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CTRI Number  CTRI/2025/03/083209 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 27/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Prevention of fungal infection in children with cancer 
Scientific Title of Study   Safety and efficacy of Fluconazole Plus Inhalational Liposomal Amphotericin B Versus Voriconazole for the Prevention of Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Leukemia: A Phase III open label Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naga Geetha Rani Mangam 
Designation  Senior resident 
Affiliation  AIIMS, Bhubaneswar 
Address  Room no 112, Hematology OPD, OPD block, department of Medical Oncology and Hematology, first floor, AIIMS, Bhubaneswar Post office - Sijua District - Khordha State - Odisha

Khordha
ORISSA
751019
India 
Phone  7093317573  
Fax    
Email  drgeetharani96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Debasish Sahoo 
Designation  Assistant Professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Room no 119, Hematology OPD, OPD block, department of Medical Oncology and Hematology, first floor, AIIMS, Bhubaneswar Post office - Sijua District - Khordha State - Odisha

Khordha
ORISSA
751019
India 
Phone  8872028232  
Fax    
Email  debasish0712@gmail.com  
 
Details of Contact Person
Public Query  
Name  Debasish Sahoo 
Designation  Assistant Professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Room no 119, Hematology OPD, OPD block, department of Medical Oncology and Hematology, first floor, AIIMS, Bhubaneswar Post office - Sijua District - Khordha State - Odisha


ORISSA
751019
India 
Phone  8872028232  
Fax    
Email  debasish0712@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Bhubaneswar, Bhubaneswar, PO Sijua, Dist: Khordha State: Odisha, India Pin: 759019 
 
Primary Sponsor  
Name  Naga Geetha Rani Mangam 
Address  Room no 112, Hematology OPD, OPD block, department of Medical Oncology and Hematology, first floor, AIIMS, Bhubaneswar Post office - Sijua District - Khordha State - Odisha Country: India Pin: 751019  
Type of Sponsor  Government medical college 
 
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 
Naga Geetha Rani Mangam  AIIMS, Bhubaneswar  Division of Pediatric Hematology oncology, Department of Medical Oncology/ Hematology, Room no 119 First floor, OPD block, AIIMS, Bhubaneswar Post office - Sijua District - Khordha State - Odisha India Pin: 751019
Khordha
ORISSA 		 7093317573

drgeetharani96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, Bhubaneswar  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], (2) ICD-10 Condition: C920||Acute myeloblastic leukemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral fluconazole plus inhalational amphotericin B  1. Oral fluconazole, 12 mg/kg/day, once a day 2. Inhalational Liposomal Amphotericin B, 25 mg per dose, once a day for 2 days per week 
Comparator Agent  Voriconazole  Oral voriconazole, 8 mg/kg/dose, twice a day  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Newly diagnosed children with high risk ALL, intermediate risk ALL, AML or relapsed ALL
2. Normal renal function
3. Normal liver function 
 
ExclusionCriteria 
Details  1. Patients with a diagnosis of APML, Down syndrome associated leukemia or JMML
2. Documented history of invasive fungal infection 3 months prior to enrollment
3. Patients already receiving treatment for invasive fungal infection
4. Hypersensitivity reaction documented for L amphotericin B or fluconazole or voriconazole
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of invasive fungal infections (proven, probable or possible)   3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Time to onset of fungal infection from chemotherapy initiation to the first episode of fungal infection  3 months 
Incidence, nature, and severity of adverse events (AEs) during the study  3 months 
Sensitivity, specificity, and predictive value of serum galactomannan for early detection of invasive fungal infections.  3 months 
Association of fungal infections with voriconazole trough levels  3 months 
 
Target Sample Size   Total Sample Size="236"
Sample Size from India="236" 
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 
Date of First Enrollment (India)   31/03/2025 
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="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drgeetharani96@gmail.com].

  6. For how long will this data be available start date provided 04-01-2027 and end date provided 04-01-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Invasive fungal infections (IFI’s) are the leading cause of morbidity and mortality among children undergoing chemotherapy, which is a substantial burden on healthcare systems. While antifungal prophylaxis offers reduction in the incidence of IFI’s, pediatric-specific data are essential to guide optimal treatment strategies. This is critical for children with acute leukemia, who represent the largest cohort at increased risk for IFI’s.

Primary Objective - To compare the efficacy of fluconazole plus inhalational liposomal amphotericin B versus voriconazole in preventing IFI in children undergoing chemotherapy for HR and IR ALL, AML, and relapsed ALL.

Secondary Objective(s) –

To evaluate the safety profiles of fluconazole plus inhalational liposomal amphotericin B and voriconazole

To compare the time to onset IFIs between the two-treatment group

To assess the yield of serial monitoring of serum galactomannan as a biomarker for early detection of IFIs in children undergoing chemotherapy

To evaluate the therapeutic drug monitoring (TDM) levels of voriconazole and to assess their correlation with safety, efficacy, and the prevention of IFIs.

Study Design - Phase III, Open-label, Randomized Controlled Trial (RCT)

 

Study Setting - This trial will be conducted at the Division of Pediatric Hematology and Oncology, Department of Medical Oncology/Hematology, at AIIMS Bhubaneswar.

Study Groups - <18 years of age diagnosed with ALL (HR and IR), AML, relapsed ALL

Sample size – A sample size of 118 is required in each group to detect a reduction by 11% in its incidence of fungal infection in fluconazole and inhalational L amphotericin B group. The incidence in voriconazole group is assumed as 16% (incidence of IFI in India as per Gouri et.al.,1 was 13% and as per COG western data was 19%). The alpha error and beta errors assumed are 0.05 and 0.2 respectively with a allocation ratio of 1:1

 Inclusion criteria –

Age: ≤ 18 years at the time of enrollment

Diagnosis Criteria:

  1. Newly diagnosed HR or IR B ALL and T ALL
  2. First or subsequent relapse of ALL
  3. Newly diagnosed AML

Organ Function Requirements:

Renal Function:

    1. Creatinine clearance ≥ 70 mL/min/1.73 m²

Liver Function:

    1. Total bilirubin ≤ 1.5 x ULN for age.
    2. SGOT or SGPT ≤ 2.5 x ULN for age.

 

Exclusion criteria 

7.      Patients with a diagnosis of APML, Down syndrome associated leukemia and JMML

8.      Documented history of IFI 3 months prior to enrollment 

9.      Patients already receiving treatment for IFI 

10.     Hypersensitivity reaction documented for L amphotericin B or fluconazole or voriconazole

 

Details of Control(s) – voriconazole arm

 Details of intervention – inhalational L amphotericin B and fluconazole arm

 Duration of study – 21 months (January 2025 till September 2026)


 
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