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Report for Clinical Trial NCT02810990
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
The objective of the present study is to evaluate a new drug called bosutinib as it is
believed that this agent may be able to predict an excellent prognosis in patients that did
not obtain any benefit with other drugs before. Still, this needs to be proved and we hope
this study is able to do so.
Name: Bosutinib
Description: Bosutinib is given orally accordingly with this scheme:
A. 200 mg OD: starting dose ("wash-in" period) at week 1 and week 2 B. 300 mg OD: from week 3 to the end of week 16
At the end of week 12 evaluation of molecular response (BCR-ABL1 level by RT-Q-PCR).
Bosutinib dose is then managed as follows :
C1. if BCR-ABL1 ≤1% at week 12: 300 mg OD from week 17 to week 52 C2. if BCR-ABL1 > 1% at week 12: 400 mg OD from week 17 to week 52
All the responsive patients who are still on Bosutinib at the end of week 52, will continue Bosutinib at the same dose (300 mg OD or 400 mg OD) for the next two years ( if tolerated and in absence of safety concerns).
Type: Drug
Group Labels: 1 Bosutinib treatment
Primary Outcomes
Measure: Number of patients who are in major molecular response (MMR) Time: One year treatment
Secondary Outcomes
Measure: Number of patients who obtain molecular response Time: At 6 and 12 months from treatment start
Measure: Number of patients discontinuing treatment for failure, adverse events or other reasons Time: At 12 and 36 months
Measure: Number of Adverse Events (AEs) Time: At 36 months
Measure: Number of patients alive Time: At 36 months
Measure: Number of patients on treatment at 200, 300 and 400 mg or more daily Time: At 6, 12 and 36 months
Measure: Number and type of BCR-ABL1 mutations Time: At 36 months
Measure: Patient reported quality of life Time: At 3, 6, and 12 months
Purpose: Treatment
Allocation: N/A
Single Group Assignment
There are 2 SNPs
SNPs
1 T315I
Exclusion Criteria:
1. Accelerated or blastic phase CML (according to ELN 2013 criteria)
2. Patients with the T315I or the V299L mutation
3. Patients previously treated with 2 TKIs or more
4. Compelled to take medications that are known to be associated with Torsades de Pointes
and/or with significant QTc prolongation
5. Any condition or illness that, in the opinion of the Investigator, would compromise
patient safety or interfere with the evaluation of the drug
6. --- T315I ---
2 V299L
Exclusion Criteria:
1. Accelerated or blastic phase CML (according to ELN 2013 criteria)
2. Patients with the T315I or the V299L mutation
3. Patients previously treated with 2 TKIs or more
4. Compelled to take medications that are known to be associated with Torsades de Pointes
and/or with significant QTc prolongation
5. Any condition or illness that, in the opinion of the Investigator, would compromise
patient safety or interfere with the evaluation of the drug
6. --- T315I --- --- V299L ---
HPO Nodes
HPO: