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

Myelodysplastic Syndromes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00100152
• Other study ID #: 0752-013
• Secondary ID: 2004_097
• Status: Terminated
• Phase: Phase 1
• First received: December 23, 2004
• Last updated: May 25, 2015
• Start date: February 2005
• Est. completion date: October 2006

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: October 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphoblastic, Acute, T-cell
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Myelodysplastic Syndromes
• Myelogenous Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

Intervention

Drug:
• MK0752, (Notch Inhibitor)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.