Loading clinical trials...

Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia

A Pilot Study to Evaluate the Safety and Preliminary Evidence of a Therapeutic Effect of ODSH (2-0, 3-0, Desulfated Heparin) in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia

NCT01843634•Jazz Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is an open-label pilot study evaluating the safety and preliminary evidence of a therapeutic effect of ODSH (2-0, 3-0 desulfated heparin) in conjunction with standard induction and consolidation therapy for acute myeloid leukemia.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Newly diagnosed, previously untreated acute myeloid leukemia. Acute promyelocytic leukemia is excluded.
•No prior chemotherapy for acute myeloid leukemia; however, prior hydroxyurea to control white blood cell count is allowed.
•No prior chemotherapy or lenalinomide for treatment of myelodysplastic syndrome.
•Age: 18-70.
•ECOG Performance status 0-2
•Cardiac ejection fraction ≥ 50% (echocardiography or MUGA \[multigated acquisition\])
•Adequate hepatic and renal function (AST \[aminotransferase\], ALT \[alanine aminotransferase\], bilirubin and creatinine \< 2.5 x upper normal limit).
•Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria

•Patients with acute promyelocytic leukemia
•Patients with acute megakaryoblastic leukemia
•Patients with CNS (central nervous system) leukemia
•Presence of significant active infection or uncontrolled bleeding
•Any coexisting major illness or organ failure which contraindicates the dose-intensive chemotherapy regimen prescribed by this protocol
•Pre-existing liver disease that might impair ODSH clearance
•History of other active malignant disease within 5 years, other than cured basal cell carcinoma of the skin, cured in situ carcinoma of the cervix, or localized prostate cancer that has received definitive therapy. Such prostate cancer patients who are receiving hormonal therapy are eligible
•Use of recreational drugs or history of drug addiction, within the prior 6 months
•Known history of positive hepatitis B surface antigens or hepatitis C antibodies
•Known history of positive test for HIV (Human immunodeficiency virus) antibodies
+10 more criteria

Locations (1)

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Key Dates

Start Date

August 1, 2013

Primary Completion Date

April 1, 2015

Completion Date

April 1, 2015

Last Updated

November 10, 2021

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

ODSH

DRUG

Phase I Study of HC-7366 for Acute Myeloid Leukemia

NCT06285890

Acute Myeloid Leukemia

View study

RECRUITINGPHASE2

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

NCT06220162

Acute Myeloid Leukemia

View study

RECRUITINGPHASE1/PHASE2

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

NCT04065399

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes