Clincosm LogoSign in Get a demo

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Sponsor
University of Giessen (Other)
Overall Status
Recruiting
CT.gov ID
NCT02131753
Collaborator
(none)
210
Enrollment
76
Locations
1
Arm
283
Duration (Months)
2.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle of cladribine in patients with hairy cell leukemia requiring treatment.

They have to be untreated so far or may be pretreated with alpha-interferon.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cladribine s.c. injection, HCL treatment
 Phase 2/Phase 3

Detailed Description

Evaluation of remission status will take place 4 months after treatment. In addition, it will be tested whether patients with non-optimal response will have a benefit from a second cycle of cladribine.

Non-optimal response is: patients with detectable residual disease; achievement of partial remission or detectable residual infiltration in the bone marrow.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Therapy Optimisation for the Treatment of Hairy Cell Leukemia
Study Start Date :
May 1, 2004
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Other: Cladribine s.c. injection, HCL treatment

Cladribine 0.14 mg/kg body weight for 5 consecutive days (d 1 - 5) as subcutaneous bolus injection for patients with hairy cell leukemia needing treatment

Drug: Cladribine s.c. injection, HCL treatment
Patients with hairy cell leukemia and the need for treatment are given cladribine 0.14 mg/kg for 5 consecutive days as a s. c bolus injection
Other Names:
  • Litak(R)
  • 2-CdA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Determination of the rate of complete remissions after one cycle with subcutaneous cladribine [4 months after treatment]

    Secondary Outcome Measures

    1. Rate of complete remissions in patient who still have detectable residual disease [4 months after treatment]

      A second cycle of cladribine after an interval of 4 months following the first cycle.

    Other Outcome Measures

    1. Overall effectiveness [20 years]

      Determination of: overall remission rate duration of remission immunodeficiency induced by treatment, its duration, infectious and other complications resulting from that frequency of secondary neoplasia during life long follow up overall survival

    2. Improvement of remission deepness [Date of staging after first cycle + 4 months]

      Can a complete remission be achieved with a second cycle in patients who have achieved only a partial remission after one cycle?

    3. Improvement of remission quality [Date of staging after first cycle + 4 months]

      Can the quality of remission achieved with the first cycle be improved with a second cycle?

    4. Lowering risk of relapse [Date of proven remission until the date of firdt documented progression or date of death from any cause, whichever came first, assessed up to 20 years]

      Can the expected risk of relapse be lowered and the duration of remission be prolonged?

    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 leukemia

    • Presence of hairy cells in the bone marrow and peripheral blood detected by positive TRAP staining and / or co expression if cell surface antigens cluster of differentiation (CD) 19/CD25 or CD19/CD103 (b-ly7)

    • No previous cytostatic treatment (splenectomy or interferon treatment are allowed)

    • Need for treatment

    • Age at least 18 years old

    • General state of health according to WHO 0-2

    • Current histology, not older than 6 months

    • Written consent by patient

    Exclusion Criteria:

    • Patients not fulfilling inclusion criteria above

    • Hairy cell leukemia variants (HCL-V): presence of lymphoid cells in bone marrow and / or peripheral blood, which have an intermediate morphology between hairy cells and prolymphocytes (negative TRAP staining and co- expression of CD19/CD103 without CD25

    • Pretreatment with purine analogues or other chemotherapeutics

    • Concomitant corticosteroid therapy

    • Severe dysfunction of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver, except due to lymphoma (bilirubin > 2 mg/dl, alkaline phosphatase, glutamate-oxalacetate transaminase and glutamate-pyruvate transaminase > 2 x upper limit of normal), the kidneys (creatinin > 2 mg/dl or creatinine clearance < 50 ml/min), central nervous system diseases including psychoses.

    • Proven HIV infection

    • Active Hepatitis

    • Other florid infections

    • Anamnesis / diagnosis of other malignant disease (other than non-melanoma 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 Rhön-Saale-Klinik gGmbH Bad Neustadt An Der Saale Germany 97616
    4 Community based hemato-oncology medical office Berlin Germany 10407
    5 Charité - Universitätsmedizin Berlin Berlin Germany 12203
    6 Community based hemato-oncology medical office Bremen Germany 28209
    7 Community based hemato-oncology medical office Celle Germany 29221
    8 Community based hemato-oncology medical office Cottbus Germany 03046
    9 Community based hemato-oncology medical office Darmstadt Germany 64295
    10 Community based hemato-oncology medical office Dresden Germany 01127
    11 Community based hemato-oncology medical office Duisburg Germany 47166
    12 Klinik Duisburg-West Duisburg Germany 47228
    13 Universitätsklinik Düsseldorf Düsseldorf Germany 40255
    14 Community based hemato-oncology medical office Ehingen Germany 89584
    15 Community based hemato-oncology medical office Erlangen Germany 91052
    16 Community based hemato-oncology medical office Frankfurt Germany 60389
    17 Krankenhaus Nordwest Frankfurt Germany 60488
    18 Community based hemato-oncology medical office Freiburg Germany 79106
    19 Community based hemato-oncology medical office Friedrichshafen Germany 88045
    20 Community based hemato-oncology medical office Fürth Germany 90766
    21 Community based hemato-oncology medical office Germering Germany 82110
    22 Community based hemato-oncology medical office Gießen Germany 35392
    23 University Clinic | Medicinal Clinic IV Gießen Germany 35592
    24 St.-Marien-Hospital Hagen Germany 58095
    25 Community based hemato-oncology medical office Halle Germany 06110
    26 Evangelisches Krankenhaus Hamm Germany 59063
    27 Community based hemato-oncology medical office Hanau Germany 63450
    28 Community based hemato-oncology medical office Heidelberg Germany 69115
    29 Community based hemato-oncology medical office Herne Germany 44623
    30 Marienkrankenhaus Herne Germany 44625
    31 Community based hemato-oncology medical office Homberg Germany 34576
    32 Community based hemato-oncology medical office Kaiserslautern Germany 67655
    33 Städtisches Klinikum Karlsruhe Germany 76137
    34 Community based hemato-oncology medical office Kassel Germany 34117
    35 Klinikum Kempten-Oberallgäu Kempten Germany 87439
    36 Community based hemato-oncology medical office Koblenz Germany 56068
    37 Community based hemato-oncology medical office Krefeld Germany 47798
    38 Community based hemato-oncology medical office Kronach Germany 96317
    39 Community based hemato-oncology medical office Landau Germany 76829
    40 Community based hemato-oncology medical office Landshut Germany 84028
    41 Community based hemato-oncology medical office Landshut Germany 84034
    42 Klinikum Leverkusen GmbH Leverkusen Germany 51375
    43 St. Marienkrankenhaus Ludwigshafen Germany 67067
    44 Community based hemato-oncology medical office Lüdenscheid Germany 58507
    45 Universitätsklinik Mainz Mainz Germany 55131
    46 Community based hemato-oncology medical office Marburg Germany 35037
    47 Community based hemato-oncology medical office Mönchengladbach Germany 41239
    48 Community based hemato-oncology medical office München Germany 80335
    49 University Clinic Großhadern München Germany 81377
    50 Community based hemato-oncology medical office Neumarkt Germany 92318
    51 Community based hemato-oncology medical office Nürnberg Germany 90403
    52 Community based hemato-oncology medical office Nürnberg Germany 90449
    53 St. Clemens Hospital Oberhausen Germany 46145
    54 St. Martinus-Hospital Olpe Germany 57462
    55 Community based hemato-oncology medical office Osnabrück Germany 49074
    56 St. Josefs-Krankenhaus Potsdam Germany 14471
    57 Community based hemato-oncology medical office Rehling Germany 86508
    58 Community based hemato-oncology medical office Rüsselsheim Germany 65428
    59 Caritas Klinik St. Theresia Saarbrücken Germany 66113
    60 Community based hemato-oncology medical office Schkeuditz Germany 04435
    61 Kreiskrankenhaus Schotten Schotten Germany 63679
    62 Community based hemato-oncology medical office Schweinfurt Germany 97421
    63 Community based hemato-oncology medical office Siegen Germany 57072
    64 St.-Marien-Krankenhaus Siegen Germany 57072
    65 Diakonie - Klinikum Stuttgart Stuttgart Germany 70176
    66 Community based hemato-oncology medical office Trier Germany 54290
    67 Community based hemato-oncology medical office Tübingen Germany 72072
    68 University Clinic Ulm Ulm Germany 89081
    69 Städtisches Krankenhaus Villingen Villingen-Schwenningen Germany 78050
    70 Community based hemato-oncology medical office Weilheim Germany 82362
    71 Sophien- und Hufeland Klinikum Weimar Germany 99425
    72 Asklepios Nordseeklinik Westerland Germany 25980
    73 Community based hemato-oncology medical office Wiesbaden Germany 65191
    74 Dr. Horst-Schmidt-Kliniken Wiesbaden Germany 65199
    75 Community based hemato-oncology medical office Wilhelmshaven Germany 26389
    76 Community based hemato-oncology medical office Wolfsburg Germany 38440

    Sponsors and Collaborators

    • University of Giessen

    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, Head of StiL Coordinating Center, University of Giessen
    ClinicalTrials.gov Identifier:
    NCT02131753
    Other Study ID Numbers:
    • NHL 3-2004
    First Posted:
    May 6, 2014
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Jurgen Barth, Head of StiL Coordinating Center, University of Giessen
    hairy cell leukemia
    untreated
    cladribine subcutaneous
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Hairy Cell
    Cladribine

    Study Results

    No Results Posted as of May 18, 2022