The use of a novel biological drug to prevent and treat chronic graft rejection in patients who have undergone a bone marrow transplant

A pilot study of itolizumab for the treatment of chronic graft vs host disease following haematopoietic stem cell transplantation.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/03/024056

Enrollment

Registered

2020-03-18

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: D899- Disorder involving the immune mechanism, unspecified

Interventions

Intervention1: Itolizumab: Inj. Itolizumab will be administered at a dose of 1.6 mg per kg body weight in 250ml normal saline over 4 hours as a slow infusion Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: Recipients of allogeneic hematopoietic stem cell transplantation (alloHSCT) using myeloablative or nonmyeloablative conditioning regimens Having clinical diagnosis of chronic GVHD extensively involving skin or Musculoskeletal system - NIH severity score 2 or above

Exclusion criteria

Exclusion criteria: -Patients who do not give consent to receive the treatment. -Patients who relapse after haematopoietic stem cell transplantation or have undergone 2nd transplantation for relapse. -Patients with high-risk malignancy requiring early taper of immunosuppressants. -Evidence of post-transplant lymphoproliferative disease.

Design outcomes

Primary

Measure	Time frame
Improvement in GVHD symptoms and the incidence of adverse events.Timepoint: 1 year	—

Secondary

Measure	Time frame
NilTimepoint: 1 year	—

Countries

India

Contacts

Public ContactDr Alben Sigamani

Mazumdar Shaw Medical centre

nataraj.ks.dr@narayanahealth.org9482141773

Outcome results

None listed

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