2014
Last Verified: June 2014

Keywords provided by Jurgen Barth, University of Giessen:
HCL variant
HCL relapse
Risk stratified

Additional relevant MeSH terms:
Cladribine
Leukemia
Leukemia, Hairy Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
2-chloro-3'-deoxyadenosine
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action