Clinical trial · Interventional
Assessment of Disease Burden in Hairy Cell Leukemia
NCT06781515CI-TRIAL-00084822BRAFrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Drug-free, single-center, prospective observational pilot study in hairy Cell Leukemia patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hairy Cell Leukemia | Hairy Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peripheral and BM blood sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- HCL, B-raf V600E-mutated patients
- description
- For each patient only pheripheral and medullary blood sample and medullary biospy will be collected
- interventionNames
- Other: Peripheral and BM blood sample
Primary outcomes (3)
- measure
- Progression Free Survival (PFS)
- timeFrame
- through study completion, an average of 4 years
- description
- Progression Free Survival (PFS)
- measure
- Time to next treatment
- timeFrame
- through study completion, an average of 4 years
- description
- Time to next treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed diagnosis of HCL patients: 1. newly diagnosed and candidates for first-line cytoreductive treatment with analogues purines or 2. in relapse after a previous line of treatment, with indication for rescue therapy (repetition of a purine analogue; use of targeted or innovative drugs), except splenectomy or 3. in CR for at least 5 years after a first line of treatment, in the absence of clinical alterations indicative of a state of hematological relapse, or in any case in the absence of an indication for a new line of cytoreductive therapy (time-to-next treatment exceeding 5 years). 2. Age ≥ 18 years at enrollment 3. Signature of written informed consent Exclusion Criteria: 1\. Concomitant second malignancy.
References
Publications (0)
Data not yet available
No reference posted for this study.