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Report for Clinical Trial NCT03595917

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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)

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

NCT03595917 B-cell Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia (CML) in Lymphoid Blast Crisis Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph+ ALL
MeSH:Leukemia Leukemia, Myeloid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Blast Crisis Philadelphia Chromosome
HPO:Chronic myelogenous leukemia Leukemia Lymphoid leukemia Myeloid leukemia

3 Interventions

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 ---



HPO Nodes


HPO: