Oshadi D & Oshadi R Combined With Salvage Chemotherapy for Relapsed Acute Myeloid Leukemia or Lymphoid Leukemia Patients

A Phase II, Open-Label, Single- Center Study to Assess the Activity of Oshadi D and Oshadi R in Combination With Salvage Chemotherapy for Relapsed or Refractory Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) Patients

The study will be a prospective open-label single-center study in previously treated patients with Acute Myeloid Leukemia (AML) or Acute Lymphoid Leukemia (ALL). Treatment efficacy and safety of the combination of Oshadi D (DNase in Oshadi carrier) and Oshadi R (RNase in Oshadi carrier) with Salvage Chemotherapy will be evaluated. Oshadi D and Oshadi R were shown to have anti-tumor activity and good safety profile.

Patients will receive Oshadi D and Oshadi R oral treatment combined with salvage chemotherapy. Patient will be evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D and Oshadi R.

Efficacy will be determined by percentage of bone marrow blasts assessment at day 28 post therapy initiation.

Study Overview

• Status: Suspended
• Conditions: Acute Myeloid Leukemia; Lymphoid Leukemia
• Intervention / Treatment: Drug: Oshadi D & Oshadi R;; Drug: salvage therapy cytosar and mitoxantrone

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients is diagnosed as AML or ALL
• Relapse defined as the presence of disease after the achievement of complete remission(CR). Refractory disease is defined as progression from or no response while treated with a previous line chemotherapy regimen, or progression within 30 days of last bone marrow assessment.
• Male or female ≥ 18 years of age
• Minimal performance status (ECOG 0, ≤2)
• Patients must have a measurable disease by bone marrow blast counts of > 5 % of nucleated cells.
• Written informed consent
• Adequate hepatic function (LFTs up to X4 the normal limits), renal function calculated Creatinine clearance (CrCl) for Adverse Effects of >30)
• Ability to swallow the medications.
• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.

Exclusion Criteria:

• Active infectious disease uncontrolled by antibiotics.
• Partially treated induction patients (i.e. day 14 non responding patients).
• Inability to receive high dose salvage chemotherapy.
• Patient with known positive HIV serology at screening.
• Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
• Evidence of ongoing cardiac dysrhythmias of NCI Common Toxicity Criteria for Adverse Effects (CTCAE ) Version 3.0 grade 2.
• Pre-existing mal absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
• Mental disorders.
• Inability to give written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 'Oshadi D & Oshadi R; salvage therapy'; Oshadi D (180mg/tid) & Oshadi R (180mg/tid) will be administrated orally; Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days) will be administrated	Drug: Oshadi D & Oshadi R; Oshadi D (180mg/TID) & Oshadi R (180mg TID) will be administrated; Other Names: Anti cancer agents; Drug: salvage therapy cytosar and mitoxantrone; Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days); Other Names: anti cancer agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation.	Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	28 days

Collaborators and Investigators

• Sponsor: Oshadi Drug Administration
• Investigators: Principal Investigator: Moshe Gatt, MD, Hadassah Medical Center, Jrusalem, Israel

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ANTICIPATED): June 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (ESTIMATE): June 4, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Lymphoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Mitoxantrone; Antineoplastic Agents
• Other Study ID Numbers: OS-AM-P2-01 Version 0.1