NCT03079505

Dasatinib Versus Nilotinib for Treatment Naïve Chronic Myeloid Leukemia

Dasatinib Versus Nilotinib as Upfront Therapy for Treatment Naïve Chronic Myeloid Leukemia Chronic Phase

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Hamad Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

DANIN study is a randomized, phase 3 clinical trial comparing 'head to head' Nilotinib versus Dasatinib as upfront therapy for patient with chronic myeloid leukemia. The efficacy of both drugs will be tested by measuring BCR/ABL (BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL (Abelson proto-oncogene)) using European Leukemia net recommendations the study will be conducted in NCCCR (National Center for Cancer Care \& Research) sample size calculations detailed in the statistic part the clinical hematologist will recruit the patients this will include consenting process inclusion and exclusion criteria the molecular pathologist will do the molecular testing the clinical research coordinator and fellows will do the CRF (Case Report Form) as well as quality of life questionnaire and applying the protocol for evaluation of cardiac evaluation Molecular monitoring of BCR-ABL1 transcripts to assess treatment response in CML (Chronic Myeloid Leukemia).

Conditions

• Chronic Myeloid Leukemia - Chronic Phase

Interventions

Type	Name	Description
DRUG	Dasatinib 100 MG [Sprycel]	Dasatinib (Sprycel) 100 milligram, once-daily (QD) will be given to 25 patients orally
DRUG	Nilotinib 150mg oral capsule [Tasigna]	Nilotinib (Tasigna) 300 milligram, twice-daily (BID) will be given to 25 patients orally

Timeline

• Start date: 2017-08-03
• Primary completion: 2018-09-23
• Completion: 2018-09-23
• First posted: 2017-03-14
• Last updated: 2019-01-23

Locations

1 site across 1 country: Qatar

Regulatory

• FDA-regulated drug study