| CTRI Number |
CTRI/2025/02/080943 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study that will help in determining the best antifungal in medicines that are used for preventing fungal infection in children receiving treatment for blood cancer |
|
Scientific Title of Study
|
Childhood Leukemia Antifungal Prophylaxis (CLAP) study: A Prospective, multi-arm multi stage randomized phase III, open label study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shyam Srinivasan |
| Designation |
Assistant Professor, Pediatric Medical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Pediatric Oncology, 1113, 11 floor, Homi Bhabha Block, Tata Memorial Hospital, Dr E Borges Road, Parel East.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
srinivas.shyam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam Srinivasan |
| Designation |
Assistant Professor, Pediatric Medical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Pediatric Oncology, 1113, 11 floor, Homi Bhabha Block, Tata Memorial Hospital, Dr E Borges Road, Parel East.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
srinivas.shyam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam Srinivasan |
| Designation |
Assistant Professor, Pediatric Medical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Pediatric Oncology, 1113, 11 floor, Homi Bhabha Block, Tata Memorial Hospital, Dr E Borges Road, Parel East.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
srinivas.shyam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre Research Administrative Council
Tata Memorial Hospital
3rd Floor, Main Building,
Dr. Ernest Borges Road. Parel.
Mumbai-400012, Maharashtra. India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr Ernest Borges Rd, Parel East, Parel, Mumbai, Maharashtra 400012. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raghawesh Ranjan |
Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital |
Pediatric oncology division
Homi Bhabha cancer hospital
Ground floor.opd number 1
Old loco colony,Shivpurwa
Ghanti mill road
Varanasi
UTTAR PRADESH |
9660417130
raghavranjan007@gmail.com |
| Dr Shyam Srinivasan |
Tata Memorial Hospital |
Dr E Borges Marg Parel East, 400012, Mumbai
Mumbai
MAHARASHTRA |
9619983999
srinivas.shyam@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C919||Lymphoid leukemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Micafungin |
Micafungin is used to treat fungal infections, including candidemia, acute disseminated candidiasis (fungal infection in the blood), candida peritonitis and abscess (fungal infection in the stomach), and esophageal candidiasis (fungal infection in the esophagus). Intravenous 3 mg/kg Twice a week. |
| Comparator Agent |
NA |
NA |
| Intervention |
Posaconazole |
Posaconazole is a triazole antifungal drug that is used to treat invasive infections by Candida species and Aspergillus species in severely immunocompromised patients. Oral suspension-6 mg/kg-Thrice daily. Oral tablets
6 mg/kg or 300mg (for 13 years and above) twice a day on day 1 followed by once a day daily |
| Intervention |
Voriconazole |
Voriconazole is used to treat serious fungal or yeast infections, such as aspergillosis (fungal infection in the lungs), candidemia (fungal infection in the blood), esophageal candidiasis (candida esophagitis), or other fungal infections (infections in the skin, stomach, kidney, bladder, or wounds). Oral-
9 mg/kg-Twice a day. Intravenous-9 mg/kg on day 1 followed by 8 mg/kg-Twice a day |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
High risk B-acute lymphoblastic leukemia
Intermediate risk B Cell Acute Lymphoblastic Leukemia.
B Cell lymphoblastic lymphoma.
T Cell Acute Lymphoblastic Leukemia
T Cell Lymphoblastic Lymphoma.
During induction phase of therapy.
Total bilirubin should be less than 1.5 x upper limit of normal for age.
SGOT or SGPT less than 5 x ULN for age |
|
| ExclusionCriteria |
| Details |
Standard risk Acute Lymphoblastic Leukemia
Patients with ALL for whom risk-group is unavailable.
Patients with a history of allergy to any of the study drugs.
A documented history of Invasive Fungal Infection within 30 days prior to randomization.
Patients on treatment for Invasive Fungal Infection.
Patients not consenting for the study. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the efficacy of various antifungal prophylaxis in preventing IFI in children with acute lymphoblastic leukemia during the induction and consolidation phases of therapy. |
Assessments will be done on at the start and end of the induction and consolidation phases of therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses mortality due to any cause. |
During the course of antifungal treatment. |
| To assess proven or probable IFI related invasive fungal infection related mortality. |
During the course of antifungal treatment. |
To assess the incidence of IFI, including invasive aspergillosis, candidiasis, mucor and any
other IFI. |
During the course of antifungal treatment. |
To assess prophylaxis failure. This would be defined as a development of proven or
probable IFI as defined above or the occurrence of an adverse event possibly or
probably related to the study treatment, resulting in discontinuation of treatment,
inability to deliver drug due to any reason for greater than 25% of the stipulated study duration or
receipt of any other systemic antifungal agent for 5 days or more for persistent fever or
suspected IFI |
During the course of antifungal treatment or post discontinuation. |
| Corelate voriconazole and posaconazole serum levels whenever available with drug doses and breakthrough IFI. |
During the course of antifungal treatment. |
|
|
Target Sample Size
|
Total Sample Size="720"
Sample Size from India="720"
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)
|
24/02/2025 |
| 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="3"
Months="0"
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 - NO
|
|
Brief Summary
|
The study discusses how invasive fungal infections (IFI) are increasingly affecting children with newly diagnosed acute lymphoblastic leukemia (ALL) and acute lymphoblastic lymphoma (LBL) who are undergoing intensive chemotherapy. According to a review of patient records at their center, about 23% of 420 patients developed some form of IFI, with 11.5% having confirmed or likely fungal infections. Most of these infections were caused by molds and typically occurred during the initial stages of treatment, especially in patients with T-cell ALL/LBL. The paragraph also discusses different antifungal medications like voriconazole, posaconazole, and micafungin, which are used to prevent these infections. It emphasizes the need for more research, like randomized controlled trials, to determine the best ways to prevent fungal infections, especially since different medications have varying levels of effectiveness in different regions and among different patient groups. |