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

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

Sponsors

Lead sponsor: Bristol-Myers Squibb

Source Bristol-Myers Squibb
Brief Summary

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

Detailed Description

Cohort 2 was closed early to enrollment based on insufficient treatment response and poor enrollment

Overall Status Active, not recruiting
Start Date February 19, 2009
Completion Date September 23, 2021
Primary Completion Date September 1, 2016
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Major Cytogenetic Response (MCyR) Rate From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Complete Hematologic Response (CHR) Rate From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Complete Cytogenetic Response (CCyR) Rate From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Secondary Outcome
Measure Time Frame
Major Cytogenetic Response (MCyR) Rate in Cohort 2 From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3 From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Rate of Best Cytogenetic Response From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Time to Major Cytogenetic Response (MCyR) From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)
Duration of Major Cytogenetic Response (MCyR) From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)
Time to Complete Cytogenetic Response (CCyR) From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)
Duration of Complete Cytogenetic Response (CCyR) From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)
Progression-Free Survival (PFS) Rate at 2 Years 2 years
Time to Complete Hematologic Response (CHR) From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)
Duration of Complete Hematologic Response (CHR) From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)
Disease-Free Survival Rate at 2 Years 2 years
Overall Survival (OS) Rate at 2 Years 2 years
Major Molecular Response (MMR) Rate From date of first treatment to date of MMR (assessed up to September 2016, approximately 90 months)
Complete Molecular Response (CMR) Rate From date of first treatment to date of CMR (assessed up to September 2016, approximately 90 months)
Major Cytogenetic Response (MCyR) Rate up to 2 Years 24 months
Complete Cytogenetic Response (CCyR) Rate up to 2 Years 24 months
Major Molecular Response (MMR) Rate up to 2 Years 24 months
Complete Molecular Response (CMR) Rate up to 2 Years 24 months
Enrollment 145
Condition
Intervention

Intervention type: Drug

Intervention name: Dasatinib

Other name: Sprycel (BMS-354825)

Eligibility

Criteria:

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

- CP-CML who prove resistant or intolerant to imatinib (Cohort 1)

- Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (Cohort 2)

- Newly diagnosed, treatment naive CP-CML (Cohort 3)

- Lansky or Karnofsky scale >50

- Life expectancy ≥12 weeks

- Adequate hepatic and renal function

- Written informed consent

Exclusion Criteria:

- Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation

- Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease)

