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Platform Study for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma (PRISM Study)

NCT03527147 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-08-15

No results posted yet for this study

Summary

This is a Phase 1 platform protocol designed to evaluate various targeted agents for the treatment of relapsed/refractory aggressive Non-Hodgkin's Lymphoma (NHL).

Conditions

Interventions

DRUG

AZD9150

AZD9150 will be administered as a 1-hour intravenous (IV) infusion on Days 1, 3, 5 of Cycle 1, followed by weekly infusions (starting Day 8 of Cycle 1 and beyond).

DRUG

Acalabrutinib

Acalabrutinib will be administered orally twice daily (bid).

DRUG

AZD6738

AZD6738 will be administered orally twice daily (bid).

DRUG

Hu5F9-G4

HU5F9-G4 infusions will be given on Weekly (Day 1, 8, 15, and 22) during the first two 28-day cycles, then will be given every two weeks (Day 1 and Day 15) in Cycle 3 and beyond.

DRUG

Rituximab

Rituximab infusions will be given Weekly starting on Day 8 (Day 8, 15, and 22) during the first 28-day cycle (4 weeks), then Day 1 of each 4 week cycle for Cycles 2-6. Starting with Cycle 8, Rituximab will be infused on Day 1 of every other cycle (every 8 weeks).

DRUG

AZD5153

AZD5153 will be administered orally once per day (qd).

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Acerta Pharma BV

    lead INDUSTRY

Principal Investigators

  • Ian Flinn, MD, PhD · Tennessee Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03527147 on ClinicalTrials.gov