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Trial record 1 of 1 for:    NCT02828878
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Prevention of Acute Graft Versus Host Disease in Patients Undergoing Allogeneic ApoGraft Stem Cell Transplantation

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Cellect Biotechnology
Sponsor:
Information provided by (Responsible Party):
Cellect Biotechnology
ClinicalTrials.gov Identifier:
NCT02828878
First received: July 4, 2016
Last updated: January 8, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Hematological Malignancies Biological: Allogeneic MPBC transplantation from matched related donor Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase I/II, Pilot, Staggered Four-Cohort Safety and Proof-of-Concept Study of ApoGraft in the Prevention of Acute Graft Versus Host Disease (aGvHD))

Resource links provided by NLM:


Further study details as provided by Cellect Biotechnology:

Primary Outcome Measures:
  • Overall incidence, frequency and severity of adverse events (AEs), potentially related to the product during the study. [ Time Frame: 100 days from transplantation ]

Secondary Outcome Measures:
  • Determination of the maximum tolerated dose of ApoGraft in subjects undergoing allogeneic bone marrow transplantation. [ Time Frame: 180 days from transplantation ]
  • Determination of the dose limiting toxicity of ApoGraft in subjects undergoing allogeneic bone marrow transplantation. [ Time Frame: 180 days from transplantation ]
  • Time of engraftment of neutrophils determined by number of days for reaching first of 3 consecutive days with ANC ≥ 500/mm3 without G-CSF support for 3 days. [ Time Frame: 28 days from transplantation ]
  • Rate of engraftment of neutrophils determined by number of days for reaching first of 3 consecutive days with ANC ≥ 500/mm3 without G-CSF support for 3 days. [ Time Frame: 28 days from transplantation ]
  • Time of engraftment of platelets 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. [ Time Frame: 40 days from transplantation ]
  • Rate of engraftment of platelets 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. [ Time Frame: 40 days from transplantation ]
  • Time of engraftment of ApoGraft product determined by proportion of patients reaching ANC levels ≥ 500/mm3 and platelets ≥ 20,000/mm3 for 3 consecutive days without G-CSF support for 3 days and platelet administration for previous 7 days [ Time Frame: 40 days from transplantation ]
  • Rate of engraftment of ApoGraft product determined by proportion of patients reaching ANC levels ≥ 500/mm3 and platelets ≥ 20,000/mm3 for 3 consecutive days without G-CSF support for 3 days and platelet administration for previous 7 days [ Time Frame: 40 days from transplantation ]
  • Chimerism rate at day 28, 100 and 180. [ Time Frame: 180 days from transplantation ]
  • Incidence of aGvHD at day 100 and 180. [ Time Frame: 180 days from transplantation ]
  • Grade and stage of aGvHD according to NIH criteria 2005; current and maximal score at day 100 and 180. [ Time Frame: 180 days from transplantation ]
  • Time to development of aGVHD [ Time Frame: 180 days from transplantation ]
  • Incidence of cGVHD by day 180 [ Time Frame: 180 days from transplantation ]
  • Grade and stage of cGVHD according to NIH criteria 2005; current and maximal score at day 180. [ Time Frame: 180 days from transplantation ]
  • Time to development of cGVHD [ Time Frame: 180 days from transplantation ]
  • Transplant-related mortality on day 100 and 180. [ Time Frame: 180 days from transplantation ]
  • Proportion of patients with disease relapse at days 100 and 180. [ Time Frame: 180 days from transplantation ]
  • Proportion of patients with overall survival at days 28,100 and 180. [ Time Frame: 180 days from transplantation ]
  • Incidence of infections (bacterial, fungal and viral) during study follow-up. [ Time Frame: 180 days from transplantation ]

Estimated Enrollment: 12
Study Start Date: January 2017
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ApoGraft
Mobilized Peripheral Blood Cells (MPBC) treatment in four Cohorts differing by the escalating concentration of the apoptotic mediator Fas Ligand to which the transplant is exposed to during an incubation period, prior to transplantation, ranging from 10, 25, 50 and 100 ng/ml in the fourth cohort .
Biological: Allogeneic MPBC transplantation from matched related donor

Detailed Description:

ApoGraft product is a mobilized peripheral blood cell product of a matched Related donor, collected via apheresis, which is exposed to the apoptotic mediator Fas Ligand (CD95L) prior to transplantation.

