ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Marlise Luskin, MD
Study ID
NCT03595917
Phase
PHASE1
Status
Recruiting
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Conditions

  • B-cell Acute Lymphoblastic Leukemia
  • Chronic Myeloid Leukemia (CML) in Lymphoid Blast Crisis
  • Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph+ ALL

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABL001 — DRUG
    •ABL001 is administered daily per 28 day cycle
  • Dasatinib — DRUG
    Fixed doses oral once a day per 28 day cycle
  • Prednisone — DRUG
    Fixed doses oral once a day per 28 day cycle Prednisone will be tapered and stop during cycle 2.
  • Blinatumomab — DRUG
    By intravenous continuous infusion beginning no earlier than cycle 2 day 1 of protocol therapy Day 1-28 of each 42-day cycle, cycles 2-6, total of 5 cycles

Study Details

This research study is evaluating a drug called ABL001 taken in combination with dasatinib (Sprycel®) and prednisone (a steroid) as a possible treatment for B-cell Acute Lymphoblastic Leukemia that is BCR-ABL positive (BCR-ABL+ B-ALL) or Chronic Myeloid Leukemia (CML) in lymphoid blast crisis. BCR-ABL+ B-ALL is also called Philadelphia chromosome positive Acute Lymphoblastic Leukemia (Ph+ ALL). It is expected that 40-65 people will take part in this research study. * ABL001 * Dasatinib (Sprycel®) * Prednisone * Blinatumomab

Key Dates

Start date
Jul 24, 2018
Status verified
Nov 2025
Primary completion
Nov 1, 2026
Completion
Nov 1, 2027

Study Design

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

Arms

  • Experimental: ABL001, Dasatinib, Prednisone, Blinatumomab
    \- Dose escalation will occur conventional Fibonocci 3+3 dose escalation scheme to determine a recommended phase 2 dose (RP2D) * Dasatinib-Fixed doses oral once a day per cycle * ABL001 is administered orally daily per cycle * Prednisone-Fixed doses oral once a day per cycle. \--- Prednisone will be tapered and stop during cycle 2. * Blinatumomab - intravenous continuous infusion beginning no earlier than cycle 2 day 1 * Blinatumomab - Day 1-28 of each 42-day cycle, cycles 2-6, total of 5 cycles

Primary Outcome Measure

Maximum tolerated dose (MTD) of ABL001 [ Time Frame: 42 Days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637
Wendy Stock, MD
855-702-8222
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jessica Liegel, MD
Dana Farber Cancer InstituteBostonMassachusetts02115
Marlise R Luskin, MD
Marlise Luskin, MD (PRINCIPAL_INVESTIGATOR)
Roswell Park Comprehensive Cancer CenterBuffaloNew York14203
Eunice Wang, MD
716-845-2300

Find similar trials in Chicago, IL

By research site
University of Chicago Comprehensive Cancer Center· Chicago, ILBeth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MARoswell Park Comprehensive Cancer Center· Buffalo, NY

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