Comparison of two ways of using medications for preventing graft versus host disease after a half-matched stem cell transplant

A Phase II open-label, randomized controlled trial evaluating the effect of early versus conventional calcineurin inhibitor and mycophenolate mofetil initiation in graft-versus-host disease (GVHD) prophylaxis on the incidence of acute grade 2-4 GVHD in patients undergoing T cell replete haploidentical stem cell transplantation using post-transplant cyclophosphamide - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068451

Enrollment

120

Registered

2024-06-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C920- Acute myeloblastic leukemia

Interventions

Intervention1: Cyclosporine Mycophenolic acid mofetil: Cyclosporine 2.5mg/kg IV Q12H from day 0 Mycophenolic acid mofetil x 15mg per kg per dose x PO X TID with a maximum dose of 1g TID. Duration

Eligibility

Inclusion criteria

Inclusion criteria: Patients planned for haploidentical stem cell transplantation using post-transplant cyclophosphamide

Exclusion criteria

Exclusion criteria: 1. Patients planned for T cell depleted haplodentical stem cell transplantation 2. Patients with significant organ dysfunction (creatinine above 2mg%, liver enzymes above 5 times the upper limit of normal, LV ejection fraction less than 40%) 3. Patients with active infection at the time of transplant 4. Patients undergoing a second transplant

Design outcomes

Primary

Measure	Time frame
Acute grade 2-4 graft versus host disease by day 100 Acute GVHD will be graded as per the modified Glucksberg criteriaTimepoint: Day 100 assessment	—

Secondary

Measure	Time frame
Cytokine release syndrome CRS within 14 days post-stem cell infusion, Time to engraftment, Graft failure, Chronic GVHD, 1 year overall survival and plasma GVHD biomarkersTimepoint: Day 30 post transplant	—

Countries

India

Contacts

Public ContactUday Kulkarni

Christian Medical College Vellore, Ranipet Campus

kulkarni.uday@cmcvellore.ac.in04172224553

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026