- Isolated extramedullary disease

- Prior therapy with Dasatinib

Gender: All

Minimum age: N/A

Maximum age: 18 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Location
facility
Phoenix Children'S Hospital | Phoenix, Arizona, 85016, United States
Jonathan Jaques Children'S Cancer Center | Long Beach, California, 90801-1428, United States
Children'S Hospital Of Orange County | Orange, California, 92868, United States
Children'S Hospital | Aurora, Colorado, 80045, United States
Children's Healthcare Of Atlanta - Egleston | Atlanta, Georgia, 30322, United States
Children's Hospital of Chicago | Chicago, Illinois, 60611, United States
Dana Faber Cancer Institute | Boston, Massachusetts, 02215, United States
Stephen D. Hassenfeld Children'S Center | New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center | New York, New York, 10065, United States
Oregon Health & Sci Univ | Portland, Oregon, 97239, United States
Children'S Hospital Of Philadelphia | Philadelphia, Pennsylvania, 19104-4318, United States
Children'S Hospital Of Pittsburgh | Pittsburgh, Pennsylvania, 15224, United States
MD Anderson Cancer Center | Houston, Texas, 77030-4009, United States
Texas Children'S Cancer Center | Houston, Texas, 77030, United States
Seattle Children'S | Seattle, Washington, 98105, United States
Local Institution | Bunos Aires, Buenos Aires, 1425, Argentina
Hospital Nacional Profesor Alejandro Posadas | El Palomar, Buenos Aires, 1684, Argentina
Local Institution | Cordoba, 5016, Argentina
Local Institution | Randwick, New South Wales, 2031, Australia
Local Institution | Westmead, New South Wales, 2145, Australia
Local Institution | Sth Brisbane, Queensland, 4101, Australia
Local Institution | North Adelaide, South Australia, 5006, Australia
Local Institution | Parkville, Victoria, 3052, Australia
Local Institution | Curitiba, Parana, 80060-900, Brazil
Local Institution | Porto Alegre, RIO Grande DO SUL, 90035-003, Brazil
Local Institution | Campinas, 13083-970, Brazil
Local Institution | Sao Paulo, 01401-000, Brazil
Local Institution | Sao Paulo, 04023-062, Brazil
Alberta Children'S Hospital | Calgary, Alberta, T3B 6A8, Canada
Stollery Children'S Hospital | Edmonton, Alberta, T6G 2B7, Canada
Bc Children'S Hospital | Vancouver, British Columbia, V6H 3V4, Canada
Iwk Health Centre | Halifax, Nova Scotia, B3K 6R8, Canada
Children'S Hospital Of Eastern Ontario | Ottawa, Ontario, K1H 8L1, Canada
The Hospital For Sick Children | Toronto, Ontario, M5G 1X8, Canada
Chu Ste-Justine | Montreal, Quebec, H3T 1C5, Canada
Local Institution | Lyon, 69008, France
Local Institution | Nantes, 44093, France
Local Institution | Paris Cedex 12, 75571, France
Local Institution | Paris, 75935, France
Local Institution | Poitiers, 86000, France
Local Institution | Frankfurt, 60590, Germany
Local Institution | Hannover, 30625, Germany
Local Institution | Navrangpura, Ahmedabad, Gujarat, 380009, India
Local Institution | Bangalore, Karnataka, 560027, India
Local Institution | Pune, Maharashtra, 411001, India
Local Institution | Madurai, Tamil NADU, 625107, India
Local Institution | Vellore, Tamilnadu, 632004, India
Local Institution | Kolkatta, 700 016, India
Local Institution | Mumbai, 400010, India
Local Institution | Trivandrum, 695011, India
Local Institution | Bologna, 40138, Italy
Local Institution | Monza (MB), 20900, Italy
Local Institution | Roma, 00161, Italy
Local Institution | Roma, 00165, Italy
Local Institution | Torino, 10126, Italy
Local Institution | Seoul, 05505, Korea, Republic of
Local Institution | Seoul, 137-701, Korea, Republic of
Local Institution | Df, Distrito Federal, 06720, Mexico
Local Institution | Mexico, D. F., Distrito Federal, 06726, Mexico
Local Institution | Mexico, Distrito Federal, 04530, Mexico
Hospital Civil De Guadalajara - Nuevo Dr. Juan I. Menchaca | Guadalajara, Jalisco, 44340, Mexico
Local Institution | Monterrey, N.l., Nuevo LEON, 64180, Mexico
Local Institution | Monterrey, Nuevo LEON, 64460, Mexico
Local Institution | Rotterdam, 3015 GJ, Netherlands
Local Institution | Bucharest, 022322, Romania
Local Institution | Moscow, 115478, Russian Federation
Local Institution | Moscow, 117198, Russian Federation
Local Institution | Saint-petersburg, 197022, Russian Federation
Local Institution | Singapore, 119228, Singapore
Local Institution | Bloemfontein, FREE State, 9301, South Africa
Local Institution | Pretoria, Gauteng, 0001, South Africa
Local Institution | Cape Town, Western CAPE, 7925, South Africa
Local Institution | Tygerberg, Western CAPE, 7505, South Africa
Local Institution | Barcelona, 08025, Spain
Local Institution | Barcelona, 08035, Spain
Local Institution | Madrid, 28009, Spain
Local Institution | Madrid, 28046, Spain
Local Institution | Malaga, 29010, Spain
Local Institution | Valencia, Spain
Local Institution | Glasgow, Central, G3 8SJ, United Kingdom
Local Institution | Sutton, Surrey, SM2 5PT, United Kingdom
Local Institution | Birmingham, WEST Midlands, B4 6NH, United Kingdom
Location Countries

Argentina

Australia

Brazil

Canada

France

Germany

India

Italy

Korea, Republic of

Mexico

Netherlands

Romania

Russian Federation

Singapore

South Africa

Spain

United Kingdom

United States

Verification Date

January 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Cohort 1: Imatinib-resistant/intolerant CP-CML

Arm group type: Experimental

Description: Dasatinib 60 mg/m² tablet every day (QD) [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² powder for oral suspension (PFSO) QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

Arm group label: Cohort 2: Ph+ALL or AP- or BP-CML

Arm group type: Experimental

Description: Dasatinib 80 mg/m² tablet QD [with a maximum dose of 140 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 96 mg/m² PFSO QD [with a maximum dose of 170 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

Arm group label: Cohort 3: Newly diagnosed, treatment naïve CP-CML

Arm group type: Experimental

Description: Dasatinib 60 mg/m² tablet QD [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² PFSO QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

Study Design Info

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov