Molecular and Pharmacogenetic Marker Evaluation in Relation to the Toxicity and Clinical Response of Acute Lymphoblastic Leukemia Treatment in Indian Children (MPGx-INDALL)

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: f
View:

• Age \> 1 year old and ≤18 years old at enrolment

• Previously untreated

• ALL diagnosis confirmed by morphology and flow-cytometry

• Indian origins

• Fulfilling IciCle treatment protocol inclusion criteria and receiving treatment as per the protocol

• Written Informed consent to participate in the study has to be signed by the participant/parent/guardian

Locations
Other Locations
India
Dr. Sameer Bakhshi
RECRUITING
New Delhi
Dr. Biswajit Dubashi
RECRUITING
Puducherry
Contact Information
Primary
Chakradhara Rao S Uppugudnuri
chakradhara.uppugunduri@unige.ch
+41223794685
Backup
Marc Ansari
Marc.Ansari@hcuge.ch
+41223724731
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 500
Treatments
Newly diagnosed ALL Children with age group of >1 and ≤18 years old
Newly diagnosed ALL Children who are likely to receive anti-cancer drugs or chemotherapy as a part of IciCLE treatment protocol.
Sponsors
Collaborators: Jawaharlal Institute of Postgraduate Medical Education & Research, All India Institute of Medical Sciences, CANSEARCH Foundation, Swiss National Science Foundation, Ministry of Science and Technology, India
Leads: University of Geneva, Switzerland

This content was sourced from clinicaltrials.gov