Clinical trial NCT02157181: Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab
Official title: Study on the Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hairy Cell Leukemia (HCL)
Keywords: HCL variant
HCL relapse
Risk stratified
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 89
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 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

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 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

Primary outcomes:
measure: Rate of complete remissions (CR)
timeFrame: 4 months after treatment
Secondary outcomes:
measure: Overall remission rate (ORR)
timeFrame: 4 months after treatment
Other outcomes:
measure: Acute and late toxicity
timeFrame: From day 1 of treatment period up to 120 months
measure: Degree of induced immunodeficiency
timeFrame: From day 1 of treatment period up to 120 months
measure: Frequency of secondary neoplasia during the life-long follow-up period
timeFrame: From day 1 of treatment period up to 120 months
measure: Overall survival (OS)
timeFrame: From achieving a remission until death
Locations:
city: Ansbach
country: Germany
facility: Community based hemato-oncology medical office
city: Aschaffenburg
country: Germany
facility: Community based hemato-oncology medical office
city: Celle
country: Germany
facility: Community based hemato-oncology medical office
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital
city: Esslingen
country: Germany
facility: Städtische Kliniken Esslingen
city: Frankfurt am Main
country: Germany
facility: Universitätsklinik Frankfurt
city: Freiburg
country: Germany
facility: Universitätsklinik Freiburg
city: Fürth
country: Germany
facility: Community based hemato-oncology medical office
city: Gießen
country: Germany
facility: University Clinic | Med. Cinic IV Justus-Liebig-University
city: Goch
country: Germany
facility: Wilhelm-Anton-Hospital
city: Hagen
country: Germany
facility: Kath. Krankenhaus Hagen gem. GmbH
city: Halle
country: Germany
facility: Community based hemato-oncology medical office
city: Hamburg
country: Germany
facility: Community based hemato-oncology medical office
city: Hannover
country: Germany
facility: Meditinische Hochschule (MHH)
city: Heidelberg
country: Germany
facility: Community based hemato-oncology medical office
city: Herne
country: Germany
facility: Marienhospital Herne/ Klinikum der Ruhr-Universität Bochum
city: Hilden
country: Germany
facility: Community based hemato-oncology medical office
city: Hildesheim
country: Germany
facility: Community based hemato-oncology medical office
city: Idar-Oberstein
country: Germany
facility: Klinikum Idar-Oberstein
city: Jena
country: Germany
facility: Community based hemato-oncology medical office
city: Kassel
country: Germany
facility: Community based hemato-oncology medical office
city: Kiel
country: Germany
facility: Community based hemato-oncology medical office
city: Koblenz
country: Germany
facility: Community based hemato-oncology medical office
city: Kronach
country: Germany
facility: Community based hemato-oncology medical office
city: Leer
country: Germany
facility: Community based hemato-oncology medical office
city: Leipzig
country: Germany
facility: Community based hemato-oncology medical office
city: Leverkusen
country: Germany
facility: Städtische Kliniken
city: Magdeburg
country: Germany
facility: Community based hemato-oncology medical office
city: Marburg
country: Germany
facility: Community based hemato-oncology medical office
city: Mutlangen
country: Germany
facility: Klinik Schwäbisch Gmünd / Staufer Klinik
city: München
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: Klinikum Großhadern
city: Neunkirchen
country: Germany
facility: Community based hemato-oncology medical office
city: Neuwied
country: Germany
facility: Community based hemato-oncology medical office
city: Niddatal
country: Germany
facility: Community based hemato-oncology medical office
city: Nürnberg
country: Germany
facility: Community based hemato-oncology medical office
city: Osnabrück
country: Germany
facility: MVZ Klinikum Osnabrück
city: Pforzheim
country: Germany
facility: Community based hemato-oncology medical office
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann gGmbH
city: Potsdam
country: Germany
facility: St. Josefs-Krankenhaus
city: Schweinfurt
country: Germany
facility: Community based hemato-oncology medical office
city: Siegen
country: Germany
facility: St. Marien-Krankenhaus
city: Straubing
country: Germany
facility: Community based hemato-oncology medical office
city: Stuttgart
country: Germany
facility: Diakonie-Klinikum Stuttgart
city: Villingen
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: