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Phase II Cont. IV of ON 01910.Na in MDS w/ Trisomy 8/Intermed-1, 2/High Risk

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00987584
First Posted: October 1, 2009
Last Update Posted: February 6, 2012
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.
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Peter L Greenberg, Stanford University
  Purpose

This study is under Molecular and Cellular Characterization of Myelodysplastic Syndromes (MDS) (eProtocol 15369). The purpose of this proposed study is to analyze existing samples taken from participants participating in a clinical trial evaluating the efficacy and safety of investigational agent ON 01910.Na (eProtocol 16214). This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.

This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.


Condition
Myelodysplastic Syndromes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Biologic Correlates Study for "A Phase 2 Single-Arm Study To Assess The Efficacy and Safety Of 48-Hour Continuous Intravenous Dosing Of ON 01910.Na Administered Once a Week for 3 Weeks of a 4-Week Cycle in Myelodysplastic Syndrome Patients With Trisomy 8 or Classified as Intermediate-2 or High Ris

Resource links provided by NLM:


Further study details as provided by Peter L Greenberg, Stanford University:

Biospecimen Retention:   Samples Without DNA
marrow and peripheral blood

Enrollment: 14
Study Start Date: June 2009
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of IPSS Intermediate or High risk MDS
Criteria

Inclusion Criteria:

  • Diagnosis of IPSS Intermediate or High risk MDS by bone marrow biopsy, marrow cytogenetics and blood counts, using FAB morphologic criteria
  • Eastern Cooperative Oncology (ECOG) performance status of 0-2
  • Adequate Liver Function, as evidenced by a serum bilirubin less or equal to 1.5 times the laboratory normal range (except for patients with a confirmed diagnosis of Gilberts Disease) or an ALT and AST 3 times the laboratory normal range
  • A serum creatinine concentration less or equal to 2mg/dl
  • Subjects must be equal or greater than 18 years of age at the time of obtaining informed consent
  • Written informed consent

Exclusion Criteria:

  • Prior history of leukemia or aplastic anemia
  • Prior history of bone marrow transplantation
  • Platelet count <100,000/mm^3

    *Prior malignancy (other than in situ cervical cancer, controlled prostate cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for greater or equal to 3 years before randomization

  • Active or uncontrolled infections
  • Unstable angina, congestive heart failure [NYHA>classII], uncontrolled hypertension [diastolic >100mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
  • Less than 4 weeks since receipt of any investigational product or device
  • Pregnant or breast feeding
  • Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
  • Previously enrolled in this study
  • Will not be available for follow-up assessments
  • Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00987584


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Peter L Greenberg
The Leukemia and Lymphoma Society
Investigators
Principal Investigator: Peter L Greenberg Stanford University
  More Information

Responsible Party: Peter L Greenberg, Professor Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT00987584     History of Changes
Other Study ID Numbers: HEMMDS0023
15469 ( Other Identifier: Stanford University )
First Submitted: September 24, 2009
First Posted: October 1, 2009
Last Update Posted: February 6, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Trisomy
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Aneuploidy
Chromosome Aberrations
Chromosome Duplication