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Half matched transplant in thalassemia

Establishing a platform for Haplo-identical transplant with Alpha Beta depletion in Children with Thalassaemia major (HACT study) - HACT

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021273
Enrollment
25
Registered
2019-09-17
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: D758- Other specified diseases of bloodand blood-forming organs

Interventions

Intervention1: αβ T cell depletion: Fludarabine 40 mg/m2/day x 4 days [Days -5 to -2] Thiotepa 8 mg/Kg IV on Day - 6 Treosulfan 14 G/m2/day x 3 days [days â?? 5 to -3] Thymoglobulin 1.5 mg/kg/day

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with Class I, II and Class III low risk thalassaemia 2.Adequate cardiac, hepatic and renal function 3.Absence of a matched sibling donor or a matched unrelated donor

Exclusion criteria

Exclusion criteria: 1.Class III high risk thalassaemia 2.Poor cardiac, hepatic or renal functions [ > 4 times ULN]

Design outcomes

Primary

MeasureTime frame
To study the 1 year overall survival in patients undergoing haplo-identical transplantation for Thalassaemia major using a Treosulfan based regimenTimepoint: 12 months

Secondary

MeasureTime frame
1.To study the incidence of acute and chronic graft versus host disease in patients undergoing Haplo-identical HSCT. 2.To study the pattern of immune reconstitution following Haplo-identical HSCT. 3.To study the risk of infectious complications following haplo-identical HSCT. 4.To study the incidence of primary and secondary graft failure following haplo-identical HSCT.Timepoint: 30days, 60days, 90days, 180days and 360days

Countries

India

Contacts

Public ContactBiju George

Christian Medical College, Vellore

biju@cmcvellore.ac.in04162282352

Outcome results

None listed

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