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Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia

NCT06982274 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-05-30

No results posted yet for this study

Summary

It is a non-randomized, multicenter, prospective study, aiming to treat patients with newly diagnosed acute promyelocytic leukemia with a combination of oral arsenic and atra, with low dose chemotherapy for those with high-risk disease (white blood cell count above 10x10a9/L). The primary objective is to assess the 2-year overall survival (OS) in these patients, comparing with the historical control group of patients treated with ATRA/chemotherapy according to the IC-APL 2006 protocol.

Conditions

  • Acute Promyelocytic Leukemia (APL)

Interventions

DRUG

Realgar-Indigo Naturalis Formulation

Oral Arsenic (Realgar-Indigo Naturalis Formulation) plus ATRA for low-intermediate risk APL pts, combined with daunorubicin for high-risk during induction

Sponsors & Collaborators

Principal Investigators

  • Eduardo M Rego, MD PhD · Instituto do Cancer do Estado de Sao Paulo

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
2023-10-20
Primary Completion
2028-11-30
Completion
2029-11-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

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 NCT06982274 on ClinicalTrials.gov