Study of VIP152, Venetoclax, and Prednisone (VVIP) in Relapsed/Refractory Lymphoid Malignancies

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

April 5, 2023

Primary Completion Date

July 22, 2024

Study Completion Date

December 1, 2025

Conditions
LymphomaNon-Hodgkin LymphomaNHLHematologic MalignanciesLymphoid Malignancies
Interventions
DEVICE

Vysis LSI MYC Break Apart Rearrangement Probe Kit

MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.

DRUG

Venetoclax

"Dose Escalation: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity.~Dose Expansion: Administered orally, days 1-10, at the recommended phase 2 dose (RP2D); every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity"

DRUG

VIP152

"Dose Escalation: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity.~Dose Expansion: Administered intravenously, days 2 and 9, at the recommended phase 2 dose (RP2D); every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity."

DRUG

Prednisone

Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity

DIAGNOSTIC_TEST

PET

Screening, pre-cycle 7, pre-cycle 13, and at end-of-treatment (post-cycle 24).

DIAGNOSTIC_TEST

EKG

Screening

DIAGNOSTIC_TEST

ECHO

Screening

DIAGNOSTIC_TEST

CT neck chest, abdomen, and pelvis

Screening, pre-cycle 2, pre-cycle 3, pre-cycle 5, pre-cycle 7, pre-cycle 9, pre-cycle 11, pre-cycle 13, pre-cycle 15, pre-cycle 17, pre-cycle 19, pre-cycle 21, pre-cycle 23, and at end-of-treatment (post cycle 24).

DIAGNOSTIC_TEST

MRI

As indicated. Screening, pre-cycle 2, pre-cycle 3, pre-cycle 5, pre-cycle 7, pre-cycle 9, pre-cycle 11, pre-cycle 13, pre-cycle 15, pre-cycle 17, pre-cycle 19, pre-cycle 21, pre-cycle 23, and at end-of-treatment (post cycle 24).

PROCEDURE

Bone marrow aspiration/Biopsy

Baseline, post-cycle 6, post-cycle 12, and at end-of-treatment (post-cycle 24).

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH