Chronic Lymphocytic Leukemia, Leukemia, Lymphoblastic, Acute, T-cell, Myelodysplastic Syndromes, Myelogenous Leukemia
Conditions
Keywords
Relapsed or refractory T-cell ALL acute lymphoblastic/leukemia, Relapsed/refractory T-cell acute Lymphoblastic/leukemia, Acute/chronic myelogenous leukemia, Poor-risk myelodysplasia
Brief summary
A Notch signalling pathway inhibitor study in pediatric and adult patients with relapsed (worsening) or refractory (not responding to treatment) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL).
Interventions
DRUGMK0752, (Notch Inhibitor)
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have pathologically documented precursor T-cell acute lymphoblastic leukemia/lymphoma (T-ALL), relapsed or refractory to standard therapy, or not be a candidate for standard myelosuppressive chemotherapy due to age or comorbid disease. * Patient must have performance status \<2 on the ECOG performance status for patients \>16 years old; Lansky performance level \>50 for patients 12 months to less than or equal to 16 years old. * Patient must have adequate renal and liver function as indicated by the laboratory values performed within 14 days of receiving the first dose of study drug. * Patient must have fully recovered from any chemotherapy and be greater than 2 weeks from radiotherapy, immunotherapy, or systemic steroid therapy with the exception of hydroxyurea, intrathecal therapy, or immunosuppressant therapy for chronic graft-versus-host disease prophylaxis following allogeneic bone marrow transplant. * Patient must be greater than 2 months following bone marrow or peripheral blood stem cell transplantation and off all immunosuppressant therapy (with the exception of patients taking immunosuppressant therapy for chronic graft-versus-host disease prophylaxis following allogeneic bone marrow transplant). * Men and women of reproductive potential must use an effective contraceptive method while enrolled in the study. * Patient or the patient's legal representative must be able to understand the study and give written informed consent.
Exclusion criteria
* Patient has had treatment with any investigational therapy during the preceding 30 days. * Patient has uncontrolled congestive heart failure, angina, or had a myocardial infarction in the preceding 3 months. * Patient has known hypersensitivity to the components of study drug, its analogs, or to allopurinol. * Patient has active or uncontrolled infection. * Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Patient is pregnant or lactating. * Patient has any other severe concurrent disease which would make the patient inappropriate for entry into this study. * Patient is known to be HIV positive or who has an AIDS-related illness. * Patients with a currently active second malignancy, other than non-melanoma skin cancer should not be enrolled. * Patient has isolated CNS disease.
Outcome results
None listed