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Report for Clinical Trial NCT03595917
 Developed by Shray Alag, 2020-2021.
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 ---