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CTRI Number  CTRI/2025/01/078974 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 19/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of olanzapine in precursor lymphoid neoplasm during induction chemotherapy  
Scientific Title of Study   Efficacy of olanzapine in comparison with placebo in treatment of anorexia in children aged 7 to 15 years with precursor lymphoid neoplasm during induction chemotherapy: A double blinded randomised controlled pilot study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Susmitha paul 
Designation  Junior resident  
Affiliation  Jawaharlal Institute of Post graduate Medical Education And research, JIPMER 
Address  Department of Paediatrics, 2nd floor, Women and Child block, JIPMER, Dhanvantari Nagar, Puducherry- 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  8240043438  
Fax    
Email  susmithapaulpta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jaikumar GR 
Designation  Associate professor  
Affiliation  Jawaharlal Institute of Post graduate Medical Education And Research, JIPMER 
Address  Department of Paediatrics, 2nd floor, Women and Child Hospital, JIPMER, Dhanvantari Nagar, Puducherry- 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  8196800157  
Fax    
Email  gr_jaikumar@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Jaikumar G R 
Designation  Associate professor  
Affiliation  Jawaharlal Institute of Post graduate Medical Education And Research JIPMER 
Address  Department of Paediatrics, 2nd floor, Women and Child Hospital, JIPMER, Dhanvantari Nagar, Puducherry- 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  8196800157  
Fax    
Email  gr_jaikumar@yahoo.in  
 
Source of Monetary or Material Support  
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, DHANAVANTRI NAGAR, PUDUCHERRY PIN:- 600506 INDIA 
 
Primary Sponsor  
Name  Not applicable  
Address  Not applicable  
Type of Sponsor  Other [Not applicable ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Susmitha paul  JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH   Pediatrics ward no 466, PEDIATRICS ward no 270 and PEDIATRICS casualty no 127, Department of pediatrics, Women and child block, Dhanvantari nagar, Puducherry
Pondicherry
PONDICHERRY 		 8240043438

susmithapaulpta@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER Institutional Ethics committee - interventional studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL],  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Olanzapine   Children aged 7 to 15 years with precursor lymphoid neoplasm on induction therapy will receive their chemotherapeutic drugs along with olanzapine. Olanzapine will be given daily for period of 35 days of induction therapy. Each capsule containing Olanzapine of strength 2.5 mg is being used. It will be given according to body weight at the time of admission and the maximum dose will be 2.5 mg/day. Maximum of one capsule will be used per day.  
Comparator Agent  Placebo   Children aged 7 to 15 years with precursor lymphoid neoplasm on induction therapy will receive chemotherapeutic drugs and placebo. Placebo which will of same size, shape and colour of that of olanzapine will be given daily for period of 35 days of induction therapy. Placebo will also be in capsule formulation. Maximum of one capsule will be given per day.  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  All children aged 7 years to 15 years with precursor lymphoid neoplasm receiving induction chemotherapy who are admitted in wards/ ER of department of pediatrics, JIPMER  
 
ExclusionCriteria 
Details  Children refusing therapy/referred or discharged to other institute  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the difference in mean change in weight recorded on day 1 and day 35 of induction in children randomized to olanzapine and placebo arm aged 7 to 15 years with precursor lymphoid neoplasm  Day 1 to day 35 of induction therapy  
 
Secondary Outcome  
Outcome  TimePoints 
To study the efficacy of olanzapine in comparison to placebo in improving anorexia as measured by peds FAACT score on day 7 of induction chemotherapy in children aged 7 to 15 years with precursor lymphoid neoplasm

To study the efficacy of olanzapine in comparison to the placebo in improving anorexia as measured by peds FAACT score on day 35 of induction chemotherapy in children aged 7 to 15 years with precursor lymphoid neoplasm  		 Day 1 to day 35 of induction therapy  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study will be conducted in department of pediatrics, JIPMER, Puducherry. Permission will be obtained from JIPMER Postgraduate research monitoring committee (PGRMC) and the institute of ethics committee (IEC) and CTRI registration prior to enrollment of first patient to conduct the study. This study shall include children of age 7 to 15 years with precursor lymphoid neoplasm on induction chemotherapy. All consecutive children with precursor lymphoid neoplasm receiving induction chemotherapy will be included during study period of January 2025 to December 2026. Written informed consent will be taken from the parents/LAR of the study participants and verbal assent from participants aged 7 to 12 years and written assent from children older than 12 years. Stratified block randomisation with block size of 6 will be done. Stratification will be based on whether patient is treated as standard or non standard risk of treatment protocol. Control and intervention group will be labelled as either group 1 or group 2. Control group will receive chemotherapy drug and placebo. Intervention group will receive chemotherapy drug and olanzapine. Randomisation will be done by computer generated random sequence and allocation concealment will be done by SNOSE technique. Once patient gets enrolled, evaluation of nutritional status and anorexia will be done. Parameter for nutritional status assessment will be weight, height, tsft. Anorexia will be assessed using pediatrics FAACT score V.2. Dietary information will be obtained on day 7 and day 34 of induction chemotherapy. The dose of olanzapine or placebo will be calculated based on weight at the time of enrollment and maximum dose will be capped at 2.5 mg per day. All participants will receive chemotherapeutic drugs. They will receive placebo or olanzapine based on randomisation. They will be followed up for 35 days during induction chemotherapy. They will be observed for treatment response and adverse effects like drowsiness, dystonia, urinary retention if any. Pediatrics FAACT score v.2 will be used at the end of 7 and 35 days of induction chemotherapy. Weight will be measured daily. Height and TSFT will bed done at day 35 of induction chemotherapy. Modified intention to treat as well as per protocol analysis will be performed. 
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