SNPMiner Trials (Home Page)
Report for Clinical Trial NCT03595917
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
- ABL001
- Dasatinib (Sprycel®)
- Prednisone
Name: ABL001
Description: •ABL001 is administered daily per 28 day cycle
Type: Drug
Group Labels: 1 ABL001, Dasatinib, Prednisone
Name: Dasatinib
Description: Fixed doses oral once a day per 28 day cycle
Type: Drug
Group Labels: 1 ABL001, Dasatinib, Prednisone
Name: Prednisone
Description: Fixed doses oral once a day per 28 day cycle Prednisone will be tapered and stop during cycle 2.
Type: Drug
Group Labels: 1 ABL001, Dasatinib, Prednisone
Primary Outcomes
Description: 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.
Measure: Maximum tolerated dose (MTD) of ABL001
Time: 42 Days
Secondary Outcomes
Measure: Percentage for Participants Achieving Hematologic Remission Time: 28 Days
Measure: Percentage for Participants Achieving Hematologic Remission Time: 56 Days
Measure: Percentage for Participants Achieving Hematologic Remission Time: 85 Days
Measure: Percentage of participants achieving cytogenetic response Time: 28 Days
Measure: Percentage of participants achieving cytogenetic response Time: 56 Days
Measure: Percentage of participants achieving cytogenetic response Time: 85 Days
Measure: Percentage of participants achieving a minimal residual disease (MRD)-negative CR by flow cytometry Time: 85 Days
Measure: Percentage of participants achieving a minimal residual disease (MRD)-negative CR by flow cytometry Time: 28 Days
Measure: Percentage of participants achieving a minimal residual disease (MRD)-negative CR by flow cytometry Time: 56 Days
Measure: Percentage of participants achieving molecular response Time: 28 Days
Measure: Percentage of participants achieving molecular response Time: 56 Days
Measure: Percentage of participants achieving molecular response Time: 85 Days
Purpose: Treatment
Allocation: N/A
Single Group Assignment
There is one SNP
SNPs
1 T315I
- Patients with a known ABL T315I mutation are excluded. --- T315I ---