Therapy Optimisation for the Treatment of Hairy Cell Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02131753|
Recruitment Status : Recruiting
First Posted : May 6, 2014
Last Update Posted : April 19, 2019
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|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- 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?
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 firstname.lastname@example.org|
|Contact: Juergen Barth||+4964198542 ext email@example.com|
|Principal Investigator:||Mathias J Rummel, Prof. Dr.||Justus-Liebig-University | University Hospital | Medicinal Clinic IV|