Clinical trial NCT02131753: Therapy Optimisation for the Treatment of Hairy Cell Leukemia
Official title: Therapy Optimisation for the Treatment of Hairy Cell Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Hairy Cell Leukemia
Keywords: hairy cell leukemia
untreated
cladribine subcutaneous
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determination of the rate of complete remissions after one cycle with subcutaneous cladribine
timeFrame: 4 months after treatment
Secondary outcomes:
measure: Rate of complete remissions in patient who still have detectable residual disease
timeFrame: 4 months after treatment
Other outcomes:
measure: Overall effectiveness
timeFrame: 20 years
measure: Improvement of remission deepness
timeFrame: Date of staging after first cycle + 4 months
measure: Improvement of remission quality
timeFrame: Date of staging after first cycle + 4 months
measure: Lowering risk of relapse
timeFrame: 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
Locations:
city: Ansbach
country: Germany
facility: Community based hemato-oncology medical office
city: Aschaffenburg
country: Germany
facility: Community based hemato-oncology medical office
city: Bad Neustadt An Der Saale
country: Germany
facility: Rhön-Saale-Klinik gGmbH
city: Berlin
country: Germany
facility: Community based hemato-oncology medical office
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bremen
country: Germany
facility: Community based hemato-oncology medical office
city: Celle
country: Germany
facility: Community based hemato-oncology medical office
city: Cottbus
country: Germany
facility: Community based hemato-oncology medical office
city: Darmstadt
country: Germany
facility: Community based hemato-oncology medical office
city: Dresden
country: Germany
facility: Community based hemato-oncology medical office
city: Duisburg
country: Germany
facility: Community based hemato-oncology medical office
city: Duisburg
country: Germany
facility: Klinik Duisburg-West
city: Düsseldorf
country: Germany
facility: Universitätsklinik Düsseldorf
city: Ehingen
country: Germany
facility: Community based hemato-oncology medical office
city: Erlangen
country: Germany
facility: Community based hemato-oncology medical office
city: Frankfurt
country: Germany
facility: Community based hemato-oncology medical office
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
city: Freiburg
country: Germany
facility: Community based hemato-oncology medical office
city: Friedrichshafen
country: Germany
facility: Community based hemato-oncology medical office
city: Fürth
country: Germany
facility: Community based hemato-oncology medical office
city: Germering
country: Germany
facility: Community based hemato-oncology medical office
city: Gießen
country: Germany
facility: Community based hemato-oncology medical office
city: Gießen
country: Germany
facility: University Clinic | Medicinal Clinic IV
city: Hagen
country: Germany
facility: St.-Marien-Hospital
city: Halle
country: Germany
facility: Community based hemato-oncology medical office
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus
city: Hanau
country: Germany
facility: Community based hemato-oncology medical office
city: Heidelberg
country: Germany
facility: Community based hemato-oncology medical office
city: Herne
country: Germany
facility: Community based hemato-oncology medical office
city: Herne
country: Germany
facility: Marienkrankenhaus
city: Homberg
country: Germany
facility: Community based hemato-oncology medical office
city: Kaiserslautern
country: Germany
facility: Community based hemato-oncology medical office
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum
city: Kassel
country: Germany
facility: Community based hemato-oncology medical office
city: Kempten
country: Germany
facility: Klinikum Kempten-Oberallgäu
city: Koblenz
country: Germany
facility: Community based hemato-oncology medical office
city: Krefeld
country: Germany
facility: Community based hemato-oncology medical office
city: Kronach
country: Germany
facility: Community based hemato-oncology medical office
city: Landau
country: Germany
facility: Community based hemato-oncology medical office
city: Landshut
country: Germany
facility: Community based hemato-oncology medical office
city: Landshut
country: Germany
facility: Community based hemato-oncology medical office
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen GmbH
city: Ludwigshafen
country: Germany
facility: St. Marienkrankenhaus
city: Lüdenscheid
country: Germany
facility: Community based hemato-oncology medical office
city: Mainz
country: Germany
facility: Universitätsklinik Mainz
city: Marburg
country: Germany
facility: Community based hemato-oncology medical office
city: Mönchengladbach
country: Germany
facility: Community based hemato-oncology medical office
city: München
country: Germany
facility: Community based hemato-oncology medical office
city: München
country: Germany
facility: University Clinic Großhadern
city: Neumarkt
country: Germany
facility: Community based hemato-oncology medical office
city: Nürnberg
country: Germany
facility: Community based hemato-oncology medical office
city: Nürnberg
country: Germany
facility: Community based hemato-oncology medical office
city: Oberhausen
country: Germany
facility: St. Clemens Hospital
city: Olpe
country: Germany
facility: St. Martinus-Hospital
city: Osnabrück
country: Germany
facility: Community based hemato-oncology medical office
city: Potsdam
country: Germany
facility: St. Josefs-Krankenhaus
city: Rehling
country: Germany
facility: Community based hemato-oncology medical office
city: Rüsselsheim
country: Germany
facility: Community based hemato-oncology medical office
city: Saarbrücken
country: Germany
facility: Caritas Klinik St. Theresia
city: Schkeuditz
country: Germany
facility: Community based hemato-oncology medical office
city: Schotten
country: Germany
facility: Kreiskrankenhaus Schotten
city: Schweinfurt
country: Germany
facility: Community based hemato-oncology medical office
city: Siegen
country: Germany
facility: Community based hemato-oncology medical office
city: Siegen
country: Germany
facility: St.-Marien-Krankenhaus
city: Stuttgart
country: Germany
facility: Diakonie - Klinikum Stuttgart
city: Trier
country: Germany
facility: Community based hemato-oncology medical office
city: Tübingen
country: Germany
facility: Community based hemato-oncology medical office
city: Ulm
country: Germany
facility: University Clinic Ulm
city: Villingen-Schwenningen
country: Germany
facility: Städtisches Krankenhaus Villingen
city: Weilheim
country: Germany
facility: Community based hemato-oncology medical office
city: Weimar
country: Germany
facility: Sophien- und Hufeland Klinikum
city: Westerland
country: Germany
facility: Asklepios Nordseeklinik
city: Wiesbaden
country: Germany
facility: Community based hemato-oncology medical office
city: Wiesbaden
country: Germany
facility: Dr. Horst-Schmidt-Kliniken
city: Wilhelmshaven
country: Germany
facility: Community based hemato-oncology medical office
city: Wolfsburg
country: Germany
facility: Community based hemato-oncology medical office
Study officials:
affiliation: Justus-Liebig-University | University Hospital | Medicinal Clinic IV
name: Mathias J Rummel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: