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To observe and to find out the side effects encountered on administering immunotherapies that are administered to modify the CD-19 (type of immunity cells) cells in children and adolescent patients having lymphoid cancer (type of blood cancer)

PROFILING RESPONSES AND TOXICITIES IN CD19-DIRECTED IMMUNOTHERAPIES FOR PEDIATRIC, ADOLESCENT AND YOUNG ADULT (P-AYA) LYMPHOID MALIGNANCIES

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/04/032794
Enrollment
25
Registered
2021-04-13
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: C910- Acute lymphoblastic leukemia [ALL]

Interventions

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

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Relapsed/Refractory B ALL patients in the age group between 1 and 25 years who have already been already Enrolled in an approved trial of CD19-directed CAR T-cell Therapy OR Counselled for and consented to receive Blinatumomab as standard of care therapy for appropriate indications

Exclusion criteria

Exclusion criteria: Not consenting to this study

Design outcomes

Primary

MeasureTime frame
To correlate host and disease-related biological factors with clinical profiles of patients with relapsed/refractory B-ALL prospectively treated with CD19- directed Immunotherapies (CAR T cell therapy and Blinatumomab)Timepoint: At Baseline, during the administration of the immunotherapy (CAR T cell therapy and Blinatumomab) and 1 year period post receiving CD19-directed immunotherapies

Secondary

MeasureTime frame
-To study overall response rates - CR or CRi or PR -To study survival of patients at the end of one year (RFS, PFS, EFS and OS)Timepoint: Till 1 year after completion of immunotherapy

Countries

India

Contacts

Public ContactDr Swaminathan K

HBNI and Tata Memorial Hospital

drgauravnarula@gmail.com022-24177000

Outcome results

None listed

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