Phase II Clinical trail on Chronic myelogenous leukemia (cancer of while blood cells) in children from 2 years to 18 years of age.

A Phase II Study of Dasatinib Therapy in Children and Adolescents with Newly Diagnosed Chronic Phase CML or with Ph+ Leukemias Resistant or Intolerant to Imatinib

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/08/001975

Enrollment

110

Registered

2011-08-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Myelogenous Luekemia

Interventions

Intervention1: Dasatinib: Available as tablets,Oral route of adminstration, Once dialy dose and duration of 02 years Intervention2: Dasatanib in Cohort 1: Treated with dasatinib 60 mg/m2(Patients with

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criterias: 1)Age 2 to 18 years. 2)Lansky or Karnofsky scale >50. 3)Life expectancy more than 12 weeks. 4)Any toxicity from recent therapies recovered to baseline or grade 1. 5)Adequate hepatic and renal function.

Exclusion criteria

Exclusion criteria: Prior therapy with dasatinib Eligible for potentially curative therapy including hematopoietic stem-cell transplantation Symptomatic central nervous system disease Isolated extramedullary disease Medical condition significantly impairing ability of patient to receive dasatinib T315I mutation in BCR-ABL

Design outcomes

Primary

Measure	Time frame
Cohort1 :CP-CML resistant or intolerant to imatinib:MCyR rate Cohort2: AP/BP-CML or Ph+ ALL resistant or intolerant to imatinib:CHR rate Cohort3: Newly diagnosed CP-CML:CCyR rate Timepoint: 24 months	—

Secondary

Measure	Time frame
Safety and tolerability Hematologic, cytogenetic, and molecular response rates Time to and duration of responses Disease-free, progression-free, and overall survival Evaluation of BCR-ABL mutations Timepoint: 24 months	—

Countries

Argentina, Australia, Brazil, Canada, France, Germany, India, Italy, Mexico, Netherlands, Romania, Russian Federation, Singapore, South Africa, Spain, United Kingdom, United States of America

Contacts

Public ContactSubashri Shivkumar

Medical Director

manish.mistry@bms.com02266288600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026