Skip to content

Study that only studies information for overcoming barriers and successfully implementing a free-of-cost Blinatumomab (immunotherapy medicine given in treatment of relapsed Acute Lymphoblastic Leukemia) facilitation program in a Low and Middle-Income countries like India

Implementing Novel Agents and Translating Innovation Globally: A Non- Therapeutic Project to Facilitate Implementation of Novel Therapeutic Agents in Low and Middle-Income Countries with the Blincyto Humanitarian Access Program - INOVATING

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/08/056146
Enrollment
80
Registered
2023-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: Z511- Encounter for antineoplastic chemotherapy and immunotherapy

Interventions

Intervention1: Not applicable: Not applicable Control Intervention1: Not applicable: Not applicable

Sponsors

Tata Memorial Centre
Lead Sponsor
St Jude Childrens Research Hospital
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. All stakeholders (Healthcare Professionals involved in administration of Blinatumomab) 2. All the patients and their caregivers receiving Blinatumomab therapy

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
1 The barriers & facilitators to blinatumomab implementation in LMIC, including pilot site infrastructure score, climate score & readiness score, & score of perceived intervention complexity 2 The implementation outcomes: feasibility, acceptability, appropriateness, fidelity 3 Relative importance and feasibility of discrete implementation strategies 4 Adequacy of training programs as defined by Training Material Feedback, Provider Specific Knowledge Assessment, and surrogate clinical measuresTimepoint: The interviews will be conducted after start of the treatment as the Blinatumomab is ongoing through the Blincyto Humanitarian Access Program, administered to the pediatric patients at baseline and during the therapy, at the end of therapy and 6 months survival data will be collected. Data from care providers will be collected once after initiation of the study at baseline and after providing training at 3 months and after 1 year via web-based systems designed and maintained by St. Jude.

Secondary

MeasureTime frame
NoneTimepoint: None

Countries

India, Pakistan, Viet Nam

Contacts

Public ContactDr Gaurav Narula

Tata Memorial Hospital

drgauravnarula@gmail.com02224176761

Outcome results

None listed

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