Actively Recruiting
A Phase 1 Study of ABL001 With Dasatinib, Prednisone, and Blinatumomab in BCR-ABL Positive B-cell Acute Lymphoblastic Leukemia and Chronic Myeloid Leukemia
Led by Marlise Luskin, MD · Updated on 2025-11-04
40
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Marlise Luskin, MD
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a drug called ABL001 combined with dasatinib (Sprycel4) and prednisone, along with blinatumomab, as a possible treatment for adults with B-cell Acute Lymphoblastic Leukemia that is BCR-ABL positive (also called Philadelphia chromosome positive Acute Lymphoblastic Leukemia) or Chronic Myeloid Leukemia in lymphoid blast crisis. This is a Phase I clinical trial aimed at testing the safety of ABL001 and determining the appropriate dose when used with these other drugs. Biomarker testing from blood and bone marrow samples will be included to better understand how the drug may work. Participants will receive all three drugs: ABL001 taken orally daily, dasatinib taken orally once a day per cycle, and prednisone taken orally once a day with tapering and stopping during the second cycle. Blinatumomab will be given by intravenous continuous infusion starting no earlier than the first day of cycle 2 through cycle 6, each cycle lasting 42 days, totaling five cycles. Dose escalation follows a standard scheme to find the recommended dose for future studies. During the study, participants will have blood and bone marrow samples collected to assess biomarkers and evaluate the cancer. Researchers will monitor safety and measure outcomes such as the maximum tolerated dose of ABL001 within 42 days and various remission and response rates at 28, 56, and 85 days. The study involves close monitoring of organ function and patient health throughout treatment, with the overall participation timeline depending on individual treatment cycles and responses.
CONDITIONS
Brief Title
ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed CD19+ BCR-ABL1+ acute leukemia or CML in lymphoid blast crisis with at least 5% lymphoblasts
- BCR-ABL1 positive status confirmed by FISH, karyotype, or molecular testing
- Participants aged 18 years and older
- Participants unsuitable for or unwilling to receive standard intensive induction chemotherapy (dose escalation group)
- Participants aged 18 years and older regardless of chemotherapy suitability (dose expansion group)
- Participants with relapsed or refractory disease after at least one cycle of intensive chemotherapy
- ECOG performance status 0-3 (with discussion for status 3)
- Normal organ function within specified lab limits
- Ability and willingness to use effective contraception during and 30 days after treatment
- Ability to understand and sign informed consent and comply with study procedures
You will not qualify if you...
- Participants suitable and willing to receive standard intensive induction chemotherapy (dose escalation group only)
- Known ABL T315I mutation
- Prior treatment with dasatinib or ASCIMINIB
- Use of other chemotherapy or investigational agents within 2 weeks before study start (except specified exceptions)
- Significant gastrointestinal conditions affecting drug absorption
- History of other malignancies requiring current treatment unless low risk
- Acute or chronic liver disease including active hepatitis B or C
- History of pulmonary arterial hypertension or significant pleural effusions
- Alcohol abuse requiring medical treatment
- History of pancreatitis or ongoing pancreatic disease
- Known HIV infection
- Serious bleeding disorders unrelated to leukemia
- Use of medications that strongly interact with study drug without physician approval
- Prolonged QTc interval over 480 ms on ECG
- Major surgery within 2 weeks before starting study
- Uncontrolled infection or unstable cardiovascular conditions
- Psychiatric or social situations limiting compliance
- Current requirement for life support measures
- Pregnancy or nursing at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 weeks (6 cycles)
Participants receive daily oral doses of ABL001, dasatinib, and prednisone during 28-day cycles. Prednisone will be tapered and stopped during cycle 2. Starting no earlier than cycle 2 day 1, participants receive blinatumomab by continuous intravenous infusion for 28 days of each 42-day cycle, for a total of 5 cycles.
Daily oral medication and continuous infusion during cycles 2-6; visits aligned with treatment cycles
Trial Site Locations
Total: 4 locations
1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14203
Actively Recruiting
Research Team
M
Marlise R. Luskin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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