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

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ClinicalTrials.gov Identifier: NCT02157181
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Information provided by (Responsible Party):
Jurgen Barth, University of Giessen

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


Condition or disease Intervention/treatment Phase
Hairy Cell Leukemia (HCL) Drug: 2CdA +/- Rituximab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia
Study Start Date : June 2004
Actual Primary Completion Date : September 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
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

Drug: 2CdA +/- Rituximab
Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion
Other Names:
  • Cladribine, Syn 2CdA, (LITAK®) 0.14 mg/kg
  • Rituximab (Mabthera®; Rituxan®) 375 mg/m²




Primary Outcome Measures :
  1. Rate of complete remissions (CR) [ Time Frame: 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 :
  1. Overall remission rate (ORR) [ Time Frame: 4 months after treatment ]
    The rate of CR + PR will be determined


Other Outcome Measures:
  1. Acute and late toxicity [ Time Frame: From day 1 of treatment period up to 120 months ]
    All kind of adverse events, laboratory abnormalities, infections, unplanned hospitalisations will be measured

  2. Degree of induced immunodeficiency [ Time Frame: From day 1 of treatment period up to 120 months ]

    Degree of immunosupression with CD4/CD8 quotient as indicating biomarker will be measured.

    Duration of immunosupression as well as infectious and other complications which result from therapy will be reported


  3. Frequency of secondary neoplasia during the life-long follow-up period [ Time Frame: From day 1 of treatment period up to 120 months ]
    Rate of secondary neoplasia as safety issue will be determined

  4. Overall survival (OS) [ Time Frame: From achieving a remission until death ]
    Determination of the overall survival times of all patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157181


Locations
Show Show 47 study locations
Sponsors and Collaborators
Jurgen Barth
Investigators
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Principal Investigator: Mathias J Rummel, Prof. Dr. Justus-Liebig-University | University Hospital | Medicinal Clinic IV
Additional Information:
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Responsible Party: Jurgen Barth, Professor Dr. med Mathias Rummel, University of Giessen
ClinicalTrials.gov Identifier: NCT02157181    
Other Study ID Numbers: NHL 4-2004
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: June 5, 2014
Last Verified: June 2014
Keywords provided by Jurgen Barth, University of Giessen:
HCL variant
HCL relapse
Risk stratified
Additional relevant MeSH terms:
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Leukemia
Leukemia, Hairy Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Cladribine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents