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Mutant p53-based Personalized Trial Using Decitabine and Arsenic Trioxide on AML/MDS

NCT03855371 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-11-04

No results posted yet for this study

Summary

TP53 mutation is commonly associated with poor cancer patient prognosis yet no mutant p53 (mp53)-targeting regimen was clinically established. Here the investigators try to evaluate the side effect and treatment potential of DAC+ATO in p53 mutated high-risk AML/MDS patients.

About 200 AML/MDS patients will be sequenced for TP53 sequence before recruitment. The investigators estimated about 5 patients, based on the reported p53 mutation frequency in AML/MDS, will be p53-mutated. In the trial, the investigators will selectively recruit the mp53 AML/MDS patients that are predicted to respond to DAC+ATO regimen with highest chance (based on the relevant basic studies).

The investigators designate mutant p53-based clinical trials as 'PANDA (P53 AND Arsenic)-Trials'.

Conditions

  • P53 Mutation
  • Myeloid Malignancy
  • MDS
  • Aml

Interventions

DRUG

Decitabine

20mg/m2/d, intravenously, d1-d5, q4w

DRUG

Arsenic Trioxide

0.16mg/kg/d, intravenously, d1-d5, q4w(maximum dose: 10mg/d)

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Sujiang Zhang, MD, PhD · Shanghai Institute of Hematology, Ruijin Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2023-07-31
Completion
2024-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03855371 on ClinicalTrials.gov