OncoMatch/Clinical Trials/NCT03595917
ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
Is NCT03595917 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including ABL001 and Dasatinib for b-cell acute lymphoblastic leukemia.
Treatment: ABL001 · Dasatinib · Prednisone · Blinatumomab — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Acute Lymphoblastic Leukemia
Chronic Myeloid Leukemia
Biomarker criteria
Required: CD19 overexpression
cytopathologically confirmed CD19+ BCR-ABL1+ acute leukemia
Required: BCR fusion
BCR-ABL1 positive status may be confirmed by FISH, karyotype analysis, or molecular testing for p210 (b2a2 or b3a2) or p190 (e1a2) transcripts
Excluded: ABL1 T315I
Patients with a known ABL T315I mutation are excluded
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: bcr-abl inhibitor (dasatinib, asciminib)
Lab requirements
Kidney function
Creatinine ≤ 1.5x institutional upper limit of normal.
Liver function
Amylase and lipase values ≤ 3.0x institutional upper limit of normal. Alkaline phosphatase ≤ 2.5x institutional upper limit of normal (unless considered to be not of hepatic origin) (any level permitted), and/or unless felt to be clearly related to disease where ≤ 5x institutional upper limit of normal is permitted, after discussion with the overall PI. AST(SGOT)/ALT(SGPT) ≤ 3x institutional upper limit of normal unless felt to be clearly related to disease where ≤ 5x institutional upper limit of normal is permitted, after discussion with the overall PI. Total bilirubin - ≤1.5x institutional upper limit of normal (≤ 3x upper limit of normal in patients with known or suspected Gilbert's syndrome).
Participants must have normal organ function as defined below: Creatinine ≤ 1.5x institutional upper limit of normal. Amylase and lipase values ≤ 3.0x institutional upper limit of normal. Alkaline phosphatase ≤ 2.5x institutional upper limit of normal (unless considered to be not of hepatic origin) (any level permitted), and/or unless felt to be clearly related to disease where ≤ 5x institutional upper limit of normal is permitted, after discussion with the overall PI. AST(SGOT)/ALT(SGPT) ≤ 3x institutional upper limit of normal unless felt to be clearly related to disease where ≤ 5x institutional upper limit of normal is permitted, after discussion with the overall PI. Total bilirubin - ≤1.5x institutional upper limit of normal (≤ 3x upper limit of normal in patients with known or suspected Gilbert's syndrome).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Chicago Comprehensive Cancer Center · Chicago, Illinois
- Dana Farber Cancer Institute · Boston, Massachusetts
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
- Roswell Park Comprehensive Cancer Center · Buffalo, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03595917 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior bcr-abl inhibitor disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 overexpression is a required biomarker for enrollment.
Does this trial require BCR?
Yes, BCR fusion is a required biomarker for enrollment.
Are patients with ABL1 alterations eligible?
No. ABL1 T315I is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify