Clinical trial NCT00100152: A Notch Signalling Pathway Inhibitor for Patients With T-cell Acute Lymphoblastic Leukemia/Lymphoma (ALL)(0752-013)
Official title: A Phase I Study of a Gamma Secretase Inhibitor for Adult and Pediatric Patients With Relapsed or Refractory Acute T-Cell Lymphoblastic Leukemia and Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Leukemia, Lymphoblastic, Acute, T-cell
Myelogenous Leukemia
Chronic Lymphocytic Leukemia
Myelodysplastic Syndromes
Keywords: Relapsed or refractory T-cell ALL acute lymphoblastic/leukemia
Relapsed/refractory T-cell acute Lymphoblastic/leukemia
Acute/chronic myelogenous leukemia
Poor-risk myelodysplasia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-12-24
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: