| 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
|
|
|
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
|
|
|
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. |