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Association details:
| Biomarker: | BRAF V600E |
|---|---|
| Cancer: | Hairy Cell Leukemia |
| Drug: | Zelboraf (vemurafenib) (BRAF inhibitor, BRAF V600E inhibitor) + Rituxan (rituximab) (CD20 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
VEMURAFENIB + RITUXIMAB (VR) AS A CHEMOTHERAPY-FREE ALTERNATIVE TO CLADRIBINE + RITUXIMAB (CDAR) IN FRONT-LINE HAIRY CELL LEUKEMIA (HCL): A PHASE-2 RANDOMIZED MULTICENTER TRIAL VEMURAFENIB + RITUXIMAB (VR) COME ALTERNATIVA NON CHEMIOTERAPICA A CLADRIBINA + RITUXIMAB (CDAR) NEL TRATTAMENTO DI PRIMA LINEA DELLA TRICOLEUCEMIA: UNO STUDIO MULTICENTRICO RANDOMIZZATO DI FASE-2
Excerpt:
...Need of treatment, i.e. at least one of the following: neuthrophils AF-V600E mutation centrally confirmed.10. ...
Trial ID:
Source:
Title:
STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF VEMURAFENIB (ZELBORAF) IN COMBINATION WITH MONOCLONAL ANTIBODY RITUXIMAB (MABTHERA) IN PREVIOUSLY TREATED PATIENTS WITH HAIRY CELL LEUKEMIA (HCL) CARRYING THE BRAF-V600E MUTATION
Excerpt:
...Proven diagnosis of HCL according to the morphological and immunophenotypic criteria (co-expression of CD11c/CD25/CD103 and/or positivity for annexin-A1) of the World Health Organization (WHO-2008) classification of lymphoid neoplasms12, accompanied by the presence of the BRAF-V600E mutation as detected using a sensitive allele-specific polymerase chain reaction (AS-PCR) recently developed in our laboratory. ...
Trial ID:
Less C2 evidence
Source:
Title:
4413 A Single Arm Phase II Pilot Study of Low Dose Vemurafenib Plus Rituximab in the Front-Line and Relapsed/Refractory Treatment of Hairy Cell Leukemia
Published date:
11/02/2023
Excerpt:
In 2 of these patients, MRD assessment by allele-specific PCR for BRAF V600E was absent in the bone marrow. In the third patient, though residual disease was present by MRD assessment, he had a hematologic response and requires no subsequent treatment to date. At a median follow-up time of 303 days, the relapse-free survival rate was 100%...Interim results to-date suggest that rituximab and low-dose vemurafenib (240 mg twice daily) have efficacy and good tolerability in patients with untreated or relapsed HCL.
