Drugs to reduce complications after transplant

To determine if the addition of Rabbit ATG [Thymoglobulin] to the conditioning regimen will reduce the incidence of acute graft versus host disease in adult patients undergoing Haplo-identical hematopoietic stem cell transplantation [Haplo-HSCT] Ã¢â?¬â?? a phase II multi-center Indian study - NA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/05/042441

Enrollment

Registered

2022-05-10

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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: Antithymocyte globulin - ATG(Thymoglobulin): Patients will receive ATG [Thymoglobulin] in the following manner - 0.5 mg/kg on Day -3 and then 2 mg/kg/day on Day -2 and -1 Control Inter

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients >18 years undergoing Haplo-identical transplantation 2.HaploSCT being performed for a malignant disorder 3.Must have life expectancy of > 6 months 4.Must be in remission or stable disease at the time of HaploSCT 5.No active infection at time of Haplo SCT 6.Adequate liver function Ã¢â?¬â?? ALT/AST 7.Adequate renal function Ã¢â?¬â?? creatinine 8.Willing to sign informed consent

Exclusion criteria

Exclusion criteria: 1.Paediatric patients undergoing Haplo-identical transplantation [ 2.Patients undergoing matched sibling or unrelated donor transplantation 3.Patients undergoing Haplo-identical transplant for non-malignant disorders 4.Use of other GVHD protocols other than PTCy 5.Presence of high titre of Donor specific antibodies [DSA].

Design outcomes

Primary

Measure	Time frame
To determine if the addition of low dose Anti-thymocyte globulin [ATG] to the conditioning regimen will reduce the incidence of acute graft versus host disease [GVHD] in adult patients undergoing haplo-identical HSCT.Timepoint: Weekly for first 3 months	—

Secondary

Measure	Time frame
a.To study the rates of infection [bacterial, viral, and fungal] in this study cohort. b.To study the incidence of chronic graft versus host disease in this study cohort. c.To study the cumulative incidence of relapse d.To compare all the above parameters with a historical cohort matched for age, disease risk index [DRI] and conditioning regimen who did not receive ATGTimepoint: 2 years	—

Countries

India

Contacts

Public ContactBiju George

Christian Medical College

biju@cmcvellore.ac.in04162282352

Outcome results

None listed

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