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Report for Clinical Trial NCT03678454

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Prospective Registry of Iclusig® (Ponatinib) Used in Clinical Practice for the Treatment of Patients With Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium

This prospective registry is initiated to follow up on the use of Iclusig® in patients with CML or Ph+ ALL in routine practice in Belgium.

NCT03678454 Chronic Myeloid Leukemia CML Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia Ph+ ALL
MeSH:Leukemia Leukemia, Myeloid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome
HPO:Chronic myelogenous leukemia Leukemia Lymphoid leukemia Myeloid leukemia


Primary Outcomes

Description: Prescribed dose of Iclusig® in milligrams.

Measure: Prescribed dose of Iclusig® in routine practice in Belgium

Time: Up to 3 years

Secondary Outcomes

Description: Includes treatment effectiveness, complete hematologic response, cytogenetic response, major molecular response.

Measure: Overall clinical benefit rate of Iclusig® based on response criteria for CML or Ph+ ALL in Belgium

Time: Up to 3 years

Description: Costs associated with the treatment of Iclusig®-related adverse events reported during the registry.

Measure: Estimate of additional health care utilization cost

Time: Up to 3 years

Time Perspective: Prospective

Other


There is one SNP

SNPs


1 T315I

Costs associated with the treatment of Iclusig®-related adverse events reported during the registry.. Inclusion Criteria: - Patient with confirmed diagnosis of: - CML (chronic, accelerated or blast phase) who is resistant or intolerant to dasatinib or nilotinib; and for whom subsequent treatment with imatinib is not clinically appropriate; or who has the T315I mutation. --- T315I ---

- Ph+ ALL who is resistant or intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who has the T315I mutation. --- T315I ---

Inclusion Criteria: - Patient with confirmed diagnosis of: - CML (chronic, accelerated or blast phase) who is resistant or intolerant to dasatinib or nilotinib; and for whom subsequent treatment with imatinib is not clinically appropriate; or who has the T315I mutation. --- T315I ---



HPO Nodes


HPO: