Pharmacogenomics of Asparaginase Induced Hepatotoxicity
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/21/2018 |
| Start Date: | February 25, 2019 |
| End Date: | February 25, 2025 |
| Contact: | Christine Duran |
| Email: | Duran_C@med.usc.edu |
| Phone: | 323-865-0371 |
Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
This pilot trial studies the impact of genetic information on developing liver damage caused
by asparaginase in participants with newly diagnosed acute lymphoblastic leukemia. Testing
saliva samples may help doctors find certain genetic markers that may predict whether
participants will tolerate asparaginase, which is given as part of clinical care for acute
lymphoblastic leukemia.
by asparaginase in participants with newly diagnosed acute lymphoblastic leukemia. Testing
saliva samples may help doctors find certain genetic markers that may predict whether
participants will tolerate asparaginase, which is given as part of clinical care for acute
lymphoblastic leukemia.
PRIMARY OBJECTIVES:
I. To establish the association between the SOD2 rs4880 genotypes and asparaginase-induced
hepatotoxicity in Hispanic patients.
II. To identify novel single nucleotide polymorphisms (SNPs) that are associated with
asparaginase induced hepatotoxicity.
OUTLINE:
Participants' SOD2 rs4880 SNP genotype (based on saliva from buccal swabs) will be
classified. Participants with the CC genotype will be compared to participants with the CT or
TT genotype. Buccal swabs of prospective participants' saliva will be collected when
participant achieves complete remission (during regular clinical visit). Retrospective
participants will be identified through search of pharmacy records for those who received
asparaginase within the last 5 years (2012-2017). Recurrent patients will be consented during
their regular clinical visits and samples will be collected.
I. To establish the association between the SOD2 rs4880 genotypes and asparaginase-induced
hepatotoxicity in Hispanic patients.
II. To identify novel single nucleotide polymorphisms (SNPs) that are associated with
asparaginase induced hepatotoxicity.
OUTLINE:
Participants' SOD2 rs4880 SNP genotype (based on saliva from buccal swabs) will be
classified. Participants with the CC genotype will be compared to participants with the CT or
TT genotype. Buccal swabs of prospective participants' saliva will be collected when
participant achieves complete remission (during regular clinical visit). Retrospective
participants will be identified through search of pharmacy records for those who received
asparaginase within the last 5 years (2012-2017). Recurrent patients will be consented during
their regular clinical visits and samples will be collected.
Inclusion Criteria:
- Newly diagnosed with acute lymphoblastic leukemia (ALL) - no prior treatment for ALL
- Receiving asparaginase as part of the primary treatment regimen
- Ability to understand and the willingness to sign a written informed consent
- For retrospective recruitment, those who have received asparaginase between 2012 and
2017; and are current patients of University of Southern California (USC)
Exclusion Criteria:
- Patients who are unable to give informed consent
We found this trial at
1
site
1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Houda Alachkar
Phone: 323-442-2696
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
Click here to add this to my saved trials
