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

NCT00987584 | Completed DMC

• 2 other identifiers: IRB-15469HEMMDS0023
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• Hematologic responses

  Marrow blast decrement

  4 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosis of IPSS Intermediate or High risk MDS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter L Greenberg: lead
• The Leukemia and Lymphoma Society: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

marrow and peripheral blood

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Peter L Greenberg

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: October 1, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

US (1)