RecruitingB-cell Acute Lymphoblastic LeukemiaChronic Myeloid Leukemia (CML) in Lymphoid Blast CrisisPhiladelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph+ ALL
ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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
Sponsor: Marlise Luskin, MD
You may qualify if…
- ✓ Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- ✓ Participants must have cytopathologically confirmed CD19+ BCR-ABL1+ acute leukemia (B-cell ALL, mixed phenotype acute leukemia, or CML in lymphoid blast crisis with ≥ 5% lymphoblasts.)22
- ✓ BCR-ABL1 positive status may be confirmed by FISH, karyotype analysis, or molecular testing for p210 (b2a2 or b3a2) or p190 (e1a2) transcripts.
- ✓ Patients with asymptomatic central nervous system (CNS) disease are eligible and may be treated concurrently with intrathecal chemotherapy.
- ✓ Dose escalation: Participants must NOT be suitable for or willing to receive standard intensive induction chemotherapy.
- ✓ Dose expansion: Participants aged 18 years and older will be eligible regardless of suitability for intensive induction chemotherapy.
- ✓ The following groups are not considered suitable for standard intensive induction chemotherapy:
- ✓ Participants who have not received standard intensive induction chemotherapy and are aged ≥ 50 years.
You may not qualify if…
- ✕ For dose escalation only: Participants suitable for and willing to receive standard intensive induction chemotherapy.
- ✕ Patients with a known ABL T315I mutation are excluded. ABL kinase mutation analysis is not recommended for newly diagnosed patient. ABL kinase mutation analysis is recommended for patients with relapsed disease or CML progressed to blast phase on prior TKI, and results should be reviewed prior to enrollment.
- ✕ Prior treatment of ALL or CML with dasatinib or ASCIMINIB. Prior receipt of other TKIs and chemotherapy for the treatment of ALL or CML is permitted.
- ✕ Any TKI therapy must be discontinued for 5 half-lives prior to initiation of protocol therapy.
- ✕ Patient may not have received other chemotherapy, including antibody-based therapy, within 2 weeks of the initiation of protocol therapy with the exception of steroids, hydroxyurea, ATRA, and/or intrathecal chemotherapy.
- ✕ Participants who are receiving any other investigational agents for conditions other than ALL must have discontinued those agents 2 weeks prior to the start of study treatment.
- ✕ Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome). Patients who have had a gastrectomy are not excluded.
- ✕ History of prior or concurrent malignancy requiring current treatment and/or whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Indolent or low risk cancers (i.e. early stage prostate cancer, early stage breast cancer, asymptomatic meningioma) judged to not require treatment and/or have low potential for progression/recurrence after appropriate therapy may be permitted after discussion with overall PI.
Where it's recruiting
Source: ClinicalTrials.gov · NCT03595917 · last updated 2025-11-04