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

NCT02462265 | Suspended Phase 2 DMC

• 1 other identifier: OS-AM-P2-01 Version 0.1
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Myeloid Leukemia; Lymphoid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  28 days

Study Arms (1)

'Oshadi D & Oshadi R; salvage therapy'

EXPERIMENTAL

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;; Drug: salvage therapy cytosar and mitoxantrone

Interventions

Oshadi D & Oshadi R; DRUG

Oshadi D (180mg/TID) \& Oshadi R (180mg TID) will be administrated;

Also known as: Anti cancer agents

'Oshadi D & Oshadi R; salvage therapy'

salvage therapy cytosar and mitoxantrone DRUG

Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days)

Also known as: anti cancer agents

'Oshadi D & Oshadi R; salvage therapy'

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oshadi Drug Administration: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Lymphoid

Interventions

Antineoplastic Agents; Mitoxantrone

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds

Study Officials

• Moshe Gatt, MD

  Hadassah Medical Center, Jrusalem, Israel

  PRINCIPAL INVESTIGATOR

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: May 26, 2015
• First Posted: June 4, 2015
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04