A Phase II Study of MK-0457 in Patients With BCR-ABL T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 272

Inclusion Criteria

Patient is male or female, and =18 years of age on day of signing informed consent; ECOG performance status as stated in the protocol; The interval from prior treatment (standard or investigational) to time of study drug administration should be at least 2 weeks for cytotoxic agents or at least 5 half-lives for non-cytotoxic agents. The only exception is hydroxyurea which can be used to control peripheral leukemic cell counts prior to initiating study drug and during the first treatment cycle. Persistent clinically significant chronic toxicities from prior chemotherapy must not be greater than Grade 2 (except alopecia); Patient must have proper organ function as outlined in the protocol; Patients under consideration for inclusion into this study must have Ph+ (or BCR-ABL+) CML or ALL and meet one of the following disease inclusion criteria; Patients with documented BCR-ABL T315I mutation;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient has not fully recovered from acute side effects of prior anti-leukemic therapy to = Grade 2 toxicity, except alopecia; Patient within 3 months of allogeneic bone marrow transplant and/or has active and uncontrolled Graft-versus-Host disease following allogeneic bone marrow transplant and/or not on a stable dose of immunosuppressants for at least one month; Patient has uncontrolled symptomatic congestive heart failure, angina, or had a myocardial infarction in the preceding 3 months; Patient has known hypersensitivity to the components of study drug or its analogs; Patient has uncontrolled active infection; Patient has a known psychiatric or substance abuse disorder that in the opinion of the Investigator would interfere with cooperation with the requirements of the trial; Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the study; Patient has any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study; Patients with currently active” second malignancy, other than non-melanoma skin cancer, should not be enrolled. Patients are not considered to have a currently active” malignancy if they have completed therapy for a prior malignancy and are considered by their treating physician to be at less than 30% risk of relapse; Patient is known to be HIV seropositive or who has an AIDS-related illness; Patient has known active hepatitis B or C (and/or treated previously with abnormal liver function tests); Patient has adequate cardiac function by multigated radionucleotide angiography (MUGA) or echocardiography.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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