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ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML

NCT03595917 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-04

No results posted yet for this study

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 40-65 people will take part in this research study.

* ABL001
* Dasatinib (Sprycel®)
* Prednisone
* Blinatumomab

Conditions

Interventions

DRUG

ABL001

•ABL001 is administered daily per 28 day cycle

DRUG

Dasatinib

Fixed doses oral once a day per 28 day cycle

DRUG

Prednisone

Fixed doses oral once a day per 28 day cycle Prednisone will be tapered and stop during cycle 2.

DRUG

Blinatumomab

By intravenous continuous infusion beginning no earlier than cycle 2 day 1 of protocol therapy Day 1-28 of each 42-day cycle, cycles 2-6, total of 5 cycles

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Marlise Luskin, MD

    lead OTHER

Principal Investigators

  • Marlise R. Luskin, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2026-11-01
Completion
2027-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03595917 on ClinicalTrials.gov