NCT06982274

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for phase_2

Timeline
42mo left

Started Oct 2023

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Oct 2023Nov 2029

Study Start

First participant enrolled

October 20, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

May 13, 2025

Last Update Submit

May 26, 2025

Conditions

Acute Promyelocytic Leukemia (APL)

Keywords

Acute promyelocytic leukemiaOral arsenicSurvivalAll trans-retinoic acid

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    This endpoint includes death from any cause, including early death, death due to disease progression, or any death occurring after achieving complete remission.

    2 years

Secondary Outcomes (8)

  • Complete hematologic response rate after induction.

    30 days

  • Early death rate during induction

    30 days

  • Disease-free survival rate

    2 years

  • Cumulative incidence of myelodysplasia and secondary leukemia

    5 years

  • Cumulative incidence of relapse

    2 years

  • +3 more secondary outcomes

Study Arms (1)

Proposed protocol

EXPERIMENTAL

Oral Arsenic + ATRA with low-dose daunorubicin for high-risk patients

Drug: Realgar-Indigo Naturalis Formulation

Interventions

Realgar-Indigo Naturalis FormulationDRUG

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

Also known as: Oral Arsenic
Proposed protocol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • New diagnosis of APL by cytomorphology, confirmed for molecular analysis
  • Age ≥18 and ≤75 years
  • Serum total bilirubin ≤ 3.0 mg/dl (≤ 51 μmol/l)
  • Serum creatinine ≤ 3.0 mg/dl (≤ 260 μmol/l)

You may not qualify if:

  • High-risk patients who are not eligible for chemotherapy according to the judgment of the treating physician;
  • Age \<18 or \>75 years
  • Other active malignancy at the time of study entry
  • Lack of diagnostic confirmation at the genetic level
  • Significant arrhythmias, ECG abnormalities, or neuropathy: Congenital long QT syndrome; History or presence of significant ventricular or atrial tachyarrhythmia; Clinically significant resting bradycardia (\<50 beats per minute); QTc \> 500 ms on ECG screening for both sexes; Right bundle branch block with left anterior hemiblock or bifascicular block
  • High-risk patients with other cardiac contraindications for intensive chemotherapy (LVEF \< 50%)
  • Uncontrolled and potentially fatal infections
  • Severe uncontrolled pulmonary or cardiac disease
  • Severe hepatic or renal dysfunction
  • Known HIV and/or hepatitis C infection
  • Pregnant or breastfeeding women
  • Allergy to the study drug or excipients in the study medication
  • Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or the assessment of study outcomes
  • Use of other investigational drugs at the time of enrollment or within 30 days before study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, 01246000, Brazil

RECRUITING

Related Publications (4)

  • Silva WF, Kim HT, Undurraga MS, Navarro-Cabrera JR, Salinas V, Muxi P, Melo RAM, Gloria ABF, Pagnano KBB, Nunes EC, Bittencourt RI, Rojas N, Truyenque SMQ, Ayala-Lugo AI, Oliver AC, Figueiredo-Pontes LL, Traina F, Moreira F, Fagundes EM, Duarte BKL, Mora-Alferez AP, Ortiz P, Untama JL, Tallman MS, Ribeiro RC, Ganser A, Dillon RJ, Valk PJM, Sanz MA, Lowenberg B, Berliner N, Rego EM. Early death and intracranial hemorrhage prediction in acute promyelocytic leukemia: validation of a risk score in a cohort from an international consortium treated with chemotherapy plus all-trans retinoic acid. Haematologica. 2025 Mar 1;110(3):795-798. doi: 10.3324/haematol.2024.286338. No abstract available.

    PMID: 39479861BACKGROUND

  • Koury LCA, Kim HT, Undurraga MS, Navarro-Cabrera JR, Salinas V, Muxi P, Melo RAM, Gloria AB, Pagnano K, Nunes EC, Bittencourt RI, Rojas N, Quintana S, Ayala-Lugo A, Oliver AC, Figueiredo-Pontes L, Traina F, Moreira F, Fagundes EM, Duarte BKL, Mora-Alferez AP, Ortiz P, Untama J, Tallman M, Ribeiro R, Ganser A, Dillon R, Valk PJM, Sanz M, Lowenberg B, Berliner N, Rego EM. Clinical networking results in continuous improvement of the outcome of patients with acute promyelocytic leukemia. Blood. 2024 Sep 19;144(12):1257-1270. doi: 10.1182/blood.2024023890.

    PMID: 38805638BACKGROUND

  • Correa de Araujo Koury L, Ganser A, Berliner N, Rego EM. Treating acute promyelocytic leukaemia in Latin America: lessons from the International Consortium on Acute Leukaemia experience. Br J Haematol. 2017 Jun;177(6):979-983. doi: 10.1111/bjh.14589. Epub 2017 May 3.

    PMID: 28466545BACKGROUND

  • Rego EM, Kim HT, Ruiz-Arguelles GJ, Undurraga MS, Uriarte Mdel R, Jacomo RH, Gutierrez-Aguirre H, Melo RA, Bittencourt R, Pasquini R, Pagnano K, Fagundes EM, Chauffaille Mde L, Chiattone CS, Martinez L, Meillon LA, Gomez-Almaguer D, Kwaan HC, Garces-Eisele J, Gallagher R, Niemeyer CM, Schrier SL, Tallman M, Grimwade D, Ganser A, Berliner N, Ribeiro RC, Lo-Coco F, Lowenberg B, Sanz MA. Improving acute promyelocytic leukemia (APL) outcome in developing countries through networking, results of the International Consortium on APL. Blood. 2013 Mar 14;121(11):1935-43. doi: 10.1182/blood-2012-08-449918. Epub 2013 Jan 14.

    PMID: 23319575BACKGROUND

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Interventions

Arsenic

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, AcuteLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

MetalloidsElementsInorganic Chemicals

Study Officials

  • Eduardo M Rego, MD PhD

    Instituto do Cancer do Estado de Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaine Uehara

CONTACT

55 38933535elaine.uuehara@hc.fm.usp.br

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 21, 2025

Study Start

October 20, 2023

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2029

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)