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Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

Primary Purpose

Leukemia, Pediatric

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dasatinib
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Pediatric

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Inclusion Criteria:

  • Newly diagnosed Philadelphia chromosome positive Acute Lymphoblastic Leukemia (ALL)
  • Age >1 year and < less than 18 years old
  • Induction chemotherapy ≤ 14 days according to institutional standard of care
  • Adequate liver, renal and cardiac function

Exclusion Criteria:

  • Prior treatment with a Oncogene fusion protein (BCR-ABL) inhibitor
  • Extramedullary involvement of the testicles
  • Active systemic bacterial, fungal or viral infection
  • Down syndrome

Sites / Locations

  • University Of Alabama At Birmingham
  • Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.
  • University Of Arkansas For Medical Sciences
  • Antranik Agop Bedros
  • Miller Children's and Women Hospital
  • Children'S Hospital Of L.A.
  • Southern California Permanente Medical Group
  • Valley Children's Hospital
  • Children's Hospital of Orange County
  • Lpch & Sumc
  • Kaiser Medical Center
  • Ucsf - Hematology/Oncology
  • Children'S Hospital Colorado
  • Connecticut Children's Medical Center
  • A. I. Dupont Hospital For Children
  • Children'S National Medical Center
  • Lee Memorial Health System
  • University Of Florida
  • Nemours Children'S Clinic
  • Md Anderson Cancer Center Orlando
  • Nemours Childrens Hospital
  • All Children'S Hospital
  • St. Joseph's Children's Hospital
  • St. Mary'S
  • Children's Healthcare Of Atlanta
  • Kapiolani Medical Center For Women & Children
  • Mountain States Tumor Institute
  • Ann & Robert H Lurie Children's Hospital Of Chicago
  • Loyola University Medical Center
  • Southern Illinois University School Of Medicine
  • James Whitcomb Riley Hospital For Children
  • Children'S Center For Cancer And Blood Diseases
  • University Of Kentucky
  • Norton Children's Hospital
  • Sinai Hospital Of Baltimore
  • Johns Hopkins University
  • Dana Farber Cancer Institute
  • UMass Memorial Medical Center
  • Children'S Hospital Of Michigan
  • Helen Devos Children'S Hospital
  • Michigan State University
  • Childrens Hospitals And Clinics Of Minnesota
  • Univ Of Mississippi Med Ctr
  • University Of Missouri Health Care
  • Children'S Mercy Hospital And Clinics
  • Washington University Medical Center
  • Children'S Specialty Center Of Nevada
  • Hackensack University Medical Center
  • Goryeb Children'S Hospital
  • The Cancer Institute Of New Jersey
  • Newark Beth Israel Medical Center
  • St. Joseph's Regional Medical Center
  • University Of New Mexico
  • New York University
  • The Herbert Irving Pavilion
  • New York Presbyterian/Weill Cornell
  • SUNY Upstate Medical University
  • New York Medical College
  • Levine Children's Hospital
  • Wake Forest University
  • Cincinnati Children'S Hospital Medical Center
  • Nationwide Children'S Hospital
  • The Children'S Medical Center Of Dayton
  • The Toledo Children'S Hospital
  • Mercy Children's Hospital
  • University Of Oklahoma Health Sciences Center
  • Legacy Emanuel Hospital & Health Center
  • Oregon Health & Sci Univ
  • Geisinger Medical Center
  • Penn State Hershey Medical Center
  • Children'S Hospital Of Philadelphia
  • Children's Hospital Of Pittsburgh Of UPMC
  • Rhode Island Hospital
  • East Tennessee Children'S Hosp
  • Vanderbilt University
  • Dell Children'S Medical Center Of Central Texas
  • Driscoll Children'S Hospital
  • Ut Southwestern
  • Cook Children'S Hem/Onc Center
  • Texas Children'S Cancer Center
  • Scott & White - McLane Children's Specialty Clinic
  • Primary Children's Medical Center
  • Inova Pediatric Specialty Center Ii
  • Children'S Hosp-Kings Daughter
  • Seattle Children'S
  • St Vincent Hospital
  • Kenneth Desantes, Md
  • Medical College of Wisconsin
  • Local Institution
  • Local Institution
  • Local Institution
  • Alberta Children'S Hospital
  • Stollery Children'S Hospital
  • Local Institution
  • Children'S Hospital Of Eastern Ontario
  • Chu Ste-Justine
  • The Montreal Children's Hospital of the MUHC
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1: Dasatinib

Arm Description

Outcomes

Primary Outcome Measures

3-year Event-free Survival (EFS) Rate
3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment. Events for EFS are defined as ANY first one of the following: Lack of complete response in bone marrow Relapse at any site Development of second malignant neoplasm Death from any cause

Secondary Outcome Measures

Number of Participants Experiencing Adverse Events
Number of participants experiencing different types of all causality all grade adverse events
Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)
Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last.
Complete Remission Rate
Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. < 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants.
Percentage of Participants Negative for Minimal Residual Disease (MRD)
MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1%
Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse
A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR.

Full Information

First Posted
October 25, 2011
Last Updated
November 8, 2021
Sponsor
Bristol-Myers Squibb
Collaborators
Children's Oncology Group, EsPhALL
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1. Study Identification

Unique Protocol Identification Number
NCT01460160
Brief Title
Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
Official Title
A Phase 2 Multi-Center, Historically Controlled Study of Dasatinib Added to Standard Chemotherapy in Pediatric Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 13, 2012 (Actual)
Primary Completion Date
May 28, 2017 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Children's Oncology Group, EsPhALL

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Dasatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Intervention Description
Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
Primary Outcome Measure Information:
Title
3-year Event-free Survival (EFS) Rate
Description
3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment. Events for EFS are defined as ANY first one of the following: Lack of complete response in bone marrow Relapse at any site Development of second malignant neoplasm Death from any cause
Time Frame
From first dose to 3 years following first dose
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing Adverse Events
Description
Number of participants experiencing different types of all causality all grade adverse events
Time Frame
From first dose to 100 days following last dose (up to approximately 23 months)
Title
Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)
Description
Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last.
Time Frame
From first dose to 3 years or 5 years following first dose
Title
Complete Remission Rate
Description
Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. < 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants.
Time Frame
From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks)
Title
Percentage of Participants Negative for Minimal Residual Disease (MRD)
Description
MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1%
Time Frame
From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks)
Title
Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse
Description
A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR.
Time Frame
At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Newly diagnosed Philadelphia chromosome positive Acute Lymphoblastic Leukemia (ALL) Age >1 year and < less than 18 years old Induction chemotherapy ≤ 14 days according to institutional standard of care Adequate liver, renal and cardiac function Exclusion Criteria: Prior treatment with a Oncogene fusion protein (BCR-ABL) inhibitor Extramedullary involvement of the testicles Active systemic bacterial, fungal or viral infection Down syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University Of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
University Of Arkansas For Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Antranik Agop Bedros
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
Miller Children's and Women Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Children'S Hospital Of L.A.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Lpch & Sumc
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Kaiser Medical Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Ucsf - Hematology/Oncology
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0106
Country
United States
Facility Name
Children'S Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
A. I. Dupont Hospital For Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Children'S National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Lee Memorial Health System
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
University Of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Nemours Children'S Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Md Anderson Cancer Center Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Nemours Childrens Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
All Children'S Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33629
Country
United States
Facility Name
St. Joseph's Children's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
St. Mary'S
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Children's Healthcare Of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Kapiolani Medical Center For Women & Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Mountain States Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Ann & Robert H Lurie Children's Hospital Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Southern Illinois University School Of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9635
Country
United States
Facility Name
James Whitcomb Riley Hospital For Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5225
Country
United States
Facility Name
Children'S Center For Cancer And Blood Diseases
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University Of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
Norton Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Sinai Hospital Of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Children'S Hospital Of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Helen Devos Children'S Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Michigan State University
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Childrens Hospitals And Clinics Of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Univ Of Mississippi Med Ctr
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University Of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Children'S Mercy Hospital And Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Children'S Specialty Center Of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Goryeb Children'S Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
The Cancer Institute Of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
St. Joseph's Regional Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
University Of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
The Herbert Irving Pavilion
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York Presbyterian/Weill Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Levine Children's Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1081
Country
United States
Facility Name
Cincinnati Children'S Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Nationwide Children'S Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Children'S Medical Center Of Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404-1815
Country
United States
Facility Name
The Toledo Children'S Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Mercy Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
University Of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Legacy Emanuel Hospital & Health Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health & Sci Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-1320
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Children'S Hospital Of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4318
Country
United States
Facility Name
Children's Hospital Of Pittsburgh Of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
East Tennessee Children'S Hosp
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6310
Country
United States
Facility Name
Dell Children'S Medical Center Of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Driscoll Children'S Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Ut Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9063
Country
United States
Facility Name
Cook Children'S Hem/Onc Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Children'S Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott & White - McLane Children's Specialty Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Inova Pediatric Specialty Center Ii
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Children'S Hosp-Kings Daughter
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Seattle Children'S
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
St Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Kenneth Desantes, Md
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-2275
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution
City
Sth Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Local Institution
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Local Institution
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Alberta Children'S Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Stollery Children'S Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Local Institution
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Children'S Hospital Of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Chu Ste-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
The Montreal Children's Hospital of the MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Local Institution
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Local Institution
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution
City
Cagliari
ZIP/Postal Code
09121
Country
Italy
Facility Name
Local Institution
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Local Institution
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Local Institution
City
Genova
ZIP/Postal Code
16147
Country
Italy
Facility Name
Local Institution
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80123
Country
Italy
Facility Name
Local Institution
City
Palermo
ZIP/Postal Code
90134
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
Local Institution
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution
City
Trieste
ZIP/Postal Code
34137
Country
Italy
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00912
Country
Puerto Rico
Facility Name
Local Institution
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Local Institution
City
Cardiff
State/Province
Glamorgan
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Local Institution
City
Aberdeen
State/Province
Grampian
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
WC1N3JH
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Facility Name
Local Institution
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO9 4XY
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Local Institution
City
Edinburgh
State/Province
Lothian
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Facility Name
Local Institution
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Local Institution
City
Leeds
State/Province
North Yorkshire
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Local Institution
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Local Institution
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX 39DU
Country
United Kingdom
Facility Name
Local Institution
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
Local Institution
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Local Institution
City
Newcastle-upon-tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Local Institution
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33242441
Citation
Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

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