ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
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ClinicalTrials.gov Identifier: NCT03595917 |
Recruitment Status :
Recruiting
First Posted : July 23, 2018
Last Update Posted : December 5, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | July 12, 2018 | ||||
First Posted Date ICMJE | July 23, 2018 | ||||
Last Update Posted Date | December 5, 2023 | ||||
Actual Study Start Date ICMJE | July 24, 2018 | ||||
Estimated Primary Completion Date | November 1, 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Maximum tolerated dose (MTD) of ABL001 [ Time Frame: 42 Days ] To define the maximum tolerated dose (MTD) of ABL001 for participants with BCR-ABL positive (BCR-ABL+) B-cell acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML) in lymphoid blast crisis.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML | ||||
Official Title ICMJE | 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) | ||||
Brief 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 25-40 people will take part in this research study.
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: ABL001, Dasatinib, Prednisone, Blinatumomab
- Dose escalation will occur conventional Fibonocci 3+3 dose escalation scheme to determine a recommended phase 2 dose (RP2D)
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
40 | ||||
Original Estimated Enrollment ICMJE |
34 | ||||
Estimated Study Completion Date ICMJE | November 1, 2026 | ||||
Estimated Primary Completion Date | November 1, 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
The following groups are not considered suitable for standard intensive induction chemotherapy:
The effects of ASCIMINIB on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
Exclusion Criteria:
Screening for hepatitis is not required. Patients with known treated or past exposure viral hepatitis may participate after confirmation of absence of active infection (i.e. negative viral load).
As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
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Administrative Information | |||||
NCT Number ICMJE | NCT03595917 | ||||
Other Study ID Numbers ICMJE | 18-170 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Marlise Luskin, MD, Dana-Farber Cancer Institute | ||||
Original Responsible Party | Marlise R. Luskin, Dana-Farber Cancer Institute, Sponsor Investigator | ||||
Current Study Sponsor ICMJE | Marlise Luskin, MD | ||||
Original Study Sponsor ICMJE | Marlise R. Luskin | ||||
Collaborators ICMJE | Novartis | ||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||
Verification Date | December 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |