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Study in Adult Ph-positive ALL

NCT04688983 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2020-12-30

No results posted yet for this study

Summary

An Open Label, 3-arm, Randomised Phase II Study to Compare the Safety and Efficacy of Ponatinib in Combination With Either Chemotherapy or Blinatumomab With Imatinib Plus Chemotherapy as Front-line Therapy for Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL)

Conditions

  • Acute Lymphoblastic Leukemia, Adult

Interventions

DRUG

Ponatinib

30 mg QD starting day 1, given continuously unless interruption required for toxicity

DRUG

Blinatumomab

A single cycle of blinatumomab treatment is 6 weeks in duration, which includes 4 weeks of blinatumomab CIVI followed by a 2-week treatment-free interval.

DRUG

Imatinib

starting day 1, given orally at 400mg BID continuously for 8 weeks

Sponsors & Collaborators

  • Cardiff University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2024-01-31
Completion
2026-01-31

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Entities

Drugs

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 NCT04688983 on ClinicalTrials.gov