A Notch Signalling Pathway Inhibitor for Patients With T-cell Acute Lymphoblastic Leukemia/Lymphoma (ALL)
This study has been terminated.
Information provided by:
First received: December 23, 2004
Last updated: January 21, 2010
Last verified: January 2010
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).
Leukemia, Lymphoblastic, Acute, T-Cell
Chronic Lymphocytic Leukemia
Drug: MK0752, (Notch Inhibitor)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2006 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||12 Months and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100152
No publications provided
||Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 23, 2004
||January 21, 2010
||United States: Food and Drug Administration
Keywords provided by Merck:
Relapsed or refractory T-cell ALL acute lymphoblastic/leukemia
Relapsed/refractory T-cell acute Lymphoblastic/leukemia
Acute/chronic myelogenous leukemia
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 18, 2013
Leukemia, Lymphocytic, Chronic, B-Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immune System Diseases
Bone Marrow Diseases