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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00100152
Recruitment Status : Terminated
First Posted : December 24, 2004
Last Update Posted : May 27, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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).

Condition or disease Intervention/treatment Phase
Leukemia, Lymphoblastic, Acute, T-cell Myelogenous Leukemia Chronic Lymphocytic Leukemia Myelodysplastic Syndromes Drug: MK0752, (Notch Inhibitor) Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : October 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00100152

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00100152    
Other Study ID Numbers: 0752-013
First Posted: December 24, 2004    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Merck Sharp & Dohme Corp.:
Relapsed or refractory T-cell ALL acute lymphoblastic/leukemia
Relapsed/refractory T-cell acute Lymphoblastic/leukemia
Acute/chronic myelogenous leukemia
Poor-risk myelodysplasia
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Leukemia, Lymphoid
Leukemia, B-Cell