Prevention of Acute Graft Versus Host Disease in Patients Undergoing Allogeneic ApoGraft Stem Cell Transplantation

NCT02828878 | Unknown Phase 1 DMC

• 1 other identifier: ApoGraft 01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

Interventional, open label, Phase I/II, Safety and Proof-of-Concept Study, with a follow up period of 180 days after the transplantation of ApoGraft.

Conditions

Hematological Malignancies

Keywords

Apoptosis; FAS Ligand; Bone marrow transplantation; GvHD; Stem cells

Outcome Measures

Primary Outcomes (1)

• Overall incidence, frequency and severity of adverse events (AEs) potentially related to the product during the study

  180 days from transplantation

Secondary Outcomes (10)

• Determination of the optimal dose of FasL concentration that facilitates the biological activity of the ApoGraft process

  180 days from transplantation

• Time of neutrophils engraftment determined by number of days for reaching first of 3 consecutive days with ANC ≥ 500/mm3

  28 days from transplantation

• Rate of neutrophils engraftment determined by number of days for reaching first of 3 consecutive days with ANC ≥ 500/mm3

  28 days from transplantation

• Time of platelets engraftment determined by number of days for reaching first of 3 consecutive days with platelets ≥ 20,000/mm3 in the absence of platelet administration during the prior 7 days

  180 days from transplantation

• Rate of platelets engraftment determined by number of days for reaching first of 3 consecutive days with platelets ≥ 20,000/mm3 in the absence of platelet administration during the prior 7 days

  180 days from transplantation

Study Arms (1)

ApoGraft

EXPERIMENTAL

ApoGraft is a mobilized peripheral blood cell (MPBC) product derived from peripheral blood. There will be 4 cohorts, each differ in the amount of apoptotic mediator Fas Ligand (APO010) to which the graft is exposed during incubation prior to ApoGraft transplant, ranging from 10 ng/ml APO010 in Cohort 1, 25 ng/ml APO010 in Cohort 2, 50 ng/ml APO010 in Cohort 3, and 100 ng/ml APO010 in Cohort 4

Biological: Allogeneic MPBC transplantation from matched related donor

Interventions

Allogeneic MPBC transplantation from matched related donor BIOLOGICAL

ApoGraft

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female subjects, 18-70 years of age.
• Subjects are eligible for allogeneic HLA-matched related HSCT for any hematological malignancies for which transplantation is appropriate with corresponding related donor. One of the following hemato-oncology disorders diagnosis is required:
• Acute myelogenous leukemia (AML) and Acute lymphoblastic leukemia (ALL) in 1st or subsequent complete remission (CR)
• Non-Hodgkin's disease (NHD) in CR by CT or PET/CT
• Hodgkin's disease (HD) in 1st or subsequent CR by CT or PET/CT
• Intermediate, High or Very High Risk Myelodysplastic syndrome (MDS) (IPSS-R criteria)
• The donor and recipient must have full match at the HLA A, B, C, DR and DQ loci.
• ECOG performance status score 0-1 at time of the screening visit.
• Subjects must have adequate organ function as defined in the study protocol
• Signed written informed consent to participate in the study.
• If female of childbearing potential, agree to use an acceptable method of birth control or be surgically sterile, and have a negative pregnancy test.
• Adult male or female subjects, 18-65 years of age.
• Donor criteria according to standard WMDA criteria for donor selection. 3 Must have full match at the HLA A, B, C, DR and DQ loci with the recipient.
• \. Signed written informed consent

You may not qualify if:

• Use of non-myeloabletive conditioning.
• Uncontrolled infections including sepsis, pneumonia with hypoxemia, persistent bacteremia, or meningitis within two weeks of the screening visit.
• Current known acute or chronic infection with HBV or HCV.
• Known human immunodeficiency virus (HIV) infection or AIDS.
• Subjects with severe or symptomatic restrictive or obstructive lung disease or respiratory failure requiring ventilator support.
• Subjects with other concurrent severe and/or uncontrolled medical condition, which could compromise participation in the study (i.e. active infection, uncontrolled diabetes, uncontrolled hypertension, congestive cardiac failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months and chronic liver or renal disease.
• Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder or any chronic condition susceptible, in the opinion of the investigator, of interfering with the conduct of the study.
• Organ allograft or previous history of allogeneic stem cell transplantation.
• Pregnancy or lactation.
• HIV, HBV or HCV positive subjects.
• Pregnant or lactating women.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Cellect Biotechnology: lead

Study Sites (2)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

Hadassah Medical Center, Ein Kerem, Jerusalem

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Autoimmune Lymphoproliferative Syndrome, Type IB

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Tsila Zuckerman, MD

  Rambam Hospital, Haifa, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shai Yarkoni, MD

CONTACT

972-9-9741444; shai@cellect.co

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: July 12, 2016
• Study Start: January 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)