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A Notch Signalling Pathway Inhibitor for Patients With T-cell Acute Lymphoblastic Leukemia/Lymphoma (ALL)(0752-013)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00100152
First received: December 23, 2004
Last updated: May 15, 2014
Last verified: May 2014

December 23, 2004
May 15, 2014
July 2005
October 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00100152 on ClinicalTrials.gov Archive Site
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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

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia, Lymphoblastic, Acute, T-cell
  • Myelogenous Leukemia
  • Chronic Lymphocytic Leukemia
  • Myelodysplastic Syndromes
Drug: MK0752, (Notch Inhibitor)
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
October 2006
October 2006   (final data collection date for primary outcome measure)

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.
Both
12 Months and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00100152
0752-013, 2004_097
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP