Thalassemia study with stem cells

Post-transplant cyclophosphamide as GVHD prophylaxis in high risk Thalassemia undergoing allogeneic stem cell transplant - PACT (Post-Allo Cyclophosphamide in Thalassemia)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/07/014826

Enrollment

Registered

2018-07-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- High-risk Thalassemia undergoing allogeneic stem cell transplant

Interventions

Intervention1: Cyclophosphamide: Post-transplant Cyclophosphamide 25mg/kg on Day +3 and +4 Cyclosporine 2.5mg/kg twice daily from Day +5 for 3mths and taper thereafter, to stop by 6months Control In

Eligibility

Inclusion criteria

Inclusion criteria: 1. Signed and dated written informed consent by start date of Screening visit in accordance with GCP and local legislation 2. Patients with High Risk Thalassemia (Defined as having both Age >7yrs and Liver size >5cm) who are planned for allogeneic stem cell transplantation.

Exclusion criteria

Exclusion criteria: 1. Cardiac dysfunction as assessed by ECHO and Cardiac MRI pre-transplant.

Design outcomes

Primary

Measure	Time frame
Incidence of chronic GVHD at 1 year (chronic GVHD defined according to NIH criteria)Timepoint: Incidence of chronic GVHD at 1 year (chronic GVHD defined according to NIH criteria)	—

Secondary

Measure	Time frame
Incidence and severity of acute GVHDTimepoint: Acute GVHD at 100 days CMV reactivation within 100 days 1 year EFS, OS and GVHD-free survival	—

Countries

India

Contacts

Public ContactVikram Mathews

Christian Medical College, Vellore

vikram@cmcvellore.ac.in04162282352

Outcome results

None listed

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