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Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

NCT02544438 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-09-27

No results posted yet for this study

Summary

A Phase I/IIa, open-label, uncontrolled study to evaluate the safety and efficacy of Astarabine (BST-236) as single agent in patients with refractory or relapsed Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) disease

Conditions

Interventions

DRUG

Astarabine (BST-236)

Cohort # Astarabine Dose Number of Patients 1. 0.5 gr/m2 (0.3 age\>50) 3 2. 1.5 gr/m2(0.8age\>50) 3 3. 3.0 gr/m2(1.5 age\>50) 3 4. 4.5 gr/m2(2.3 age\>50) 6 5. 4.5 gr/m2 (no age limit) 3 up to 6 6. 6 gr/m2 (no age limit) 3 up to 6 Total number of patients: up to 24

Sponsors & Collaborators

  • BioSight Ltd.

    lead INDUSTRY

Principal Investigators

  • Tsila Zuckerman, MD · Rambam Health Care Campus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-09-20
Completion
2017-09-20

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02544438 on ClinicalTrials.gov