A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel in Adults with Rare B-cell Malignancies (ZUMA-25) – Substudy A – Relapsed/Refractory Waldenstrom Macroglobulinemia

Conditions

Relapsed/Refractory Waldenstrom Macroglobulinemia (WM)

Brief summary

The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy A (WM) is combined rate of CR and VGPR rate by central assessment defined as the proportion of subjects who achieve either CR or VGPR .

Detailed description

The secondary endpoints of ZUMA-25 as per the master protocol are: • CR rate by central assessment as defined in each substudy, • Duration of Response, • Overall Survival, • Progression-free survival, • Time to next treatment defined as the time from enrollment (for Full Analysis Set [FAS]) or brexucabtagene autoleucel infusion (for modified intention to treat [mITT]) to the initiation of subsequent anticancer therapy/treatment, • Time to first response from brexucabtagene autoleucel infusion to the first response as defined in the substudy, Substudy A (WM) specific secondary endpoints are: •ORR, defined as the proportion of subjects who achieve a best response of CR, VGPR, or partial response (PR), • Combined CR and VGPR rate by investigator assessment defined as the proportion of subjects who achieve either CR or VGPR, • Rate of VGPR and PR, separately

Related papers

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Interventions

DRUGMESNA

DRUGTecartus 0.4 – 2 × 108 cells dispersion for infusion

DRUGIMBRUVICA 140 mg hard capsules

DRUGCYCLOPHOSPHAMIDE

DRUG-

DRUGMETHYLPREDNISOLONE

DRUGDEXAMETHASONE

DRUGFLUDARABINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy A (WM) is combined rate of CR and VGPR rate by central assessment defined as the proportion of subjects who achieve either CR or VGPR .	—

Secondary

Measure	Time frame
The secondary endpoints of ZUMA-25 as per the master protocol are: • CR rate by central assessment as defined in each substudy, • Duration of Response, • Overall Survival, • Progression-free survival, • Time to next treatment defined as the time from enrollment (for Full Analysis Set [FAS]) or brexucabtagene autoleucel infusion (for modified intention to treat [mITT]) to the initiation of subsequent anticancer therapy/treatment, • Time to first response from brexucabtagene autoleucel infusion to the first response as defined in the substudy, Substudy A (WM) specific secondary endpoints are: •ORR, defined as the proportion of subjects who achieve a best response of CR, VGPR, or partial response (PR), • Combined CR and VGPR rate by investigator assessment defined as the proportion of subjects who achieve either CR or VGPR, • Rate of VGPR and PR, separately	—

Measure

Time frame

The secondary endpoints of ZUMA-25 as per the master protocol are: • CR rate by central assessment as defined in each substudy, • Duration of Response, • Overall Survival, • Progression-free survival, • Time to next treatment defined as the time from enrollment (for Full Analysis Set [FAS]) or brexucabtagene autoleucel infusion (for modified intention to treat [mITT]) to the initiation of subsequent anticancer therapy/treatment, • Time to first response from brexucabtagene autoleucel infusion to the first response as defined in the substudy, Substudy A (WM) specific secondary endpoints are: •ORR, defined as the proportion of subjects who achieve a best response of CR, VGPR, or partial response (PR), • Combined CR and VGPR rate by investigator assessment defined as the proportion of subjects who achieve either CR or VGPR, • Rate of VGPR and PR, separately

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Countries

Austria, France, Germany, Italy, Netherlands, Spain, Sweden

Outcome results

None listed