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Dasatinib Versus Nilotinib for Treatment Naïve Chronic Myeloid Leukemia

NCT03079505 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-01-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Mohamed A Yassin · Hamad Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-03
Primary Completion
2018-09-23
Completion
2018-09-23
FDA Drug
Yes

Countries

  • Qatar

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03079505 on ClinicalTrials.gov