An Open Label, Phase 2 Clinical Trial of MEN1703 as Monotherapy and in Combination with Glofitamab in Patients with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)

Conditions

Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

Brief summary

• Group 1 and 2: Incidence and severity of adverse events (AE), • Group 1: Complete Response (CR) rate, assessed by Independent Review Committee (IRC) following the Lugano Classification (see Section 16), • Group 2: Over all response rate (ORR), assessed by Independent Review Committee (IRC) following the Lugano Classification (see Section 16 of the protocol)

Detailed description

• Group 1: Complete Response (CR) rate, assessed locally following the Lugano classification (see Section 16), • Group 2: Overall Response Rate (ORR), assessed locally following the Lugano classification (see Section 16 of the protocol), • Group 1: The following endpoint measures are assessed by IRC and locally following the Lugano Classification (see Section 16): Overall Response Rate (ORR); Duration of Response (DoR); Duration of Complete Response (DoCR); Progression-free survival (PFS); Overall survival (OS); Time to response; Time to next treatment), • Group 2: The following endpoint measures are assessed by IRC and locally following the Lugano Classification (see Section 16 of the protocol): Complete Response (CR) Rate; Duration of Response (DoR); Duration of Complete Response (DoCR); Progression-free survival (PFS); Overall survival (OS); Time to response; Time to next treatment), • Group 1 and 2: Incidence and severity of AEs; PK of MEN1703 including Cmax, tmax, AUCtau, AUCinf, and t½; Changes in lymphoma symptoms, well-being, and general health status measured by FACT–Lym and EORTC QLQ C30

Related papers

No related papers found yet.

Interventions

DRUGColumvi 10 mg concentrate for solution for infusion

DRUGMEN1703 oral capsule 100 mg

DRUGMEN1703 oral capsule 25 mg

DRUGGazyvaro 1

DRUG000 mg concentrate for solution for infusion.

DRUGColumvi 2.5 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Group 1 and 2: Incidence and severity of adverse events (AE), • Group 1: Complete Response (CR) rate, assessed by Independent Review Committee (IRC) following the Lugano Classification (see Section 16), • Group 2: Over all response rate (ORR), assessed by Independent Review Committee (IRC) following the Lugano Classification (see Section 16 of the protocol)	—

Secondary

Measure	Time frame
• Group 1: Complete Response (CR) rate, assessed locally following the Lugano classification (see Section 16), • Group 2: Overall Response Rate (ORR), assessed locally following the Lugano classification (see Section 16 of the protocol), • Group 1: The following endpoint measures are assessed by IRC and locally following the Lugano Classification (see Section 16): Overall Response Rate (ORR); Duration of Response (DoR); Duration of Complete Response (DoCR); Progression-free survival (PFS); Overall survival (OS); Time to response; Time to next treatment), • Group 2: The following endpoint measures are assessed by IRC and locally following the Lugano Classification (see Section 16 of the protocol): Complete Response (CR) Rate; Duration of Response (DoR); Duration of Complete Response (DoCR); Progression-free survival (PFS); Overall survival (OS); Time to response; Time to next treatment), • Group 1 and 2: Incidence and severity of AEs; PK of MEN1703 including Cmax, tmax, AUCtau, AUCinf,	—

Measure

Time frame

• Group 1: Complete Response (CR) rate, assessed locally following the Lugano classification (see Section 16), • Group 2: Overall Response Rate (ORR), assessed locally following the Lugano classification (see Section 16 of the protocol), • Group 1: The following endpoint measures are assessed by IRC and locally following the Lugano Classification (see Section 16): Overall Response Rate (ORR); Duration of Response (DoR); Duration of Complete Response (DoCR); Progression-free survival (PFS); Overall survival (OS); Time to response; Time to next treatment), • Group 2: The following endpoint measures are assessed by IRC and locally following the Lugano Classification (see Section 16 of the protocol): Complete Response (CR) Rate; Duration of Response (DoR); Duration of Complete Response (DoCR); Progression-free survival (PFS); Overall survival (OS); Time to response; Time to next treatment), • Group 1 and 2: Incidence and severity of AEs; PK of MEN1703 including Cmax, tmax, AUCtau, AUCinf,

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Countries

France, Poland, Spain

Outcome results

None listed