CClinicalTrials.gg
Status unknownNCT03260101Updated Nov 26, 2019

Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study

An observational study in Acute Myelogenous Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) and Non Hodgkin Lymphoma (NHL), sponsored by Cellect Biotechnology. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-11-26.

Sponsored by Cellect Biotechnology · Observational

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
12
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is a non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01. Up to 12 subjects who completed ApoGraft-01 study will be offered to participate in this follow-up study.

Subjects who completed ApoGraft-01 study and have signed informed consent for this follow-up study will be eligible to enroll. Subject will attend in-clinic visits up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (GvHD) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence), physical examination, safety laboratory and concomitant medication use.

02

Conditions studied

  • Acute Myelogenous Leukemia (AML)
  • Acute Lymphoblastic Leukemia (ALL)
  • Non Hodgkin Lymphoma (NHL)
  • Hodgkin Lymphoma, Adult
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Up to 12 subjects who completed ApoGraft-01 study will be offered to participate in this follow-up study. Subjects must have had one of the Hemato-Oncology Diseases to enroll into ApoGraft-01:

  • Acute myelogenous leukemia (AML) \& Acute lymphoblastic leukemia (ALL)
  • Non-Hodgkin's lymphoma (NHL)
  • Hodgkin's lymphoma (HL)
  • Intermediate, High or Very High risk Myelodysplastic syndrome (MDS)

Eligibility criteria

Inclusion Criteria:

  1. Subjects who completed study ApoGraft-01 through 180 days (6 months) post-transplantation
  2. Ability to comply with the requirements of the study.
  3. Signed written informed consent
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
12 participants (estimated)
Patient registry
No

Groups and cohorts

  • one group, ApoGraft Follow up Study

    Non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01

    Other: non intervational

Interventions

  • Othernon intervational

    Subjects who completed ApoGraft-01 study (through 180 days post-transplantation) and have signed informed consent for this follow-up study will be eligible to enroll. Subject will attend 4 in-clinic visits, once every 6 months up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (GvHD) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence)

    Also known as: ApoGraft follow up

05

What researchers measure

Primary outcomes

  1. Incidence, grade and stage of acute GvHD and chronic GvHD

    GVHD will be assessed according to NIH criteria 2005; current and maximal score at each visit.

    Time frame: 18 months

Secondary outcomes

  1. Non-relapse-related mortality

    Time frame: 18 months

  2. Proportion of subjects with disease relapse/recurrence

    Time frame: 18 months

  3. Proportion of subjects with relapse free and overall survival

    Time frame: 18 months

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03260101
Lead sponsor
Cellect Biotechnology
Responsible party
Sponsor
First posted
Aug 24, 2017
Start date
Jun 10, 2018
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Nov 26, 2019

Study contacts

Shai Yarkoni, MD
Contact
shai@cellect.co
972-9-974-1444

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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