Extended dosing of aprepitant to decrease vomiting and nausea that occurs late during chemotherapy for acute myeloid leukaemia

Phase 3

• Conditions: Health Condition 1: C920- Acute myeloblastic leukemia

• Registration Number: CTRI/2023/03/050220
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients with confirmed diagnosis of acute myeloid leukaemia

Age more than or equal to 18 years, with weight more than or equal to 30 kg

Chemo-naïve

Scheduled to receive first cycle of AML induction chemotherapy 3 days of daunorubicin at 60 mg/m2 and 7 days of cytosine arabinoside infusion @ 100 mg/m2 24-hour infusion.

Patient or their attendants can understand Hindi /Tamil/English, and are willing for participation in the study and for follow-up

Exclusion Criteria

Vomiting, retching, or more than mild nausea within 24 hours before the start of chemotherapy

Any history of CNS disease including brain metastasis, seizure disorder or psychosis.

Significant organ dysfunction SGOT or SGPT more than 2.5 times ULN, S. bilirubin more than 1.5 times ULN, S. creatinine more than 1.5times ULN

Not willing to participate in the study.

Need for contraindicated concomitant medication (pimozide, terfenadine, astemizole, or cisapride)

Need for medication that strongly induces CYP3A4 activity (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital)

Patients on systemic steroids other than for use as an antiemetic agent

Prior aprepitant or fosaprepitant use.

Received radiotherapy to abdomen, pelvis, cranium, or craniospinal regions, in the week prior to treatment initiation

Study & Design

• Study Type: Interventional
• Study Design: Not specified