TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Tanja Andrea Gruber
Study ID
NCT05848687
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
N/A - 1 Year
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Given orally (PO) or naso-gastrically (NG) or intravenously (IV).
  • Mitoxantrone — DRUG
    Given IV
  • PEG asparaginase — DRUG
    Given IV
  • Bortezomib — DRUG
    Given IV
  • Vorinostat — DRUG
    Taken PO or NG
  • Mercaptopurine — DRUG
    Given PO or NG.
  • Methotrexate — DRUG
    Given IV, IM or PO
  • Blinatumomab — DRUG
    Will be administered at 15 mcg/m2/day for 28 days following induction and reinduction
  • Ziftomenib — DRUG
    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

Study Details

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.

Key Dates

Start date
Nov 3, 2023
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2033

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance. Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib

Primary Outcome Measure

Minimal Residual Disease [ Time Frame: 5 years and 2 months ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016
Chris Oless, RN
[email protected]
602-933-0920
Dana Salzberg, MD (PRINCIPAL_INVESTIGATOR)
Arkansas Children's HospitalLittle RockArkansas72202
Kevin Bielamowicz, MD
[email protected]
501-364-4405
Kevin Bielamowicz, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital Los AngelesLos AngelesCalifornia90027
Deepa Bhojwani, MD
[email protected]
323-361-5922
Amber Medina
[email protected]
323-361-5654
Deepa Bhojwani, MD (PRINCIPAL_INVESTIGATOR)
Valley Children's HospitalMaderaCalifornia93636
Faisal Razzaqi, MD
[email protected]
559-353-3000
Faisal Razzaqi, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Orange CountyOrangeCalifornia92868
Jamie N Frediani, MD
[email protected]
714-509-8636
Dorian Chan
[email protected]
714-509-8646
Jamie N Frediani, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityPalo AltoCalifornia94304
Tanja A Gruber, MD, PhD
[email protected]
650 723 5535
Rady Children's Hospital San DiegoSan DiegoCalifornia92123
Deborah Schiff, MD
[email protected]
858-966-5811
Deborah Schiff, MD (PRINCIPAL_INVESTIGATOR)
Arnold Palmer Hospital for ChildrenOrlandoFlorida32806
Claudia Zapata, MD
[email protected]
321-841-8588
Marie Frankos
[email protected]
321-842-8738
Claudia P Zapata, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of MinnesotaMinneapolisMinnesota55404
Michael K Richards, MD, PhD
[email protected]
612-813-5940
Pauline Mitby
[email protected]
(612) 813-5913
Michael K Richards, MD, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Tanya Trippett, MD
[email protected]
212-639-8267
Tanya Trippett, MD (PRINCIPAL_INVESTIGATOR)
Novant Health - Hemby Children's HospitalCharlotteNorth Carolina28204
Christine Bolen, MD
[email protected]
704-384-1900
Christine Bolen, MD (PRINCIPAL_INVESTIGATOR)
Doernbecher Children's HospitalPortlandOregon97239
Bill Hoon Chang, Md, PhD
[email protected]
503-346-0640
Bill Hoon Chang, MD, PhD (PRINCIPAL_INVESTIGATOR)
Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-0850
Valerie Brown, MD,PhD
[email protected]
717-531-6012
Valerie Brown, Md, PhD (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas77030
David McCall, MD
[email protected]
717-792-6604
University of Texas Health Science Center San AntonioSan AntonioTexas78229
Jaclyn Hung Y Hung, PhD
[email protected]
210-567-7477
Anne-Marie Langevin, MD (PRINCIPAL_INVESTIGATOR)
University of Utah Huntsman Cancer InstituteSalt Lake CityUtah84108
David S Mangum, MD
[email protected]
801-662-4700
David Mangum, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of The King's DaughtersNorfolkVirginia23507
Eric Lowe, MD
[email protected]
757-668-7243
[email protected]
Eric Lowe, MD (PRINCIPAL_INVESTIGATOR)

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