Oral route supportive care measures during high dose methotrexate (drug) administration in children with blood cancer.

Not Applicable

• Conditions: Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]Health Condition 2: C859- Non-Hodgkin lymphoma, unspecifiedHealth Condition 3: C858- Other specified types of non-Hodgkin lymphoma

• Registration Number: CTRI/2022/02/040229
• Lead Sponsor: Dr Aditya Kumar Gupta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

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

Inclusion Criteria

Established diagnosis of hematolymphoid malignancy (acute lymphoblastic leukemia, Non-Hodgkin lymphoma) - primary or relapsed disease

On chemotherapy protocol requiring high dose methotrexate (HDMTX) (>=1g/m2/dose)

Eligible for HDMTX administration as per unit protocol and chemotherapy protocol

Atleast one previous course of HDMTX uneventfully administered with intravenous alkaline hydration.

Exclusion Criteria

Prior to start of HDMTX:

MTX toxicity during previous courses of HDMTX.

Requirement of intravenous hydration or intravenous alkalinization for any other reason (e.g. concurrent chemotherapy requiring intravenous hydration)

After the MTXT1:

Unsafe MTXT1

Clinical features of MTX toxicity

Nausea - Grade 3 and above

Vomiting - Grade 3 and above

Oral mucositis - Any grade

Fever - temperature > 100.4 F

Contraindication to enteral feeds e.g. ileus

Withdrawal criteria (after enrolment):

Failure to place NG tube due to patient denial or uncooperative child when IARTa is <40% or IARTb is <40% or IARTc is <85% or IARTd is <85%.

Unsafe MTXT2

Nausea - Grade 3 and above

Vomiting - Grade 3 and above

Oral mucositis - Any grade

Fever - temperature > 100.4 F

Contraindication to enteral feeds e.g. ileus, neutropenic enterocolitis

Requirement of more than 2 bolus doses of oral sodium bicarbonate to maintain target urine pH of 7.0 â?? 8.0

Urine output measured from time point p to time point c is <2ml/kg/hr.

Failed repeat oral dose of sodium bicarbonate or leucovorin 20 minutes after a vomited dose.

More than 2 episodes of vomited oral sodium bicarbonate or leucovorin

Study & Design

• Study Type: Interventional
• Study Design: Not specified