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Trial record 1 of 1 for:    NHL 3-2004
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Therapy Optimisation for the Treatment of Hairy Cell Leukemia

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ClinicalTrials.gov Identifier: NCT02131753
Recruitment Status : Recruiting
First Posted : May 6, 2014
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle of cladribine in patients with hairy cell leukemia requiring treatment.

They have to be untreated so far or may be pretreated with alpha-interferon.


Condition or disease Intervention/treatment Phase
Hairy Cell Leukemia Drug: Cladribine s.c. injection, HCL treatment Phase 2 Phase 3

Detailed Description:

Evaluation of remission status will take place 4 months after treatment. In addition, it will be tested whether patients with non-optimal response will have a benefit from a second cycle of cladribine.

Non-optimal response is: patients with detectable residual disease; achievement of partial remission or detectable residual infiltration in the bone marrow.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapy Optimisation for the Treatment of Hairy Cell Leukemia
Study Start Date : May 2004
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Cladribine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Cladribine s.c. injection, HCL treatment
Cladribine 0.14 mg/kg body weight for 5 consecutive days (d 1 - 5) as subcutaneous bolus injection for patients with hairy cell leukemia needing treatment
Drug: Cladribine s.c. injection, HCL treatment
Patients with hairy cell leukemia and the need for treatment are given cladribine 0.14 mg/kg for 5 consecutive days as a s. c bolus injection
Other Names:
  • Litak(R)
  • 2-CdA


Outcome Measures

Primary Outcome Measures :
  1. Determination of the rate of complete remissions after one cycle with subcutaneous cladribine [ Time Frame: 4 months after treatment ]

Secondary Outcome Measures :
  1. Rate of complete remissions in patient who still have detectable residual disease [ Time Frame: 4 months after treatment ]
    A second cycle of cladribine after an interval of 4 months following the first cycle.


Other Outcome Measures:
  1. Overall effectiveness [ Time Frame: 20 years ]

    Determination of:

    • overall remission rate
    • duration of remission
    • immunodeficiency induced by treatment, its duration, infectious and other complications resulting from that
    • frequency of secondary neoplasia during life long follow up
    • overall survival

  2. Improvement of remission deepness [ Time Frame: Date of staging after first cycle + 4 months ]
    Can a complete remission be achieved with a second cycle in patients who have achieved only a partial remission after one cycle?

  3. Improvement of remission quality [ Time Frame: Date of staging after first cycle + 4 months ]
    Can the quality of remission achieved with the first cycle be improved with a second cycle?

  4. Lowering risk of relapse [ Time Frame: Date of proven remission until the date of firdt documented progression or date of death from any cause, whichever came first, assessed up to 20 years ]
    Can the expected risk of relapse be lowered and the duration of remission be prolonged?


Eligibility Criteria

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

Inclusion Criteria:

  • Patients with histologically verified hairy cell leukemia
  • Presence of hairy cells in the bone marrow and peripheral blood detected by positive TRAP staining and / or co expression if cell surface antigens cluster of differentiation (CD) 19/CD25 or CD19/CD103 (b-ly7)
  • No previous cytostatic treatment (splenectomy or interferon treatment are allowed)
  • Need for treatment
  • Age at least 18 years old
  • General state of health according to WHO 0-2
  • Current histology, not older than 6 months
  • Written consent by patient

Exclusion Criteria:

  • Patients not fulfilling inclusion criteria above
  • Hairy cell leukemia variants (HCL-V): presence of lymphoid cells in bone marrow and / or peripheral blood, which have an intermediate morphology between hairy cells and prolymphocytes (negative TRAP staining and co- expression of CD19/CD103 without CD25
  • Pretreatment with purine analogues or other chemotherapeutics
  • Concomitant corticosteroid therapy
  • Severe dysfunction of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver, except due to lymphoma (bilirubin > 2 mg/dl, alkaline phosphatase, glutamate-oxalacetate transaminase and glutamate-pyruvate transaminase > 2 x upper limit of normal), the kidneys (creatinin > 2 mg/dl or creatinine clearance < 50 ml/min), central nervous system diseases including psychoses.
  • Proven HIV infection
  • Active Hepatitis
  • Other florid infections
  • Anamnesis / diagnosis of other malignant disease (other than non-melanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
  • Pregnant or lactating women
Contacts and Locations

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): NCT02131753


Contacts
Contact: Mathias J Rummel, Prof PhD +4964198542 ext 650 mathias.rummel@innere.med.uni-giessen.de
Contact: Juergen Barth +4964198542 ext 603 juergen.barth@innere.med.uni-giessen.de

  Show 76 Study Locations
Sponsors and Collaborators
University of Giessen
Investigators
Principal Investigator: Mathias J Rummel, Prof. Dr. Justus-Liebig-University | University Hospital | Medicinal Clinic IV
More Information

Additional Information:
Responsible Party: Jurgen Barth, Head of StiL Coordinating Center, University of Giessen
ClinicalTrials.gov Identifier: NCT02131753     History of Changes
Other Study ID Numbers: NHL 3-2004
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jurgen Barth, University of Giessen:
hairy cell leukemia
untreated
cladribine subcutaneous

Additional relevant MeSH terms:
Leukemia
Leukemia, Hairy Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cladribine
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs