Assessment of Disease Burden in Hairy Cell Leukemia
ConditionHairy Cell Leukemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
Drug-free, single-center, prospective observational pilot study in hairy Cell Leukemia patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
newly diagnosed and candidates for first-line cytoreductive treatment with analogues purines or
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
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).
Age ≥ 18 years at enrollment
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Peripheral and BM blood sample
Other interventionPeripheral and BM blood samples will be analyzed with the ddPCR method
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: HCL, B-raf V600E-mutated patientsOther 1 intervention
Trial outcomes
Primary outcomes
1
Progression Free Survival (PFS)
Progression Free Survival (PFS)
Time frame
through study completion, an average of 4 years2
Time to next treatment
Time to next treatment
Time frame
through study completion, an average of 4 years3
Correlation between the share of mutated allele (fractional abundance) with the response to the treatment.Correlation between the share of mutated allele (fractional abundance) with the response to the treatment.
Correlation between the share of mutated allele (fractional abundance) with the response
Time frame
through study completion, an average of 4 yearsSecondary outcomes
1
mutational pattern of B-raf i
Evaluation of the mutational pattern of B-raf in patients with HCL in long hematological response
Time frame
through study completion, an average of 4 yearsSponsors and contacts
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Source ClinicalTrials.gov