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Association details:
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Safety and efficacy of parsaclisib in combination with obinutuzumab and bendamustine in patients with relapsed or refractory follicular lymphoma (CITADEL-102): A phase 1 study

Published date:
07/26/2023
Excerpt:
Patients were ≥18 years of age with histologically confirmed and documented CD20-positive FL...Seventeen patients (65.4%) had a complete response and 3 patients (11.5%) had a partial response, for an objective response rate of 76.9%. Overall, results from CITADEL-102 suggest that the combination of parsaclisib with obinutuzumab and bendamustine... demonstrated preliminary efficacy in patients with R/R FL who progressed following prior rituximab-containing regimens.
Secondary therapy:
bendamustine
DOI:
10.1002/hon.3209
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A PHASE 1 STUDY EVALUATING SAFETY AND EFFICACY OF PARSACLISIB IN COMBINATION WITH BENDAMUSTINE + OBINUTUZUMAB IN PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (CITADEL-102)

Published date:
05/12/2022
Excerpt:
Pts enrolled were ≥18 years with histologically confirmed CD20-positive FL, R/R to any prior rituximab-containing regimen, ECOG PS 0–2, ≥1 measurable lesion, and ≤4 prior therapies. Pts received parsaclisib 20 mg orally once daily (QD) for 8 weeks then 20 mg once weekly (QW); bendamustine 90 mg/m2 infusion on days 1 and 2 of cycles 1–6; and obinutuzumab 1000 mg infusion on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2–6...ORR (95% CI) as reported by the investigator was 76.9% (56.4–91.0), with 17 pts (65.4%) achieving CR/CMR and 3 pts (11.5%) achieving PR/PMR as the best overall response. Median DOR, PFS, and OS were not reached.
Secondary therapy:
bendamustine
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

522 - A Phase 1 Study Evaluating Safety and Efficacy of Parsaclisib in Combination with Bendamustine + Obinutuzumab in Patients with Relapsed or Refractory Follicular Lymphoma (R/R FL) (CITADEL-102)

Published date:
02/11/2022
Excerpt:
Pts ≥18 years must have had histologically confirmed CD20-positive FL, R/R to any prior rituximab-containing regimen, ECOG PS 0–2, ≥1 measurable lesion, and ≤4 prior therapies. Pts received parsaclisib 20 mg once daily (QD) for 8 weeks then 20 mg once weekly (QW); bendamustine 90 mg/m2 infusion on days 1 and 2 of cycles 1–6; and obinutuzumab 1000 mg infusion on days 1, 8, and 15...ORR (95% CI) as reported by the investigator was 76.9% (56.4–91.0), with 17 pts (65.4%) achieving CR/CMR and 3 pts (11.5%) achieving PR/PMR as the best overall response.
Secondary therapy:
bendamustine
Trial ID: