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CTRI Number  CTRI/2025/06/088638 [Registered on: 11/06/2025] Trial Registered Prospectively
Last Modified On: 29/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Preventive
Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study   Oral medication with valganciclovir as initial therapy for reactivation of low-risk cytomegalovirus following stem cell transplantation in children 
Scientific Title of Study   Open-label, prospective, multi-center, single-arm, academic clinical trial of oral Valganciclovir (VGCV) as pre-emptive therapy for ‘low-risk’ cytomegalovirus reactivation following alloHCT in children 
Trial Acronym  VALOR 
Secondary IDs if Any  
Secondary ID  Identifier 
SPK-2025-01, Version 1.0 dated 16-April-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohana Reddy 
Designation  Consultant Pediatric Hematology oncologist and Bone Marrow Transplant Physician  
Affiliation  Sankalp India Foundation 
Address  Sankalp Centre for Pediatric Hematology, Oncology and BMT, Bhagwan Mahaveer Jain Hospital (BMJH), 17 Millers Road, Kaverappa Layout, Vasanth Nagar, Bengaluru, Karnataka

Bangalore
KARNATAKA
560051
India 
Phone  8308833602  
Fax    
Email  dmmohanareddy@sankalpindia.net  
 
Details of Contact Person
Scientific Query
 
Name  Tejashree S 
Designation  Clinical Research Associate 
Affiliation  Sankalp India Foundation 
Address  Sankalp Centre for Pediatric Hematology, Oncology and BMT, Bhagwan Mahaveer Jain Hospital (BMJH), 17 Millers Road, Kaverappa Layout, Vasanth Nagar, Bengaluru, Karnataka

Bangalore
KARNATAKA
560051
India 
Phone  7338517742  
Fax    
Email  tejashree@sankalpindia.net  
 
Details of Contact Person
Public Query
 
Name  Rajat Kumar Agarwal 
Designation  President 
Affiliation  Sankalp India Foundation 
Address  Sankalp Centre for Pediatric Hematology, Oncology and BMT, Bhagwan Mahaveer Jain Hospital (BMJH), 17 Millers Road, Kaverappa Layout, Vasanth Nagar, Bengaluru, Karnataka

Bangalore
KARNATAKA
560051
India 
Phone  9880132850  
Fax    
Email  rajat@sankalpindia.net  
 
Source of Monetary or Material Support  
The trial is supported by DKMS and is being conducted at Sankalp-BMJH Centre for Pediatric Hematology Oncology and BMT- Bangalore and Sankalp-Health1 Centre for Pediatric Hematology Oncology and BMT- Ahmedabad  
 
Primary Sponsor  
Name  Sankalp India Foundation 
Address  Grace Mayur Building, 17, Millers Rd. Kaverappa Layout, Vasanth Nagar, Bengaluru, Karnataka 560051 
Type of Sponsor  Other [Non-Profit Organisation] 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepa Trivedi  Sankalp - Health1 Centre for Pediatric Hematology Oncology and BMT   5th Floor, Department of Pediatric Hematology, Oncology and BMT, Sankalp Centre, Near Venitian Villa, Shilaj Circle, Sardar Patel Ring Road, Thaltej, Ahmedabad – 380059
Ahmadabad
GUJARAT 
9924225911

deepahiren@sankalpindia.net 
Dr Mohana Reddy  Sankalp Centre for Pediatric Hematology, Oncology and BMT, Bhagwan Mahaveer Jain Hospital (BMJH)  7th Floor, Department of Pediatric Hematology, Oncology and BMT, Sankalp Centre, 17 Millers Road, Kaverappa Layout, Vasanth Nagar, Bengaluru, Karnataka 560051
Bangalore
KARNATAKA 
8308833602

