NCT03595917

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

A Phase 1 Study of ABL001 in Combination With Dasatinib, Prednisone, and Blinatumomab in Patients With BCR-ABL Positive (BCR-ABL+) B-cell Acute Lymphoblastic Leukemia (B-ALL) and Chronic Myeloid Leukemia (CML)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Marlise Luskin, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. There is currently no clinical data on the effects of ABL001 in combination with dasatinib and prednisone among adults with Ph+ B-ALL or CML in lymphoid blast crisis. However, there is data on the use of ABL001 in combination with dasatinib (without steroids) in patients with relapsed Ph+ B-ALL and Ph+ chronic myeloid leukemia (CML). Dasatinib (Sprycel®) is currently approved for the treatment in newly diagnosed adults with Ph+ CML in chronic phase (CP), adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib, adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. ABL001 is a newly discovered compound. This drug has been used in laboratory experiments and information from those experiments suggest that this drug may have beneficial effects in people who have CML or Ph+ ALL, both of which are a certain type of cancer of the blood cells. The reason for this study is to learn whether ABL001 is safe and can have possible benefits for people with Ph+ ALL who are also being treated with dasatinib and prednisone, two drugs which are commonly used to treat Ph+ ALL. All participants in this study will receive all three drugs. Prednisone, dasatinib and blinatumomab are all FDA approved and standard of care for participants with your disease.They are not considered investigational on this study. However, ABL001 is being tested in combination with these drugs. Biomarker testing will also be included in this study. Biomarkers are important biological "indicators" of whether a drug is working which can be measured from bone marrow and blood samples. In addition, blood and bone marrow samples may be tested to try to learn more about the cancer, and to understand how the drug may be working in cancer.

Conditions

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

Interventions

Type	Name	Description
DRUG	ABL001	•ABL001 is administered daily per 28 day cycle
DRUG	Dasatinib	Fixed doses oral once a day per 28 day cycle
DRUG	Prednisone	Fixed doses oral once a day per 28 day cycle Prednisone will be tapered and stop during cycle 2.
DRUG	Blinatumomab	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

Timeline

• Start date: 2018-07-24
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2018-07-23
• Last updated: 2025-11-04

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study