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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:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Peter L Greenberg, Stanford University
ClinicalTrials.gov Identifier:
NCT00987584
First received: September 24, 2009
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Peter L Greenberg, Professor Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT00987584     History of Changes
Other Study ID Numbers: HEMMDS0023, 15469
Study First Received: September 24, 2009
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013