West Cancer Center

LYMPHOMA: NHL; Follicular and DLBCL; "GO29365"

A Phase Ib/II study evaluating the safety, tolerability, and anti-tumor activity of polatuzumab vedotin (DCDS4501A) in combination with rituximab (R) or obinutuzumab (G) and bendamustine (B) in relapsed or refractory follicular or diffuse large B-cell lymphoma

Title

Hoffman-La Roche GO29365

Study Title

Site Link

NCT02257567

Malignancy

Lymphoma, NHL, Non-hodgkin lymphoma, DLBCL, FL, follicular, diffuse large B-cell

Stage

Disease Setting

Relapsed/Refractory

Line Of Therapy

>2nd line

Investigational Agent

Polatuzumab Vedotin

Drug Class

Antibody-drug conjugate to CD79b

Daruka Mahadevan, MD, PhD

Sponsor

Hoffman-La Roche

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/NCT02257567

Key Eligibility Criteria Details

Relapsed/refractory Follilular or DLBCL
If prior bendamustine, duration must have been >12 months
Availability of archived tissue
At least 1 measurable lesion (>/= 1.5cm in longest dimension)
No allo-HCT, no auto HCT within 3 months
No grade 3b Follicular lymphoma
No Grade >1 peripheral neuropathy
No known HIV, HBV, HCV

Objective

Primary- DLT, CRR; Secondary- AEs, Event-free survival, DOR, PFS, PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Follicular: Grade 1-3aDLBCL: Any grade

Dosing Frequency

Polatuzumab- IV on C1D2, then day 1 up to 6 cycles

Control Agents

Bendamustine 90mg IV, Obinutuzumab 1000mg IV

Study Protocol

Randomized