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

Phase 2

Completed

• Conditions: Hairy Cell Leukemia (HCL)
• Interventions: Drug: 2CdA +/- Rituximab

• Registration Number: NCT02157181
• Lead Sponsor: Jurgen Barth

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.

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2012-09
• Study Completion: 2013-01
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCL, 2CdA +/- Rituximab	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

Primary Outcome Measures

Name	Time	Method
Rate of complete remissions (CR)	4 months after treatment	Determination of the rate of complete remission and duration of remission after one cycle of subcutaneous cladribine (LITAK®) plus four administrations of rituximab; * in patients with hairy cell leukaemia variant; * in patients with relapsed hairy cell leukaemia

Secondary Outcome Measures

Name	Time	Method
Overall remission rate (ORR)	4 months after treatment	The rate of CR + PR will be determined

Trial Locations

Locations (19)

St. Josefs-Krankenhaus; 🇩🇪 Potsdam, Germany

Community based hemato-oncology medical office; 🇩🇪 Wolfsburg, Germany

Städtische Kliniken; 🇩🇪 Leverkusen, Germany

Klinikum Großhadern; 🇩🇪 München, Germany

MVZ Klinikum Osnabrück; 🇩🇪 Osnabrück, Germany

Klinikum Ernst von Bergmann gGmbH; 🇩🇪 Potsdam, Germany

St. Marien-Krankenhaus; 🇩🇪 Siegen, Germany

Diakonie-Klinikum Stuttgart; 🇩🇪 Stuttgart, Germany

St.-Johannes-Hospital; 🇩🇪 Dortmund, Germany

Städtische Kliniken Esslingen; 🇩🇪 Esslingen, Germany

Universitätsklinik Frankfurt; 🇩🇪 Frankfurt am Main, Germany

University Clinic | Med. Cinic IV Justus-Liebig-University; 🇩🇪 Gießen, Germany

Wilhelm-Anton-Hospital; 🇩🇪 Goch, Germany

Kath. Krankenhaus Hagen gem. GmbH; 🇩🇪 Hagen, Germany

Klinikum Idar-Oberstein; 🇩🇪 Idar-Oberstein, Germany

Klinik Schwäbisch Gmünd / Staufer Klinik; 🇩🇪 Mutlangen, Germany

Meditinische Hochschule (MHH); 🇩🇪 Hannover, Germany

Universitätsklinik Freiburg; 🇩🇪 Freiburg, Germany

Marienhospital Herne/ Klinikum der Ruhr-Universität Bochum; 🇩🇪 Herne, Germany