Treatment of cancer with All trans Retinoic acid tablets.

Phase III open labelled randomized controlled study to evaluate the optimal dose of all-trans retinoic acid in the treatment of acute promyelocytic leukemia - Not applicable

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057990

Enrollment

280

Registered

2023-09-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs

Interventions

Intervention1: Arsenic trioxide All Trans Retinoic Acid (ATRA): Arsenic trioxide dose: 10mg x daily x 42 days ATRA: 45mg/m2 per day x 42 days Control Intervention1: Arsenic trioxide All Trans Retinoi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Willing to give a written informed consent. 2. Newly diagnosed APL by cytomorphology, confirmed by molecular analysis (PML::RARa fusion by RT-PCR or FISH or demonstration of t(15;17) by karyotyping). Age >15 years at screening 3.WHO performance status 0 - 3 (APPENDIX No. 8) 4. Serum total bilirubin 50% is indirect hyperbilirubinemia) Serum 5. creatinine 6. Women of child-bearing potential will be included only after negative pregnancy test unless they have undergone bilateral oophorectomy, tubal ligation or using a highly effective method of birth control (defined as those which result in a failure rate less than 1% per year) when used consistently and correctly such as implants, injectable, oral contraceptives, IUDs, sexual abstinence or vasectomized partner

Exclusion criteria

Exclusion criteria: 1. Other active malignancy at time of study entry 2. Uncontrolled cardiac arrhythmias, ECG abnormalities Cardiac dysfunction LVEF 4. Uncontrolled, life-threatening infections within the past 6-months or as per clinical judgment of the Investigator 5. Uncontrolled, life threatening intra-cranial hemorrhage within the past 6-months 6. Severe uncontrolled pulmonary disease 7. Grade 3 or more peripheral neuropathy 8. Women who are either pregnant or breast feeding 9. Concomitant severe psychiatric disorder which can interfere with treatment and compliance 10. HIV positive 11. No issues with active Hepatitis B or Hepatitis C infections 12. ECG abnormalities

Design outcomes

Primary

Measure	Time frame
To evaluate the net treatment benefit event free survival, documented infections, differentiation syndrome, hepatotoxicity / neuropathy in decreasing order between the two study armsTimepoint: 4 weeks	—

Secondary

Measure	Time frame
To compare the rates of post-induction complete hematological remission between the two study arms To compare the rates of complete molecular remission (bone marrow) post cycle 1 consolidation between the two study arms To compare the overall survival between the two study arms To compare rates of grade 3 or 4 toxicities between the two study armsTimepoint: 4 weeks	—

Countries

India

Contacts

Public ContactVikram Mathews

Christian Medical College Vellore Ranipet Campus

vikram@cmcvellore.ac.in9894903340

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026