This is a comparative study of Azacitidine 300 mg tablet in Adult Patients with Acute Myeloid Leukemia (Blood Cancer).

Not yet recruiting

• Conditions: Myeloid leukemia, unspecified,

• Registration Number: CTRI/2025/04/084864
• Lead Sponsor: Hikma Pharmaceuticals

Brief Summary

This is randomized, two treatment, four period, full replicate, crossover, bioequivalence study between test and reference product in patients diagnosed with acute myeloid leukaemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy will be enrolled after getting written informed consent.

All eligible patients will be randomly assigned to receive a single dose of 300 mg Azacitidine of either test product (two doses, one dose in each period) or the reference product (two doses, one dose in each period) with 240 ml of water after atleast 10 hours of overnight fasting on each night using IWRS . Patients will be randomized into two treatment sequence groups, sequence 1 (TRTR) and sequence 2 (RTRT), where T represents the test product and R represents the reference product).

The study consists of a screening period of 14 days and 4 treatment periods of 1 day each, of the same treatment cycle (Period I [Day 1], Period II [Day 2], Period III [Day 3] and Period IV [Day 4]).

Total duration of study will be 32 days (Approximately) for each patient  consists of a screening period of 14 days prior to first study drug administration wherein:

Check in on Day -1

Study drug administration on Day 1 (period-I), Day 2 (period-II), Day 3 (period-III) and Day 4 (Period-IV).

Discharge on Day 4 after completion of study activities.

Follow-up by the PI or designee by phone call within 7 to 14 days after the last Azacitidine drug administration.

Total 56 PK Samples will be collected on Day 1 to Day 4 of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-28
• Last Update Posted: 2025-11-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patients with documented diagnosis of AML according to the 2022 updates of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukaemia.
• Patients with AML who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy.
• The definitions of response criteria for CR or CRi are primarily those defined by the 2022 report from the European Leukemia Net (ELN) on AML as below: CR defined as bone marrow blasts less than 5%; absence of circulating blasts; absence of extramedullary disease; ANC equal to or more than 1.0 × 10^9/L (1,000/µL); platelet count equal to or more than 100 × 10^9/L (100 000/µL).
• CRi defined as all CR criteria, except for residual, neutropenia less than 1.0 × 10^9/L (1,000/µL) or thrombocytopenia less than 100 × 10^9/L (100 000/µL).
• Patients who don’t have a known or suspected hypersensitivity to Azacitidine or any other ingredient used in the manufacturing of Azacitidine.
• Patients who are physically able for appropriate pharmacokinetics sampling according to principal investigator evaluation.
• Patients who have a haematological profile appropriate for receiving Azacitidine 300 mg dose for 4 consecutive days as per the principal investigator assessment.
• Patients who understand and voluntarily sign a written informed consent document prior to any study related assessments/procedures are conducted.
• Patient is capable of consent.
• Females of childbearing potential may participate, providing the subject meets the following conditions: Negative serum pregnancy test at screening, and willing to use effective contraception during and up to 6 months after study.
• Male patients must be willing to use effective contraception during and up to 3 months after the study.

Exclusion Criteria

• Patients with history of drug or alcohol abuse 2.
• Female patients who are pregnant or lactating.
• Patients with medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition of the study.
• Patients with positive blood screen for HIV, Hepatitis B (HbsAG) or Hepatitis C (HCV) virus.
• Patients with experience in any investigational drug in a clinical study within 6 months prior to study Day 1.
• Patients has a difficulty fasting, consuming standard meals or history of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption.
• Patients does not agree to not be engaged in strenuous exercise at least one day prior to study drug administration until donating the last sample of the study.
• Patients does not agree to not consuming any beverages or food containing grapefruit for at least two weeks prior to first study drug administration until donating the last sample of the study.
• Patients does not agree to not consuming any beverages or food containing methyl-xanthines e.g., caffeine (coffee, tea, cola, energy drinks, chocolate etc.) and alcohol containing beverages at least 48 hours prior to first study drug administration until donating the last sample of the study.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the bioequivalence of the Test Product (Azacitidine 300 mg Film coated tablets (300 mg Azacitidine) manufactured for Hikma Pharmaceuticals (MAH)) relative to Reference Product (Onureg 300 mg Film Coated Tablets (300 mg Azacitidine) manufactured by Celgene Corporation after a single oral dose administration in adult patients with AML under fasting conditions.	On each period 14 blood samples will be collected, 1 predose sample at 0.00 hr and 13 post dose sample at 0.167 (10 mins), 0.333 (20 mins), 0.50 (30 mins), 0.75 (45 mins) ,1.00, 1.25, 1.50, 1.75, 2.00 ,2.50, 3.00, 4.00 and 5.00 hours.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability	1. Adverse Events (AEs) [Time Frame: Up to Day 4 at discharge].

Trial Locations

Locations (10)

Asian Kidney Hospital and Medical Centre; 🇮🇳 Nagpur, MAHARASHTRA, India

Bhartiya Vidyapith Medical college Hosptial & Research Center; 🇮🇳 Pune, MAHARASHTRA, India

Dr Bafnas Star Superspeciality Clinic and Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

Hande Hospital; 🇮🇳 Chennai, TAMIL NADU, India

HCG Cancer Centre; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Health Point Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Horizon Multispeciality Hospital; 🇮🇳 Sangli, MAHARASHTRA, India

Ishwar Institute of Health Care; 🇮🇳 Aurangabad, MAHARASHTRA, India

Nano Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

PP Maniya Hospital PVT LTD; 🇮🇳 Surat, GUJARAT, India

Asian Kidney Hospital and Medical Centre

🇮🇳Nagpur, MAHARASHTRA, India

Dr Shriram Kane

Principal investigator

9823012851

shriramkane@gmail.com