OncoMatch/Clinical Trials/NCT03595917
ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
Is NCT03595917 recruiting? Yes, currently enrolling (May 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
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
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