Trial Title:
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
NCT ID:
NCT05848687
Condition:
Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Dexamethasone
Methotrexate
Bortezomib
Asparaginase
Mitoxantrone
Mercaptopurine
Vorinostat
Blinatumomab
Pegaspargase
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Given orally (PO) or naso-gastrically (NG) or intravenously (IV).
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Mitoxantrone
Description:
Given IV
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
PEG asparaginase
Description:
Given IV
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Bortezomib
Description:
Given IV
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Vorinostat
Description:
Taken PO or NG
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Mercaptopurine
Description:
Given PO or NG.
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Methotrexate
Description:
Given IV, IM or PO
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Blinatumomab
Description:
Will be administered at 15 mcg/m2/day for 28 days following induction and reinduction
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Ziftomenib
Description:
3+3 dose escalation will be done. Dose level 1 will start at 75% of the adult recommended
phase two dosing which has been established in phase I studies. Based on tolerability, we
will either de-escalate to 50% RP2D (dose level -1) or escalate to 100% RP2D
Arm group label:
Treatment
Summary:
The purpose of this study is to improve upon the TINI study treatment. The study will
test the ability of a type of immunotherapy called blinatumomab to clear persistent
leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer
membrane.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient is ≤ 365 days of age at the time of diagnosis.
- Patient has newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) or
acute undifferentiated leukemia. Subjects with bilineage or biphenotypic acute
leukemia are eligible provided they express CD19. Patients with CD19 positive mature
B-cell ALL who carry a KMT2A rearrangement are eligible.
- Limited prior therapy, including hydroxyurea for 72 hours or less, systemic
glucocorticoids for one week or less, cytarabine for 72 hours or less, one dose of
vincristine, and one dose of intrathecal chemotherapy.
- Written informed consent following Institutional Review Board, NCI, FDA, and OHRP
Guidelines.
Exclusion Criteria:
- Patients with prior therapy, other than therapy specified in inclusion criteria.
- Patients with mature B-cell ALL that do not have a KMT2A rearrangement or patients
with acute myelogenous (AML) or T-cell ALL.
- Patients with Down syndrome.
- Inability or unwillingness of legal guardian/representative to give written informed
consent
Gender:
All
Minimum age:
N/A
Maximum age:
1 Year
Healthy volunteers:
No
Locations:
Facility:
Name:
Phoenix Children's Hospital
Address:
City:
Phoenix
Zip:
85016
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Chris Oless, RN
Phone:
602-933-0920
Email:
coless@phoenixchildrens.com
Investigator:
Last name:
Dana Salzberg, MD
Email:
Principal Investigator
Facility:
Name:
Arkansas Children's Hospital
Address:
City:
Little Rock
Zip:
72202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kevin Bielamowicz, MD
Phone:
501-364-4405
Email:
kjbielamowicz2@uams.edu
Investigator:
Last name:
Kevin Bielamowicz, MD
Email:
Principal Investigator
Facility:
Name:
Children's Hospital Los Angeles
Address:
City:
Los Angeles
Zip:
90027
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Paul S Gaynon, MD
Email:
pgaynon@chla.usc.edu
Contact backup:
Phone:
323-361-4624
Email:
pgaynon@chla.usc.edu
Investigator:
Last name:
Paul S Gaynon, MD
Email:
Principal Investigator
Facility:
Name:
Valley Children's Hospital
Address:
City:
Madera
Zip:
93636
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Faisal Razzaqi, MD
Phone:
559-353-3000
Email:
FRazzaqi@valleychildrens.org
Investigator:
Last name:
Faisal Razzaqi, MD
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Orange County
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jamie N Frediani, MD
Phone:
714-266-1672
Email:
jfrediani@choc.org
Investigator:
Last name:
Jamie N Frediani, MD
Email:
Principal Investigator
Facility:
Name:
Stanford University
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tanja A Gruber, MD, PhD
Phone:
650-723-5535
Email:
tagruber@stanford.edu
Facility:
Name:
Rady Children's Hospital San Diego
Address:
City:
San Diego
Zip:
92123
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Deborah Schiff, MD
Phone:
858-966-5811
Email:
dschiff@rchsd.org
Investigator:
Last name:
Deborah Schiff, MD
Email:
Principal Investigator
Facility:
Name:
Arnold Palmer Hospital for Children
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Claudia Zapata, MD
Phone:
321-841-8588
Email:
mailto:claudia.zapata@orlandohealth.com
Investigator:
Last name:
Claudia P Zapata, MD
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Minnesota
Address:
City:
Minneapolis
Zip:
55404
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Michael K Richards, MD, PhD
