Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic VOD in Children With Nephroblastoma or ALL

Acute Lymphoblastic Leukemia Clinical Trial

— MVO  

Official title:

Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic Veno-occlusive Disease in Children With Nephroblastoma or Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04168788
• Other study ID #: 49RC19_0197
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: October 2019
• Source: University Hospital, Angers
• Contact: Denise Jolivot, MD
• Phone: 33-(0)2-41-35-58-08
• Email: DeJolivot[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hepatic veno-occlusive diseases (VOD) during cancer treatment in children are serious toxicities that have occurred with interruptions of chemotherapy and risk of relapse. In addition, these toxicities have a negative impact on the patient's quality of life, serious long-term sequelae and are potentially fatal in children.

The risk factors associated with the occurrence of these complications are, to date, unknown, at the exception to the exposition to certain treatments (6-thioguanine, busulfan, actinomycin D, radiotherapy, etc.). To understand the effects of this toxicity and those of susceptibility to the disease becomes a major issue in the treatment of these children.

Description:

Case-control study, nested in two French multicenter cohorts, on pharmacognenetic, biological and clinical susceptibility factors associated with the occurrence of hepatic veno-occlusive disease during the anticancer treatment for nephroblastoma or acute lymphoblastic leukemia, with centralized genetic analysis.

After obtaining consent (patient or parents for minor patients), a blood sample is collected during the routine follow-up consultation and tubes are sent directly to Paris for the pharmacogenetic analysis at the end of the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

• Children aged < 18 years old at the time of cancer diagnosis

• Having been treated with a single line of treatment for nephroblastoma or ALL, in France between 2000 and 2018, and who did not receive allogeneic hematopoietic stem cell transplantation

• Weight greater than 5 kg at inclusion

• Informed consent dated and signed by the holder of the parental authority (if minor) or by the patient (if major) to take part in the study

• Affiliated to a Social Security scheme

Exclusion Criteria:

• Unavaibility of constitutional DNA

• Person who receive more than one treatment line for nephroblastoma or ALL in childhood or adolescence

• Pregnant, lactating or parturient women

• Person deprived of their liberty by judicial or administrative decision

• Person under psychiatric care under duress

• Person subject to legal protection

• Person unable to express their consent

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Hepatic Veno-Occlusive Disease
• Leukemia
• Leukemia, Lymphoid
• Nephroblastoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Wilms Tumor

Intervention

Other:
• Blood test for genetic analysis
Drawing blood to realize a genetic analysis for susceptibility to hepatic VOD.

Locations

Country	Name	City	State
France	Univesity Hostipal of Amiens	Amiens
France	University Hospital of Bordeaux	Bordeaux
France	University of Brest	Brest
France	University Hospital of Dijon	Dijon
France	Centre Oscar Lambret	Lille
France	University Hospital of Limoges	Limoges
France	Hôpital La Timone	Marseille
France	University Hospital of Nantes	Nantes
France	University Hospital of Nice	Nice
France	Hôpital Trousseau	Paris
France	Institut Curie	Paris
France	University Hospital of Poitiers	Poitiers
France	University Hospital of Rennes	Rennes
France	University Hospital of La Réunion	Saint-Denis
France	University Hospital of Tours	Tours
France	Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlate pharmacogenetic analysis with veno-occlusive disease.	Illumina's "Human Omni2.5-8 v1.3" microarrays explore more than 2,600,000 genetic variants, thus covering the entire genome with more than 300,000 genetic biomarkers in exons.	One day
Secondary	Participant characteristics.	Age, sociodemographics, personal and cancer history.	One day