A PHASE 2 MULTICENTER STUDY OF AXICABTAGENE CILOLEUCEL IN SUBJECTS WITH RELAPSED/REFRACTORY INDOLENT NON-HODGKIN LYMPHOMA (INHL)

Conditions

Follicular Lymphoma, Marginal Zone Lymphoma, Indolent Non-Hodgkin Lymphoma

Brief summary

Objective response rate (ORR) per central read for up to 15 years

Detailed description

CR Rate per central read for up to 15 years., DOR for up to 15 years., PFS for up to 15 years., Percentage of Participants Experiencing Treatment-Emergent Adverse Events for up to 15 years., Levels of anti-CD19 CAR T cells in blood at enrollment, Day 7, Week 2, Week 4, Month 3, Month 6, Month 12, Month 18, Month 24, annually up to year 5., Levels of cytokines in serum at enrollment, prior to axicabtagene ciloleucel infusion on Day 0, Day 3, Day 7, Week 2, Week 4., Percentage of Participants experiencing anti-axicabtagene ciloleucel antibodies at Week 4, Month 3, every 3 months up to Month 12., Percentage of Participants Experiencing clinically significant changes in lab values for up to 15 years, Time to next therapy for up to 15 years., Objective response rate among participants with 3 or more lines of prior therapy for up to 15 years., Complete response rate among those participants with 3 or more lines of prior therapy for up to 15 years., Objective Response Rate as Determined by the Investigator Read for up to 15 years., Best Objective Response per Central Read or Investigator Read for up to 15 years., Overall survival for up to 15 years

Related papers

No related papers found yet.

Interventions

DRUGTOCILIZUMAB

DRUGDEXAMETHASONE

DRUGFLUDARABINE

DRUGMETHYLPREDNISOLONE

DRUGCYCLOPHOSPHAMIDE

DRUGDIPHENHYDRAMINE

DRUGMESNA

DRUGYESCARTA 0.4 – 2 x 10e8 cells dispersion for infusion

DRUGPARACETAMOL

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) per central read for up to 15 years	—

Secondary

Measure	Time frame
CR Rate per central read for up to 15 years., DOR for up to 15 years., PFS for up to 15 years., Percentage of Participants Experiencing Treatment-Emergent Adverse Events for up to 15 years., Levels of anti-CD19 CAR T cells in blood at enrollment, Day 7, Week 2, Week 4, Month 3, Month 6, Month 12, Month 18, Month 24, annually up to year 5., Levels of cytokines in serum at enrollment, prior to axicabtagene ciloleucel infusion on Day 0, Day 3, Day 7, Week 2, Week 4., Percentage of Participants experiencing anti-axicabtagene ciloleucel antibodies at Week 4, Month 3, every 3 months up to Month 12., Percentage of Participants Experiencing clinically significant changes in lab values for up to 15 years, Time to next therapy for up to 15 years., Objective response rate among participants with 3 or more lines of prior therapy for up to 15 years., Complete response rate among those participants with 3 or more lines of prior therapy for up to 15 years., Objective Response Rate as Determined by th	—

Measure

Time frame

CR Rate per central read for up to 15 years., DOR for up to 15 years., PFS for up to 15 years., Percentage of Participants Experiencing Treatment-Emergent Adverse Events for up to 15 years., Levels of anti-CD19 CAR T cells in blood at enrollment, Day 7, Week 2, Week 4, Month 3, Month 6, Month 12, Month 18, Month 24, annually up to year 5., Levels of cytokines in serum at enrollment, prior to axicabtagene ciloleucel infusion on Day 0, Day 3, Day 7, Week 2, Week 4., Percentage of Participants experiencing anti-axicabtagene ciloleucel antibodies at Week 4, Month 3, every 3 months up to Month 12., Percentage of Participants Experiencing clinically significant changes in lab values for up to 15 years, Time to next therapy for up to 15 years., Objective response rate among participants with 3 or more lines of prior therapy for up to 15 years., Complete response rate among those participants with 3 or more lines of prior therapy for up to 15 years., Objective Response Rate as Determined by th

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Countries

France

Outcome results

None listed