ABL001 + Dasatinib + Prednisone 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 : October 18, 2019
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 25-34 people will take part in this research study.
- Dasatinib (Sprycel®)
|Condition or disease||Intervention/treatment||Phase|
|B-cell Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia (CML) in Lymphoid Blast Crisis Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph+ ALL||Drug: ABL001 Drug: Dasatinib Drug: Prednisone||Phase 1|
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 and dasatinib are both 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of ABL001 in Combination With Dasatinib and Prednisone in Patients With BCR-ABL Positive (BCR-ABL+) B-cell Acute Lymphoblastic Leukemia (B-ALL) and Chronic Myeloid Leukemia (CML)|
|Actual Study Start Date :||July 24, 2018|
|Estimated Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||November 1, 2024|
Experimental: ABL001, Dasatinib, Prednisone
- Dose escalation will occur conventional Fibonocci 3+3 dose escalation scheme to determine a recommended phase 2 dose (RP2D)
•ABL001 is administered daily per 28 day cycle
Fixed doses oral once a day per 28 day cycle
Other Name: Sprycel
Fixed doses oral once a day per 28 day cycle Prednisone will be tapered and stop during cycle 2.
- 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.
- Percentage for Participants Achieving Hematologic Remission [ Time Frame: 28 Days ]
- Percentage for Participants Achieving Hematologic Remission [ Time Frame: 56 Days ]
- Percentage for Participants Achieving Hematologic Remission [ Time Frame: 85 Days ]
- Percentage of participants achieving cytogenetic response [ Time Frame: 28 Days ]
- Percentage of participants achieving cytogenetic response [ Time Frame: 56 Days ]
- Percentage of participants achieving cytogenetic response [ Time Frame: 85 Days ]
- Percentage of participants achieving a minimal residual disease (MRD)-negative CR by flow cytometry [ Time Frame: 85 Days ]
- Percentage of participants achieving a minimal residual disease (MRD)-negative CR by flow cytometry [ Time Frame: 28 Days ]
- Percentage of participants achieving a minimal residual disease (MRD)-negative CR by flow cytometry [ Time Frame: 56 Days ]
- Percentage of participants achieving molecular response [ Time Frame: 28 Days ]
- Percentage of participants achieving molecular response [ Time Frame: 56 Days ]
- Percentage of participants achieving molecular response [ Time Frame: 85 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595917
|Contact: Marlise R. Luskin, MD||617-632-1906||Marlise_Luskin@DFCI.HARVARD.edu|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Marlise R Luskin, MD|
|Contact: Jeremy Stewart 617-582-8063 email@example.com|
|Principal Investigator: Marlise Luskin, MD|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02214|
|Contact: Christine Connolly CCONNOLLY1@mgh.harvard.edu|
|Principal Investigator: Hanno Hock, MD|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Meredith Nutter, RN firstname.lastname@example.org|
|Principal Investigator: Malgorzata McMasters, MD|
|Principal Investigator:||Marlise R. Luskin, MD||Dana-Farber Cancer Institute|