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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05512169
Other study ID # MPGx-INDALL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2022
Est. completion date March 30, 2026

Study information

Verified date February 2024
Source University of Geneva, Switzerland
Contact Chakradhara Rao S Uppugudnuri
Phone +41223794685
Email chakradhara.uppugunduri@unige.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL). The project is an International multicenter setup. This collaborative research project between Switzerland and India includes one main center in Geneva that has conceptualized, designed, received grants for the study and two investigating centers in India (Puducherry and New-Delhi) involved in study design, patient care and recruitment for this specific study. All the participants for the study will be recruited form these two centers in India, and no patient recruitment is planned at main center i.e. Geneva. The study will be conducted in two phases. The first aims to investigate genetic predisposition (static germline variants) to early chemotherapy treatment related toxicities (TRTs). The second aims to investigate somatic genetic markers associated with the efficacy of steroid treatment among patients undergoing the standardized IciCLe-ALL-14 treatment protocol. A total of 500 children with ALL will be recruited to investigate primary objective of the study i.e. TRT, and a subset of 250 patients will be included to investigate another research question i.e. response to steroid therapy.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
India Dr. Sameer Bakhshi New Delhi
India Dr. Biswajit Dubashi Puducherry

Sponsors (6)

Lead Sponsor Collaborator
University of Geneva, Switzerland All India Institute of Medical Sciences, New Delhi, CANSEARCH Foundation, Jawaharlal Institute of Postgraduate Medical Education & Research, Ministry of Science and Technology, India, Swiss National Science Foundation

Country where clinical trial is conducted

India, 

References & Publications (1)

Kodidela S, Dorababu P, Thakkar DN, Dubashi B, Sundaram R, Muralidharan N, Nidanapu RP, Aribandi A, Pradhan SC, Uppugunduri CRS. Association of NUDT15*3 and FPGS 2572C>T Variants with the Risk of Early Hematologic Toxicity During 6-MP and Low-Dose Methotr — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative incidences of early treatment related adverse events as assessed by CTCAE v5.0 Drug-related toxicity = grade 3 occurring from the first day of induction until the middle of maintenance therapy.
Cumulative incidences of neutropenia from day 1 of maintenance to day 100 of maintenance therapy.
Incidences of multiple drug related adverse events of grade 3 and above as assessed by CTCAE v5.0 before day 100 of maintenance phase.
Incidences of 14 severe acute toxic effects as defined by Ponte di Legno toxicity working group consensus definitions (Ref: Lancet Oncol 2016;17:e231-e239)
Drug causality for the adverse event and grade at onset , maximum grade, and date of resolution will be considered.
Assessment of biochemical tests to consider for toxicity assessment as per CTCAE criteria will be performed every week until the maintenance phase, and then once in two weeks from day 1 to day 100 of maintenance phase.
10-12 months varying depnding upon the risk category
Primary Disease response to the treatment during induction phase to steroids Prednisolone response on day 8th of the induction: Good response if peripheral blast count <1000/uL or Poor response if it is > 1000 /uL. Day 8 of induction phase
Primary Disease response to the treatment during induction phase Bone marrow on Day 35: in remission = <5% blasts ; 5-25% blasts= M2 marrow; >25% blasts= M3 marrow
MRD (flow cytometry) testing on Day 35: =>0.01 % = high MRD ; <0.01% negative MRD
Day 35 of induction phase
Secondary Assessment of quality of life using Pediatric Quality of Life Inventory questionnaires Pediatric Quality of Life InventoryTM Generic Core version 4.0 and Pediatric Quality of Life InventoryTM Cancer Module Version 3.0 (translated and validated in local language i.e. Hindi and Tamil ).
Both questionnaires are scored from minimum of 0 to maximum 100 with higher scores indicating higher health related quality of Life.
will be used for quality of life assessment at the time of diagnosis, end of induction, beginning of maintenance phase and at day 100 of maintenance phase.
10-12 months
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