A Phase I Study of Oral ABL001 in Patients With CML or Ph+ ALL

Status: Recruiting
Phase: Phase 1
Diagnosis: Leukemia/MDS
NCT ID: NCT02081378 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-117


The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in CML and Ph+ ALL patients who are relapsed or refractory to or are intolerant of TKIs, and of ABL001+Nilotinib in Ph positive CML patients who are relapsed or refractory to TKIs.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Daniel DeAngelo, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org

Eligibility Criteria

Inclusion Criteria: Patients with Philadelphia chromosome-positive CML in chronic or accelerated phase who were previously treated with two different TKIs prior to study entry and are relapsed, refractory to or intolerant of TKIs as determined by investigators. Patients with Ph+ ALL must have a cytopathologically confirmed diagnosis of Ph+ ALL and be relapsed or refractory to one prior TKI or intolerant of TKIs. TKI failure for Ph+ ALL patients is defined as at least the loss of Molecular Response (MR) 4.5 (BCR-ABL ≤ 0.0032%). Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 Exclusion Criteria: - Systemic antineoplastic therapy (including alfa-interferon, unconjugated therapeutic antibodies and toxin immunoconjugates) or any experimental therapy within 14 days or 5 half-lives, whichever is longer, before the first dose of ABL001. Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of ABL001. CNS irradiation for meningeal leukemia, except if radiotherapy occurred > 3 months previously. Other protocol-defined inclusion/exclusion criteria may apply
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