Treatment of cancer with All trans Retinoic acid tablets.

Phase 3

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

Registration Number: CTRI/2023/09/057990

Lead Sponsor: Haematology Cancer Consortium

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 = 3.0 mg/dL (except if >50% is indirect hyperbilirubinemia) Serum 5. creatinine = 2.0 mg/dL (unless due to differentiation syndrome)

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

1. Other active malignancy at time of study entry

2. Uncontrolled cardiac arrhythmias, ECG abnormalities Cardiac dysfunction LVEF <50%

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To compare the rates of post-induction complete hematological remission between the two study arms <br/ ><br>To compare the rates of complete molecular remission (bone marrow) post cycle 1 consolidation between the two study arms <br/ ><br>To compare the overall survival between the two study arms <br/ ><br>To compare rates of grade 3 or 4 toxicities between the two study armsTimepoint: 4 weeks