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
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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 |
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Hairy Cell Leukemia | Drug: Cladribine s.c. injection, HCL treatment | Phase 2 Phase 3 |
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 210 participants |
Allocation: | N/A |
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 2025 |
Estimated Study Completion Date : | December 2027 |
Arm | Intervention/treatment |
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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
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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:
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- Determination of the rate of complete remissions after one cycle with subcutaneous cladribine [ Time Frame: 4 months after treatment ]
- 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.
- 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?
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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 |
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
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
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 |
Principal Investigator: | Mathias J Rummel, Prof. Dr. | Justus-Liebig-University | University Hospital | Medicinal Clinic IV |
Responsible Party: | Jurgen Barth, Head of StiL Coordinating Center, University of Giessen |
ClinicalTrials.gov Identifier: | NCT02131753 |
Other Study ID Numbers: |
NHL 3-2004 |
First Posted: | May 6, 2014 Key Record Dates |
Last Update Posted: | May 10, 2023 |
Last Verified: | May 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
hairy cell leukemia untreated cladribine subcutaneous |
Leukemia Leukemia, Hairy Cell Neoplasms by Histologic Type Neoplasms Hematologic Diseases Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Cladribine Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |