Clinical Trials /

Omacetaxine for Consolidation and Maintenance

NCT01873495

Description:

The purpose of this pilot study is to assess the safety and tolerability of omacetaxine for consolidation in patients age 55 and older with acute myelogenous leukemia (AML) in first complete remission following induction with cytarabine and an anthracycline, and also to assess the safety and tolerability of omacetaxine for maintenance in patients age 55 and older with acute AML in first complete remission following 3 consolidation courses with omacetaxine.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Omacetaxine for Consolidation and Maintenance
  • Official Title: Omacetaxine for Consolidation and Maintenance in Patients Age ≥ 55 With AML in First Remission: A Pilot Study

Clinical Trial IDs

  • ORG STUDY ID: IRB00057844
  • SECONDARY ID: Winship2176-11
  • NCT ID: NCT01873495

Conditions

  • Acute Myelogenous Leukemia (AML)

Interventions

DrugSynonymsArms
OmacetaxineSynriboOmacetaxine: Consolidation/Maintenance

Purpose

The purpose of this pilot study is to assess the safety and tolerability of omacetaxine for consolidation in patients age 55 and older with acute myelogenous leukemia (AML) in first complete remission following induction with cytarabine and an anthracycline, and also to assess the safety and tolerability of omacetaxine for maintenance in patients age 55 and older with acute AML in first complete remission following 3 consolidation courses with omacetaxine.

Trial Arms

NameTypeDescriptionInterventions
Omacetaxine: Consolidation/MaintenanceExperimental
  • Omacetaxine

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosis of AML including de novo, secondary, or with an antecedent hematologic
             disorder (AHD) according to the World Health Organization (WHO) criteria.

          2. Age ≥ 55 years.

          3. Patient eligible for standard induction chemotherapy based on Eastern Cooperative
             Oncology Group (ECOG) performance status and vital organ function at the discretion of
             the treating physician.

          4. Patients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine)
             are eligible.

          5. Provide signed written informed consent.

          6. Be able to comply with study procedures and follow-up examinations.

          7. Be non-fertile or agree to use birth control during the study through the end of last
             treatment visit.

          8. Adequate renal and hepatic function at the time of second registration:

               -  Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); and

               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN;
                  and

               -  Serum creatinine ≤ 1.2 x ULN.

          9. ECOG performance ≤ 2 at the time of second registration.

         10. Patients with a history of carcinoma in remission, on no therapy or on hormonal
             therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma are
             included in the study.

        Exclusion Criteria:

          1. Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB]
             classification M3 or WHO classification of APL with t (15;17)(q22;q12), (PML/retinoic
             acid receptor alpha [RARa] and variants).

          2. Prior treatment with omacetaxine.

          3. Relapsed or refractory AML.

          4. Investigational agent received within 30 days prior to the first dose of study drug.
             If received any investigational agent prior to this time point, drug-related
             toxicities must have recovered to Grade 2 or less prior to first dose of study drug.

          5. Psychiatric disorders that would interfere with consent, study participation, or
             follow-up.

          6. Systemic fungal, bacterial, viral, or other infection not controlled (defined as
             exhibiting ongoing signs/symptoms related to the infection and without improvement,
             despite appropriate antibiotics or other treatment).

          7. Any other severe concurrent disease, or have a history of serious organ dysfunction or
             disease involving the heart, kidney, liver, or other organ system that may place the
             patient at undue risk to undergo the proposed therapy. This includes uncontrolled
             hypertension and uncontrolled diabetes, as cases of life threatening hyperglycemia
             have been reported (using continuous infusion at higher doses of omacetaxine).

          8. Active carcinoma requiring systemic chemotherapy or radiation therapy.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:55 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease status will be assessed by a bone marrow aspirate and biopsy prior to each of 3 consolidation cycles (to ensure that patients are still in remission).
Time Frame:14 days
Safety Issue:
Description:Bone marrow biopsy and aspirate will be obtained.

Secondary Outcome Measures

Measure:Toxicities will be monitored by history, physical examination, and laboratory monitoring-during consolidation.
Time Frame:12 weeks
Safety Issue:
Description:Toxicities will be monitored by history, physical examination, and laboratory monitoring (CBC, serum chemistries to include renal and liver function tests) obtained weekly during consolidation and monthly during maintenance according to standard of care (Appendices C and D). Toxicity will be assessed according to the NCI Common Toxicity Criteria Version 4.0 (available at the NCI web site http://ctep.cancer.gov/reporting/ctc.html).

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Emory University

Last Updated