Clinical trial · Interventional
A Notch Signalling Pathway Inhibitor for Patients With T-cell Acute Lymphoblastic Leukemia/Lymphoma (ALL)(0752-013)
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
NCT00100152CI-TRIAL-00018028terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Leukemia, Lymphoblastic, Acute, T-cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myelogenous Leukemia | Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MK0752, (Notch Inhibitor) | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.