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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 : May 10, 2023
Sponsor:
Information provided by (Responsible Party):
Jurgen Barth, University of Giessen

Tracking Information
First Submitted Date  ICMJE April 30, 2014
First Posted Date  ICMJE May 6, 2014
Last Update Posted Date May 10, 2023
Study Start Date  ICMJE May 2004
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2014)		 Determination of the rate of complete remissions after one cycle with subcutaneous cladribine [ Time Frame: 4 months after treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2014)		 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 2, 2014)
  • 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
  • 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?
  • 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?
  • 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?
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Therapy Optimisation for the Treatment of Hairy Cell Leukemia
Official Title  ICMJE Therapy Optimisation for the Treatment of Hairy Cell Leukemia
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hairy Cell Leukemia
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Drug: Cladribine s.c. injection, HCL treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2014)		 210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02131753
Other Study ID Numbers  ICMJE NHL 3-2004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jurgen Barth, University of Giessen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Giessen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mathias J Rummel, Prof. Dr. Justus-Liebig-University | University Hospital | Medicinal Clinic IV
PRS Account University of Giessen
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP