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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02462265
• Other study ID #: OS-AM-P2-01 Version 0.1
• Status: Suspended
• Phase: Phase 2
• First received: May 26, 2015
• Last updated: April 16, 2018
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: Oshadi Drug Administration
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 15
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoid Leukemia

Intervention

Drug:
• Oshadi D & Oshadi R;
Oshadi D (180mg/TID) & Oshadi R (180mg TID) will be administrated;
• salvage therapy cytosar and mitoxantrone
Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oshadi Drug Administration

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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