Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Hairy Cell Leukemia Clinical Trial

Official title:

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02131753
• Other study ID #: NHL 3-2004
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 2004
• Est. completion date: December 2027

Study information

• Verified date: May 2023
• Source: University of Giessen
• Contact: Mathias J Rummel, Prof PhD
• Phone: +4964198542
• Email: mathias.rummel[@]innere.med.uni-giessen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hairy Cell Leukemia
• Leukemia
• Leukemia, Hairy Cell

Intervention

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

Locations

Country	Name	City	State
Germany	Community based hemato-oncology medical office	Ansbach
Germany	Community based hemato-oncology medical office	Aschaffenburg
Germany	Rhön-Saale-Klinik gGmbH	Bad Neustadt An Der Saale
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Community based hemato-oncology medical office	Berlin
Germany	Community based hemato-oncology medical office	Bremen
Germany	Community based hemato-oncology medical office	Celle
Germany	Community based hemato-oncology medical office	Cottbus
Germany	Community based hemato-oncology medical office	Darmstadt
Germany	Community based hemato-oncology medical office	Dresden
Germany	Community based hemato-oncology medical office	Duisburg
Germany	Klinik Duisburg-West	Duisburg
Germany	Universitätsklinik Düsseldorf	Düsseldorf
Germany	Community based hemato-oncology medical office	Ehingen
Germany	Community based hemato-oncology medical office	Erlangen
Germany	Community based hemato-oncology medical office	Frankfurt
Germany	Krankenhaus Nordwest	Frankfurt
Germany	Community based hemato-oncology medical office	Freiburg
Germany	Community based hemato-oncology medical office	Friedrichshafen
Germany	Community based hemato-oncology medical office	Fürth
Germany	Community based hemato-oncology medical office	Germering
Germany	Community based hemato-oncology medical office	Gießen
Germany	University Clinic | Medicinal Clinic IV	Gießen
Germany	St.-Marien-Hospital	Hagen
Germany	Community based hemato-oncology medical office	Halle
Germany	Evangelisches Krankenhaus	Hamm
Germany	Community based hemato-oncology medical office	Hanau
Germany	Community based hemato-oncology medical office	Heidelberg
Germany	Community based hemato-oncology medical office	Herne
Germany	Marienkrankenhaus	Herne
Germany	Community based hemato-oncology medical office	Homberg
Germany	Community based hemato-oncology medical office	Kaiserslautern
Germany	Städtisches Klinikum	Karlsruhe
Germany	Community based hemato-oncology medical office	Kassel
Germany	Klinikum Kempten-Oberallgäu	Kempten
Germany	Community based hemato-oncology medical office	Koblenz
Germany	Community based hemato-oncology medical office	Krefeld
Germany	Community based hemato-oncology medical office	Kronach
Germany	Community based hemato-oncology medical office	Landau
Germany	Community based hemato-oncology medical office	Landshut
Germany	Community based hemato-oncology medical office	Landshut
Germany	Klinikum Leverkusen GmbH	Leverkusen
Germany	Community based hemato-oncology medical office	Lüdenscheid
Germany	St. Marienkrankenhaus	Ludwigshafen
Germany	Universitätsklinik Mainz	Mainz
Germany	Community based hemato-oncology medical office	Marburg
Germany	Community based hemato-oncology medical office	Mönchengladbach
Germany	Community based hemato-oncology medical office	München
Germany	University Clinic Großhadern	München
Germany	Community based hemato-oncology medical office	Neumarkt
Germany	Community based hemato-oncology medical office	Nürnberg
Germany	Community based hemato-oncology medical office	Nürnberg
Germany	St. Clemens Hospital	Oberhausen
Germany	St. Martinus-Hospital	Olpe
Germany	Community based hemato-oncology medical office	Osnabrück
Germany	St. Josefs-Krankenhaus	Potsdam
Germany	Community based hemato-oncology medical office	Rehling
Germany	Community based hemato-oncology medical office	Rüsselsheim
Germany	Caritas Klinik St. Theresia	Saarbrücken
Germany	Community based hemato-oncology medical office	Schkeuditz
Germany	Kreiskrankenhaus Schotten	Schotten
Germany	Community based hemato-oncology medical office	Schweinfurt
Germany	Community based hemato-oncology medical office	Siegen
Germany	St.-Marien-Krankenhaus	Siegen
Germany	Diakonie - Klinikum Stuttgart	Stuttgart
Germany	Community based hemato-oncology medical office	Trier
Germany	Community based hemato-oncology medical office	Tübingen
Germany	University Clinic Ulm	Ulm
Germany	Städtisches Krankenhaus Villingen	Villingen-Schwenningen
Germany	Community based hemato-oncology medical office	Weilheim
Germany	Sophien- und Hufeland Klinikum	Weimar
Germany	Asklepios Nordseeklinik	Westerland
Germany	Community based hemato-oncology medical office	Wiesbaden
Germany	Dr. Horst-Schmidt-Kliniken	Wiesbaden
Germany	Community based hemato-oncology medical office	Wilhelmshaven
Germany	Community based hemato-oncology medical office	Wolfsburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall effectiveness	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	20 years
Other	Improvement of remission deepness	Can a complete remission be achieved with a second cycle in patients who have achieved only a partial remission after one cycle?	Date of staging after first cycle + 4 months
Other	Improvement of remission quality	Can the quality of remission achieved with the first cycle be improved with a second cycle?	Date of staging after first cycle + 4 months
Other	Lowering risk of relapse	Can the expected risk of relapse be lowered and the duration of remission be prolonged?	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
Primary	Determination of the rate of complete remissions after one cycle with subcutaneous cladribine		4 months after treatment
Secondary	Rate of complete remissions in patient who still have detectable residual disease	A second cycle of cladribine after an interval of 4 months following the first cycle.	4 months after treatment

External Links

•   Homepage of StiL = Study group indolent Lymphomas