Status:
TERMINATED
A Notch Signalling Pathway Inhibitor for Patients With T-cell Acute Lymphoblastic Leukemia/Lymphoma (ALL)(0752-013)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Leukemia, Lymphoblastic, Acute, T-cell
Myelogenous Leukemia
Eligibility:
All Genders
12+ years
Phase:
PHASE1
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00100152
Start Date
February 1 2005
End Date
October 1 2006
Last Update
May 27 2015
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