West Cancer Center

LYMPHOMA: B-cell NHL or DLBCL; "GO27878"

A phase Ib/II open-label study evaluating the safety and pharmacokinetics of GDC-0199 (ABT-199) in combination with rituximab (R) or obinutuzumab (G) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with B-cell non-Hodgkin's lymphoma (NHL) and DLBCL

Title

Hoffman-La Roche GO27878

Study Title

Site Link

NCT02055820

Malignancy

Lymphoma, Diffuse Large B-cell Lymphoma, Non-Hodgkin's lymphoma, DLBCL, NHL, Follicular lymphoma (FL)

Stage

N/A

Disease Setting

Untreated

Line Of Therapy

1st

Investigational Agent

GDC-0199 (ABT-199)

Drug Class

Inhibitor of Bcl-2 (pro-apoptotic agent)

Jason Chandler, MD

Sponsor

Hoffman-La Roche

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

NCT02055820

Key Eligibility Criteria Details

Age >18

ECOG PS 0-2

At least 1 bidimentionally measurable lesion defined as 1.5 cm in longest diamter

No prior R-CHOP therapy

Dose expansion portion: No prior systemic therapy (1st line)

Dose expansion portion: IPI 2-5

No transformed lymphoma or primary CNS lymphoma

No prior radiotherapy to mediastinal/pericardial region

No concommitant use of warfarin

Objective

Primary- DLTs, CR rate by PET/CT and BMBx; Secondary- Relative dose intensity, ORR, DoR, PFS, OS, PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

B-cell origin lymphoma

Dosing Frequency

Control Agents

CHOP with either Rituxan or Obinituzumab

Study Protocol

Randomized