To Check Safety and Efficacy Abatacept vs Low dose ATG in Stem cell transplant patients

Open-labelled, Interventional, randomized, controlled trial of Abatacept vs. Low dose Rabbit ATG/ATLG used for prophylaxis of graft versus host disease (GVHD) with Post transplant cyclophosphamide and Tacrolimus based regimens for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) of Hematological malignancies (A2G) Trial - NA

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060233

Enrollment

Registered

2023-11-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Health Condition 1: D728- Other specified disorders of whiteblood cells

Interventions

Intervention1: Abatacept: Adding Abatacept will reduce GVHD in Stem cell transplant patients Abatacept 10 mg/kg will be given IV on days -1, + 5, + 14, + 28, Control Intervention1: Low dose ATG: Comp

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: All Patients who undergo HSCT for hematological malignancies. All patients and/or their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines. Exclusion Criteria: Serious psychiatric disease including schizophrenia, bipolar disorder and severe depression. Pregnancy (positive serum B-HCG) or breastfeeding. Known hypersensitivity reactions to Abatacept/ATG Method of randomization: simple (1:1) Method of allocation concealment: none, since this is an open-labelled study Expected date of first enrolment: 31st November 2023 Estimated duration of trial: 3 years Sponsor: none (Investigator initialed trial)

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Serious psychiatric disease including schizophrenia, bipolar disorder and severe depression. Pregnancy (positive serum B-HCG) or breastfeeding. Known hypersensitivity reactions to Abatacept/ATG

Design outcomes

Primary

Measure	Time frame
Incidence and severity of acute GVHD day +28, +60, +100, +180 and +365 Grade III-IV acute GVHD at day +28, +60, +100, +180 and +365 Incidence of steroid-refractory GVHD at day +28, +60, +100, +180 and +365 Incidence and severity of Chronic GVHD at day +100, +180 and +365 Timepoint: At Last follow up	—

Secondary

Measure	Time frame
At the last follow-up GRFS Incidence of opportunistic infections, such as: cytomegalovirus (CMV) reactivation, reactivation of other viral infections (EBV, etc.), bacterial sepsis Relapse of hematologic malignancies Timepoint: Till Last follow up	—

Countries

India

Contacts

Public ContactDr Sachin Suresh Jadhav

HCG Cancer Hospital

drsachinjadhav@hotmail.com9741351357

Outcome results

None listed

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