Acute Myelogenous Leukemia (AML)NCT03260101
Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study
An observational study of Acute Myelogenous Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL), run by Cellect Biotechnology at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myelogenous Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Non Hodgkin Lymphoma (NHL)
- What is being tested?
- non intervational
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Jun 2018to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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)
Who may be able to join
- Subjects who completed study ApoGraft-01 through 180 days (6 months) post-transplantation
- Ability to comply with the requirements of the study.
- Signed written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Medical Center
Haifa
Tsila Zuckerman, MD, +97247773248, t_zuckerman@rambam.health.gov.il
About this study
Official title: A Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study
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.
- Conditions
- Acute Myelogenous Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Non Hodgkin Lymphoma (NHL), Hodgkin Lymphoma, Adult
- Being tested
- non intervational
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non intervationalOther
Also called ApoGraft follow up
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)
| Study group | Role | What they receive |
|---|---|---|
| one group, ApoGraft Follow up Study | Non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01 Receives: Other: non intervational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (3)
Non-relapse-related mortality
Measured: 18 months
Proportion of subjects with disease relapse/recurrence
Measured: 18 months
Proportion of subjects with relapse free and overall survival
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start10 Jun 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous Leukemia (AML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cellect Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260101
- Sponsor's protocol ID
- ApoGraft01 FU
- Status last verified
- Nov 2019
- First submitted
- 21 Aug 2017
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study
- ClinicalTrials.gov ID
- NCT03260101
- Acronym / sponsor ID
- ApoGraft01 FU
- Conditions
- Acute Myelogenous Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Non Hodgkin Lymphoma (NHL), Hodgkin Lymphoma, Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cellect BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group, ApoGraft Follow up Study | – | Other: non intervationalNon-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- Subjects who completed study ApoGraft-01 through 180 days (6 months) post-transplantation
- Ability to comply with the requirements of the study.
- Signed written informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non intervationalAlso: ApoGraft follow upSubjects 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) | Other | one group, ApoGraft Follow up Study |
Primary outcome
Incidence, grade and stage of acute GvHD and chronic GvHD
Time frame: 18 months
GVHD will be assessed according to NIH criteria 2005; current and maximal score at each visit.
3 secondary outcomes
Non-relapse-related mortality
Time frame: 18 months
Proportion of subjects with disease relapse/recurrence
Time frame: 18 months
Proportion of subjects with relapse free and overall survival
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myelogenous Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL), run by Cellect Biotechnology at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shai Yarkoni, MD (972-9-974-1444, shai@cellect.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, grade and stage of acute GvHD and chronic GvHD (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.