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

Sponsor
Jurgen Barth (Other)
Overall Status
Completed
CT.gov ID
NCT02157181
Collaborator
(none)
89
Enrollment
47
Locations
1
Arm
103
Duration (Months)
1.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: 2CdA +/- Rituximab
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
N/A
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
Study Start Date :
Jun 1, 2004
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of complete remissions (CR) [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

    1. Overall remission rate (ORR) [4 months after treatment]

      The rate of CR + PR will be determined

    Other Outcome Measures

    1. Acute and late toxicity [From day 1 of treatment period up to 120 months]

      All kind of adverse events, laboratory abnormalities, infections, unplanned hospitalisations will be measured

    2. Degree of induced immunodeficiency [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

    3. Frequency of secondary neoplasia during the life-long follow-up period [From day 1 of treatment period up to 120 months]

      Rate of secondary neoplasia as safety issue will be determined

    4. Overall survival (OS) [From achieving a remission until death]

      Determination of the overall survival times of all patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Community based hemato-oncology medical office Ansbach Germany 91522
    2 Community based hemato-oncology medical office Aschaffenburg Germany 63739
    3 Community based hemato-oncology medical office Celle Germany 29221
    4 St.-Johannes-Hospital Dortmund Germany 44137
    5 Städtische Kliniken Esslingen Esslingen Germany 73728
    6 Universitätsklinik Frankfurt Frankfurt am Main Germany 60596
    7 Universitätsklinik Freiburg Freiburg Germany 79106
    8 Community based hemato-oncology medical office Fürth Germany 90766
    9 University Clinic | Med. Cinic IV Justus-Liebig-University Gießen Germany 3592
    10 Wilhelm-Anton-Hospital Goch Germany 47574
    11 Kath. Krankenhaus Hagen gem. GmbH Hagen Germany 58095
    12 Community based hemato-oncology medical office Halle Germany 06108
    13 Community based hemato-oncology medical office Hamburg Germany 21073
    14 Meditinische Hochschule (MHH) Hannover Germany 30623
    15 Community based hemato-oncology medical office Heidelberg Germany 69115
    16 Marienhospital Herne/ Klinikum der Ruhr-Universität Bochum Herne Germany 44625
    17 Community based hemato-oncology medical office Hilden Germany 40721
    18 Community based hemato-oncology medical office Hildesheim Germany 31134
    19 Klinikum Idar-Oberstein Idar-Oberstein Germany 55743
    20 Community based hemato-oncology medical office Jena Germany 07743
    21 Community based hemato-oncology medical office Kassel Germany 34125
    22 Community based hemato-oncology medical office Kiel Germany 24105
    23 Community based hemato-oncology medical office Koblenz Germany 56068
    24 Community based hemato-oncology medical office Kronach Germany 96317
    25 Community based hemato-oncology medical office Leer Germany 26789
    26 Community based hemato-oncology medical office Leipzig Germany 04103
    27 Städtische Kliniken Leverkusen Germany 51375
    28 Community based hemato-oncology medical office Magdeburg Germany 39104
    29 Community based hemato-oncology medical office Marburg Germany 35037
    30 Klinik Schwäbisch Gmünd / Staufer Klinik Mutlangen Germany 73557
    31 Community based hemato-oncology medical office München Germany 80335
    32 Community based hemato-oncology medical office München Germany 81241
    33 Klinikum Großhadern München Germany 81377
    34 Community based hemato-oncology medical office Neunkirchen Germany 66538
    35 Community based hemato-oncology medical office Neuwied Germany 56564
    36 Community based hemato-oncology medical office Niddatal Germany 61194
    37 Community based hemato-oncology medical office Nürnberg Germany 90449
    38 MVZ Klinikum Osnabrück Osnabrück Germany 49076
    39 Community based hemato-oncology medical office Pforzheim Germany 75179
    40 Klinikum Ernst von Bergmann gGmbH Potsdam Germany 14467
    41 St. Josefs-Krankenhaus Potsdam Germany 14471
    42 Community based hemato-oncology medical office Schweinfurt Germany 97421
    43 St. Marien-Krankenhaus Siegen Germany 57072
    44 Community based hemato-oncology medical office Straubing Germany 94315
    45 Diakonie-Klinikum Stuttgart Stuttgart Germany 70176
    46 Community based hemato-oncology medical office Villingen Germany 78050
    47 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Jurgen Barth, Professor Dr. med Mathias Rummel, University of Giessen
    ClinicalTrials.gov Identifier:
    NCT02157181
    Other Study ID Numbers:
    • NHL 4-2004
    First Posted:
    Jun 5, 2014
    Last Update Posted:
    Jun 5, 2014
    Last Verified:
    Jun 1, 2014
    Keywords provided by Jurgen Barth, Professor Dr. med Mathias Rummel, University of Giessen
    HCL variant
    HCL relapse
    Risk stratified
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Hairy Cell
    Rituximab
    Cladribine

    Study Results

    No Results Posted as of Jun 5, 2014