The study is designed to address the aspects of engraftment and Prevention of Acute Graft versus Host Disease (aGvHD) rate and/or severity in 12 Patients

STUDY DESIGN:

open label, linear with four-cohorts each consisting of 3 patients.

The study consists of a screening phase (subject and donor clinical assessment and screening tests), transplantation of ApoGraft, and a follow-up period of 180 days during and after hospitalization.

Cohorts' differentiation is by the escalating concentration of the apoptotic mediator Fas Ligand to which the transplant is exposed during incubation prior to transplantation, ranging from 10 ng/ml in the first cohort to 100 ng/ml in the fourth cohort.

The study will progress from one cohort to the next based on a DSMB analysis of the safety data.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult male or female subjects, 18-70 years of age.
  2. Subjects are eligible for allogeneic HLA-matched related HSCT for any hematological malignancies for which transplantation is appropriate with corresponding related donor.
  3. The donor and recipient must have full match at the HLA A, B, C, DR and DQ loci.
  4. Life expectancy of at least 6 months at the time of the baseline visit.
  5. ECOG performance status score 0-1 at time of the screening visit.
  6. Cardiac left ventricular ejection fraction ≥ 40% in adults within 4 weeks of initiation of conditioning.
  7. Pulmonary function test with DLCO, FEV1 and FVC of ≥ 50%.
  8. Oxygen saturation ≥ 90% on room air.
  9. Subjects must have adequate organ function as defined below:

    • AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal (ULN).
    • Serum creatinine <2.5 mg/dL.
    • Serum bilirubin <3 mg/dL.
  10. Signed written informed consent to participate in the study independently by subject. Subjects requiring a guardian to sign informed consent will not be included.
  11. Donor criteria according to standard WMDA criteria for donor selection. Signed written informed consent by donor including consent for 2nd donation if ApoGraft fails.
  12. Ability to comply with the requirements of the study.
  13. If female of childbearing potential, agree to use an acceptable method of birth control or be surgically sterile, and have a negative pregnancy test.

Exclusion Criteria:

  1. Participation in an investigational trial within 30 days of the screening visit.
  2. Progressive or poorly controlled malignancies.
  3. T-cell depleted allograft.
  4. Use of non-myeloabletive conditioning.
  5. Uncontrolled infections including sepsis, pneumonia with hypoxemia, persistent bacteremia, or meningitis within two weeks of the screening visit.
  6. Current known acute or chronic infection with HBV or HCV.
  7. Known human immunodeficiency virus (HIV) infection or AIDS.
  8. Subjects with severe or symptomatic restrictive or obstructive lung disease or respiratory failure requiring ventilator support.
  9. 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.
  10. 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.
  11. Organ allograft or previous history of allogeneic stem cell transplantation.
  12. Pregnancy or lactation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02828878

Contacts
Contact: Shai Yarkoni, MD, PhD 972-9-9741444 shai@cellectbio.com

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel
Principal Investigator: Tsila Zuckerman, MD         
Sponsors and Collaborators
Cellect Biotechnology
Investigators
Principal Investigator: Tsila Zuckerman, MD Rambam Hospital, Haifa, Israel
  More Information

Responsible Party: Cellect Biotechnology
ClinicalTrials.gov Identifier: NCT02828878     History of Changes
Other Study ID Numbers: ApoGraft 01
Study First Received: July 4, 2016
Last Updated: January 8, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Cellect Biotechnology:
Apoptosis
FAS Ligand
Bone marrow transplantation
GvHD
Stem cells

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on July 21, 2017