dmmohanareddy@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Health 1 Institutional Ethics Committee  Approved 
Sankalp Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D618||Other specified aplastic anemias and other bone marrow failure syndromes, (2) ICD-10 Condition: D561||Beta thalassemia, (3) ICD-10 Condition: D57||Sickle-cell disorders, (4) ICD-10 Condition: B259||Cytomegaloviral disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Valganciclovir  Valganciclovir (VGCV) treatment will commence on the day of enrollment. The dose will be calculated as 7 × body surface area (BSA) × creatinine clearance (CrCl) (as per the modified Schwartz formula), administered twice daily, with a maximum of 900 mg per dose. The route of administration is oral. VGCV will be given for a minimum duration of 7 days. After 7 days, treatment will be stopped if two consecutive CMV PCR tests are negative or earlier if discontinuation is indicated as per predefined stopping rules due to inefficacy. The maximum duration of VGCV therapy in the trial is 6 weeks. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Signed written Informed Consent or Assent.
First CMV reactivation following alloHCT.
Less than 100 days elapsed since alloHCT.
Two CMV reports with greater than 1,000 copies per milliliter or 1 CMV report with
Greater than 10,000 copies per milliliter.
Males and females at an age between 3 and 18 years.
Minimum body weight of 10 kg.
Diagnosis of thalassemia, severe aplastic anemia, sickle cell disease
or Fanconi’s anemia.
For women of child bearing potential: a negative pregnancy test. 
 
ExclusionCriteria 
Details  Life-threatening CMV infection defined by:
DNAemia with greater than 100,000 copies per millilitre or
Clinically suspected CMV pneumonitis
Liver blood tests suggestive of CMV hepatitis such as Alanine aminotransferase greater than 3 times upper limit of norm and Aspartate aminotransferase or Alanine aminotransferase ratio less than 1 within one week prior to enrolment.
Watery diarrhea: greater than or equal to 3 stools per day and abdominal cramps as clinical signs
suggestive of CMV enterocolitis within 48 hours prior to enrolment.
Acute gut GVHD organ grade two to four.
Neutrophil count less than 500 million cells per liter
Patients with watery diarrhea greater than or equal to 3 stools per day and abdominal cramps, or bloody diarrhea for any reason within 48 hours prior to enrolment.
History of significant adverse reaction to GCV, VGCV, aciclovir or valacyclovir.
Clinically or molecularly proven GCV resistance.
Treatment with an investigational drug within the last 28 days.
Creatinine clearance less than 60 mL per minute per 1.73 meter square as calculated with the modified Schwartz formula.
Need for intensive care.
Inability to take oral drugs.
Simultaneous participation in another clinical trial.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint is confirmed clearance of CMV viremia (assessed by PCR) three weeks after start of VGCV treatment.   3 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
The following secondary endpoints will be addressed in all populations: Rate of neutropenia & thrombocytopenia, VGCV pharmacokinetics, CMV clearance & rate of recurrent CMV reactivation.  Efficacy of oral valganciclovir will be tested on day 5 or 6 after administration of medication. Rate of neutropenia at week 3. Thrombocytopenia will be checked at week 3. Rate of CMV recurrence at week 12 after trial start for each subject. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   01/07/2025 
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 Applicable 
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  

Intravenous ganciclovir GCV, currently the recommended standard treatment for cytomegalovirus CMV disease in transplant recipients in India, requires hospitalization, often a central intravenous line, and thus is expensive and inconvenient for patients. A safe and effective oral therapy may significantly improve and simplify the management of posttransplant CMV disease. Oral VGCV showed comparable safety and was not inferior to intravenous GCV for treatment of CMV disease in organ transplant recipients and provided a simpler treatment strategy in a randomized, open-label, parallel-group, active drug-controlled, multi-center noninferiority trial at 42 centers including 326 patients. Adult solid organ transplant recipients with both virologic and clinical evidence of CMV disease, regardless of donor or recipient CMV serostatus were enrolled into this trial. Baseline viral loads were not different between groups. Side-effects and discontinuations of assigned treatment were comparable. The success rate at day 21 defined as a negative plasma polymerase chain reaction PCR, Roche Diagnostics, USA with a cut-off of 600 copies per mL for CMV was 45.1 percentage for VGCV and 48.4 percentage for GCV. Winston et al. studied the pharmacokinetics of VGCV and GCV in a cross-over design in adult patients after allogeneic stem cell transplantation with Graft-versus-Host Disease GVHD of the gastrointestinal tract and established noninferiority of VGCV. Data on pediatric patients after allogeneic HCT alloHCT are available from a phase II trial in which all patients first received GCV but some patients later on switched to the oral drug. Both treatments were equally effective. VGCV is not approved by European Medicines Agency EMA or U.S. Food and Drug Administration FDA for the pre-emptive treatment of CMV reactivations in pediatric patients following alloHCT but still is common practice in many experienced centers. Therefore, this trial aims at demonstrating safety and efficacy of VGCV for the pre-emptive treatment of pediatric patients with CMV reactivation after alloHCT.

 
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