Phone:
612-813-5940
Email:
michael.richards@childrensmn.org
Investigator:
Last name:
Michael K Richards, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Minnesota
Address:
City:
Minneapolis
Zip:
55404
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Pauline Mitby
Phone:
612-813-5913
Email:
pauline.mitby@childrensmn.org
Investigator:
Last name:
Michael K Richards, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Tanya Trippett, MD
Phone:
212-639-8267
Email:
trippet1@mskcc.org
Investigator:
Last name:
Tanya Trippett, MD
Email:
Principal Investigator
Facility:
Name:
Novant Health - Hemby Children's Hospital
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Christine Bolen, MD
Phone:
704-384-1900
Email:
cybolen@novanthealth.org
Investigator:
Last name:
Christine Bolen, MD
Email:
Principal Investigator
Facility:
Name:
Doernbecher Children's Hospital
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Bill Hoon Chang, Md, PhD
Phone:
503-346-0640
Email:
changb@ohsu.edu
Investigator:
Last name:
Bill Hoon Chang, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Penn State Milton S Hershey Medical Center
Address:
City:
Hershey
Zip:
17033-0850
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Valerie Brown, MD,PhD
Phone:
717-531-6012
Email:
vbrown1@hmc.psu.edu
Investigator:
Last name:
Valerie Brown, Md, PhD
Email:
Principal Investigator
Facility:
Name:
MD Anderson
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
David McCall, MD
Phone:
717-792-6604
Email:
dmccall1@mdanderson.org
Facility:
Name:
University of Texas Health Science Center San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Anne-Marie Langevin, MD
Phone:
210-567-7460
Email:
langevin@uthscsa.edu
Investigator:
Last name:
Anne-Marie Langevin, MD
Email:
Principal Investigator
Facility:
Name:
University of Utah Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84108
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
David S Mangum, MD
Phone:
801-662-4700
Email:
Spencer.Mangum@hsc.utah.edu
Investigator:
Last name:
David Mangum, MD
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of the King's Daughters
Address:
City:
Norfolk
Zip:
23507
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Eric Lowe, MD
Phone:
757-668-7243
Email:
Eric.Lowe@chkd.org
Investigator:
Last name:
Eric Lowe, MD
Email:
Principal Investigator
Facility:
Name:
University of Wisconsin Carbone Cancer Center
Address:
City:
Madison
Zip:
53705
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Cathy Lee-Miller, MD
Phone:
602-263-1618
Email:
calee4@wisc.edu
Investigator:
Last name:
Cathy Lee-Miller, MD
Email:
Principal Investigator
Facility:
Name:
Alberta Children's Hospital
Address:
City:
Calgary
Zip:
T3B 6A8
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Victor Lewis
Phone:
1-403-955-7203
Email:
Victor.Lewis@albertahealthservices.ca
Investigator:
Last name:
Victor Lewis, MD
Email:
Principal Investigator
Facility:
Name:
Stollery Children's Hospital
Address:
City:
Edmonton
Zip:
T6G 2B7
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Sunil Desai
Phone:
1-780-407-8798
Email:
Sunil.Desai@albertahealthservices.ca
Investigator:
Last name:
Sunil J Desai, MD
Email:
Principal Investigator
Facility:
Name:
BC Children's Hospital
Address:
City:
Vancouver
Zip:
V6H 3V4
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Rebecca Deyell, MD
Phone:
1-604-875-2345
Email:
RDeyell@cw.bc.ca
Investigator:
Last name:
Rebecca Deyell, MD
Email:
Principal Investigator
Facility:
Name:
McMaster Children's Hospital
Address:
City:
Hamilton
Zip:
L8N 3Z5
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Uma Athale, MD
Phone:
1-905-525-9140
Email:
athaleu@mcmaster.ca
Investigator:
Last name:
Uma Athale, MD
Email:
Principal Investigator
Facility:
Name:
CHU Sainte-Justine
Address:
City:
Montréal
Zip:
H3T 1C5
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Thai Hoa Tran, MD
Phone:
1-514-345-4931
Email:
thaihoa.tran@recherchestejustine.qc.ca
Investigator:
Last name:
Thai Hoa Tran, MD
Email:
Principal Investigator
Facility:
Name:
Montreal Children's Hospital
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Catherine Vezina, MD, FRCPC
Phone:
1-514-412-4400
Email:
catherine.vezina.med@ssss.gouv.qc.ca
Investigator:
Last name:
Catherine Vezina, MD
Email:
Principal Investigator
Facility:
Name:
Chu De Quebec
Address:
City:
Quebec City
Zip:
G1V 4G2
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Bruno Michon, MD
Phone:
1-418-654-2158
Email:
bruno.michon.med@ssss.gouv.qc.ca
Investigator:
Last name:
Bruno Michon, MD
Email:
Principal Investigator
Start date:
November 3, 2023
Completion date:
December 2033
Lead sponsor:
Agency:
Tanja Andrea Gruber
Agency class:
Other
Collaborator:
Agency:
Pediatric Oncology Experimental Therapeutics Investigators' Consortium
Agency class:
Other
Collaborator:
Agency:
Amgen
Agency class:
Industry
Collaborator:
Agency:
Lucile Packard Foundation for Children's Health
Agency class:
Other
Collaborator:
Agency:
Kura Oncology, Inc.
Agency class:
Industry
Source:
Stanford University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05848687
