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NCT Number: NCT02131753

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

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.

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Key information

Conditions

Hairy Cell Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Hairy Cell Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Community based hemato-oncology medical office, Ansbach, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cladribine s.c. injection, HCL treatment

Drug

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

Primary outcomes

  1. Determination of the rate of complete remissions after one cycle with subcutaneous cladribine

    Time frame: 4 months after treatment

Secondary outcomes

  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 outcomes

  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?

Study contacts

Contact information is provided by the study sponsor or research team.

Juergen Barth

CONTACT

[email protected]

+4964198542 ext. 603

Mathias J Rummel, Prof PhD

CONTACT

[email protected]

+4964198542 ext. 650

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Important dates

Study start
2004
Primary completion
2025
Study completion
2027
First posted
May 6, 2014
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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