NCT00100152

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2005

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2004

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.6 years

First QC Date

December 23, 2004

Last Update Submit

May 25, 2015

Conditions

Leukemia, Lymphoblastic, Acute, T-cellMyelogenous LeukemiaChronic Lymphocytic LeukemiaMyelodysplastic Syndromes

Keywords

Relapsed or refractory T-cell ALL acute lymphoblastic/leukemiaRelapsed/refractory T-cell acute Lymphoblastic/leukemiaAcute/chronic myelogenous leukemiaPoor-risk myelodysplasia

Interventions

MK0752, (Notch Inhibitor)DRUG

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, MyeloidLeukemia, Lymphocytic, Chronic, B-CellMyelodysplastic SyndromesRecurrenceLeukemiaLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

3-(4-((4-chlorophenyl)sulfonyl)-4-(2,5-difluorophenyl)cyclohexyl)propanoic acid

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBone Marrow DiseasesMyeloproliferative Disorders

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2004

First Posted

December 24, 2004

Study Start

February 1, 2005

Primary Completion

September 1, 2006

Study Completion

October 1, 2006

Last Updated

May 27, 2015

Record last verified: 2015-05