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

Sponsor
Jurgen Barth
Study ID
NCT02157181
Phase
PHASE2
Status
Completed

Conditions

  • Hairy Cell Leukemia (HCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • 2CdA +/- Rituximab — DRUG
    Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion

Study Details

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

Key Dates

Start date
Jun 30, 2004
Status verified
Aug 2024
Primary completion
Sep 30, 2012
Completion
Jan 31, 2013

Study Design

Enrollment
89 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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

Primary Outcome Measure

Rate of complete remissions (CR) [ Time Frame: 4 months after treatment ]

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