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

NCT02157181 | Completed Phase 2

• 1 other identifier: NHL 4-2004
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 47

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

Conditions

Hairy Cell Leukemia (HCL)

Keywords

HCL variant; HCL relapse; Risk stratified

Outcome Measures

Primary Outcomes (1)

• Rate of complete remissions (CR)

  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

  4 months after treatment

Secondary Outcomes (1)

• Overall remission rate (ORR)

  4 months after treatment

Other Outcomes (4)

• Acute and late toxicity

  From day 1 of treatment period up to 120 months

• Degree of induced immunodeficiency

  From day 1 of treatment period up to 120 months

• Frequency of secondary neoplasia during the life-long follow-up period

  From day 1 of treatment period up to 120 months

Study Arms (1)

HCL, 2CdA +/- Rituximab

EXPERIMENTAL

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

Drug: 2CdA +/- Rituximab

Interventions

2CdA +/- Rituximab DRUG

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

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

HCL, 2CdA +/- Rituximab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jurgen Barth: lead

Study Sites (47)

Community based hemato-oncology medical office

Ansbach, 91522, Germany

Location

Community based hemato-oncology medical office

Aschaffenburg, 63739, Germany

Location

Community based hemato-oncology medical office

Celle, 29221, Germany

Location

St.-Johannes-Hospital

Dortmund, 44137, Germany

Location

Städtische Kliniken Esslingen

Esslingen am Neckar, 73728, Germany

Location

Universitätsklinik Frankfurt

Frankfurt am Main, 60596, Germany

Location

Universitätsklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Community based hemato-oncology medical office

Fürth, 90766, Germany

Location

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

Giessen, 3592, Germany

Location

Wilhelm-Anton-Hospital

Goch, 47574, Germany

Location

Kath. Krankenhaus Hagen gem. GmbH

Hagen, 58095, Germany

Location

Community based hemato-oncology medical office

Halle, 06108, Germany

Location

Community based hemato-oncology medical office

Hamburg, 21073, Germany

Location

Meditinische Hochschule (MHH)

Hanover, 30623, Germany

Location

Community based hemato-oncology medical office

Heidelberg, 69115, Germany

Location

Marienhospital Herne/ Klinikum der Ruhr-Universität Bochum

Herne, 44625, Germany

Location

Community based hemato-oncology medical office

Hilden, 40721, Germany

Location

Community based hemato-oncology medical office

Hildesheim, 31134, Germany

Location

Klinikum Idar-Oberstein

Idar-Oberstein, 55743, Germany

Location

Community based hemato-oncology medical office

Jena, 07743, Germany

Location

Community based hemato-oncology medical office

Kassel, 34125, Germany

Location

Community based hemato-oncology medical office

Kiel, 24105, Germany

Location

Community based hemato-oncology medical office

Koblenz, 56068, Germany

Location

Community based hemato-oncology medical office

Kronach, 96317, Germany

Location

Community based hemato-oncology medical office

Leer, 26789, Germany

Location

Community based hemato-oncology medical office

Leipzig, 04103, Germany

Location

Städtische Kliniken

Leverkusen, 51375, Germany

Location

Community based hemato-oncology medical office

Magdeburg, 39104, Germany

Location

Community based hemato-oncology medical office

Marburg, 35037, Germany

Location

Klinik Schwäbisch Gmünd / Staufer Klinik

Mutlangen, 73557, Germany

Location

Community based hemato-oncology medical office

München, 80335, Germany

Location

Community based hemato-oncology medical office

München, 81241, Germany

Location

Klinikum Großhadern

München, 81377, Germany

Location

Community based hemato-oncology medical office

Neunkirchen, 66538, Germany

Location

Community based hemato-oncology medical office

Neuwied, 56564, Germany

Location

Community based hemato-oncology medical office

Niddatal, 61194, Germany

Location

Community based hemato-oncology medical office

Nuremberg, 90449, Germany

Location

MVZ Klinikum Osnabrück

Osnabrück, 49076, Germany

Location

Community based hemato-oncology medical office

Pforzheim, 75179, Germany

Location

Klinikum Ernst von Bergmann gGmbH

Potsdam, 14467, Germany

Location

St. Josefs-Krankenhaus

Potsdam, 14471, Germany

Location

Community based hemato-oncology medical office

Schweinfurt, 97421, Germany

Location

St. Marien-Krankenhaus

Siegen, 57072, Germany

Location

Community based hemato-oncology medical office

Straubing, 94315, Germany

Location

Diakonie-Klinikum Stuttgart

Stuttgart, 70176, Germany

Location

Community based hemato-oncology medical office

Villingen, 78050, Germany

Location

Community based hemato-oncology medical office

Wolfsburg, 38440, Germany

Location

MeSH Terms

Conditions

Leukemia, Hairy Cell

Interventions

Cladribine; Rituximab

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mathias J Rummel, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dr. med Mathias Rummel

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: June 5, 2014
• Study Start: June 1, 2004
• Primary Completion: September 1, 2012
• Study Completion: January 1, 2013
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

DE (47)