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

NCT ID: NCT02157181

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2013-01-31

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.

Conditions

Hairy Cell Leukemia (HCL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HCL, 2CdA +/- Rituximab

Risk stratification

1. HCL variant will be treated with cladribine plus rituximab, independent of previous therapy

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

3. 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

4. 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

Group Type: EXPERIMENTAL

2CdA +/- Rituximab

Intervention Type: DRUG

Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion

Interventions

2CdA +/- Rituximab

Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion

Intervention Type: DRUG

Other Intervention Names

Cladribine, Syn 2CdA, (LITAK®) 0.14 mg/kg; Rituximab (Mabthera®; Rituxan®) 375 mg/m²

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jurgen Barth

OTHER

Sponsor Role: lead

Responsible Party

Jurgen Barth

Professor Dr. med Mathias Rummel

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mathias J Rummel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Justus-Liebig-University | University Hospital | Medicinal Clinic IV

Locations

Klinikum Idar-Oberstein

Idar-Oberstein, , Germany

Community based hemato-oncology medical office

Jena, , Germany

Community based hemato-oncology medical office

Kassel, , Germany

Community based hemato-oncology medical office

Ansbach, , Germany

Community based hemato-oncology medical office

Aschaffenburg, , Germany

Community based hemato-oncology medical office

Celle, , Germany

St.-Johannes-Hospital

Dortmund, , Germany

Städtische Kliniken Esslingen

Esslingen am Neckar, , Germany

Universitätsklinik Frankfurt

Frankfurt am Main, , Germany

Universitätsklinik Freiburg

Freiburg im Breisgau, , Germany

Community based hemato-oncology medical office

Fürth, , Germany

University Clinic | Med. Cinic IV Justus-Liebig-University

Giessen, , Germany

Wilhelm-Anton-Hospital

Goch, , Germany

Kath. Krankenhaus Hagen gem. GmbH

Hagen, , Germany

Community based hemato-oncology medical office

Halle, , Germany

Community based hemato-oncology medical office

Hamburg, , Germany

Meditinische Hochschule (MHH)

Hanover, , Germany

Community based hemato-oncology medical office

Heidelberg, , Germany

Marienhospital Herne/ Klinikum der Ruhr-Universität Bochum

Herne, , Germany

Community based hemato-oncology medical office

Hilden, , Germany

Community based hemato-oncology medical office

Hildesheim, , Germany

Community based hemato-oncology medical office

Kiel, , Germany

Community based hemato-oncology medical office

Koblenz, , Germany

Community based hemato-oncology medical office

Kronach, , Germany

Community based hemato-oncology medical office

Leer, , Germany

Community based hemato-oncology medical office

Leipzig, , Germany

Städtische Kliniken

Leverkusen, , Germany

Community based hemato-oncology medical office

Magdeburg, , Germany

Community based hemato-oncology medical office

Marburg, , Germany

Klinik Schwäbisch Gmünd / Staufer Klinik

Mutlangen, , Germany

Community based hemato-oncology medical office

München, , Germany

Community based hemato-oncology medical office

München, , Germany

Klinikum Großhadern

München, , Germany

Community based hemato-oncology medical office

Neunkirchen, , Germany

Community based hemato-oncology medical office

Neuwied, , Germany

Community based hemato-oncology medical office

Niddatal, , Germany

Community based hemato-oncology medical office

Nuremberg, , Germany

MVZ Klinikum Osnabrück

Osnabrück, , Germany

Community based hemato-oncology medical office

Pforzheim, , Germany

Klinikum Ernst von Bergmann gGmbH

Potsdam, , Germany

St. Josefs-Krankenhaus

Potsdam, , Germany

Community based hemato-oncology medical office

Schweinfurt, , Germany

St. Marien-Krankenhaus

Siegen, , Germany

Community based hemato-oncology medical office

Straubing, , Germany

Diakonie-Klinikum Stuttgart

Stuttgart, , Germany

Community based hemato-oncology medical office

Villingen, , Germany

Community based hemato-oncology medical office

Wolfsburg, , Germany

Countries

Germany

Other Identifiers

NHL 4-2004

Identifier Type: -

Identifier Source: org_study_id