Safety and Efficacy Study of AS101 to Treat Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients

NCT01010373 | Suspended Phase 2

• 1 other identifier: #77REV00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether addition of AS101 to the standard chemotherapy regimen is effective in the treatment of newly diagnosed elderly (≥60) AML patients and AML transformed myelodysplastic syndrome (MDS) patients.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome

Keywords

Primary Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) induced AML.

Outcome Measures

Primary Outcomes (1)

• Time (days) to reach platelet counts ≥20,000/µl after first induction course and post-remission chemotherapy courses.

  Continously during study and maximum 6 months from the beginning of the study.

Secondary Outcomes (8)

• To assess safety and tolerability of AS101.

  Continously during study and maximum 6 months from the beginning of the study.

• Reduction in bone marrow blasts from baseline throughout the study period.

  Continously during study and maximum 6 months from the beginning of the study.

• Time (days) to reach platelets counts ≥50,000/µl after first induction course and subsequent post-remission chemotherapy courses.

  Continously during study and maximum 6 months from the beginning of the study.

• Time (days) to reach platelets counts ≥100,000/µl after first induction course and subsequent post-remission chemotherapy courses.

  Continously during study and maximum 6 months from the beginning of the study.

• Time (days) to reach the maximum platelets counts after chemotherapy courses throughout the study period.

  Continously during study and maximum 6 months from the beginning of the study.

Study Arms (1)

AS101 infusions

EXPERIMENTAL

In addition to induction chemotherapy AS101 will be given intravenously. The patient will also receive AS101 infusions during the time break till the next chemotherapy course, as long as the patient does not achieve complete remission and the platelet count is \<20,000/μl; ANC \<1000. AS101 will be administered likewise up to two consolidation or equivalent chemotherapy courses (re-induction or salvage in the event that no CR is achieved following first induction chemotherapy), i.e., total of three chemotherapy courses.

Drug: AS101

Interventions

AS101 DRUG

3 mg/m2 AS101 will be given intravenously (IV) three times per week.

AS101 infusions

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of primary AML or AML transformed myelodysplastic syndrome (MDS) with FAB classification other than M3 as proven by bone marrow aspiration.
• Age ≥60 years.
• ECOG performance status of 0-2 (Karnofsky \>60%).
• Adequate renal functions: Serum Creatinine \< 2 times the upper limit of normal (ULN).
• Adequate hepatic function: serum AST and ALT ≤ 3 x ULN.
• Patients with reproductive potential must use an effective contraceptive method through the study. Patients must receive contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.

You may not qualify if:

• Patients receiving any other investigational agents.
• Symptomatic CNS involvement.
• History of pancreatitis or active alcohol abuse.
• Histologic diagnosis of FAB M3 AML.
• Life expectancy of less than 1 month.
• Patient receives Myelotarg (ozogamicin gemtuzumab).
• Use of hematopoietic growth factors such as G-CSF within 1 week prior to treatment initiation.
• Pregnant or lactating females.
• Patient has known human immunodeficiency virus (HIV) infection or known HIV-related malignancy; Patient has active hepatitis A, B or C infection.
• Active, uncontrolled, systemic infection considered opportunistic, life threatening, or of clinical significance at the time of treatment, or any severe concurrent disease which, in the opinion of the investigator, would make the patient inappropriate for trial entry.
• The patient has had congestive heart failure - New York Heart Association (CHF-NYHA) grade II or higher, and/or myocardial infarction within the last 12 months, or any cardiac disorder which, in the opinion of the Investigator, could put the patient at risk of clinically relevant arrhythmia.

Sponsors & Collaborators

• BioMAS Ltd: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

ammonium trichloro(dioxoethylene-O,O'-)tellurate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 10, 2009
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

IL (1)