Acute Myeloid LeukemiaNCT02188290
Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation
An observational study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Kiadis Pharma at 9 sites in 6 countries.
Trial summary
Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- How many people
- 178 participants
- Where
- 9 sitesin 6 countries
- Study dates
- Sep 2014to Jun 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having received a haploidentical hematopoietic stem cell transplantation (HSCT) between 1 January 2006 and 30 June 2014, an HSCT from an unrelated donor between 1 January 2010 and 31 December 2012, or a double UCB transplantation between 1 January 2010 and 31 December 2012 will be selected from the centers that enrolled patients in study CR-AIR-004 and/or study CR-AIR-007.
Who may be able to join
- Any of the following hematologic malignancies:
- Acute myeloid leukemia (AML) in remission at the time of the transplantation
- Acute lymphoblastic leukemia (ALL) in remission at the time of the transplantation
- Myelodysplastic syndrome (MDS)
- Patient received any of the following transplantations:
- Allogeneic T-cell depleted HSCT without ATIR administration from a haploidentical donor between 1 January 2006 and 30 June 2013 (HAPLO group)
Show all 9Show fewer
- Allogeneic HSCT from a fully matched or 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012 (MUD/MMUD groups)
- Double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012 with no more than 2 human leukocyte antigen (HLA)-mismatches at HLA-A, B, and/or -DR between each of the units and the recipient (UCB group)
- Male or female, age ≥ 18, ≤ 65 years.
Who cannot join
- Allogeneic stem cell transplantation prior to the transplantation qualifying for the study.
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Belgium3 sites
Algemeen Ziekenhuis Sint-Jan
Bruges, 8000
Institut Jules Bordet
Brussels, 1000
Universitair Ziekenhuis Gasthuisberg
Leuven, 3000
Canada2 sites
Hamilton Niagara Regional Haemophilia Centre
Hamilton, Ontario, L8N 3Z5
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: An Observational Cohort Study on Transplant-Related Mortality in Patients Receiving Either a Hematopoietic Stem Cell Transplantation Without ATIR or an Umbilical Cord Blood Transplantation
Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).
- Keywords
- Haploidentical donor, Unrelated donor, Umbilical cord blood, Graft versus host disease, Transplant-related mortality, Hematologic malignancy, Hematopoietic Stem Cell Transplantation
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Graft vs Host Disease, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HAPLO group | Control group of all eligible patients who received an HSCT from a haploidentical donor without ATIR administration between 1 January 2006 and 30 June 2013 | |
| MUD group | Control group of eligible patients who received an HSCT from a fully matched unrelated donor between 1 January 2010 and 31 December 2012 | |
| MMUD group | Control group of eligible patients who received an HSCT from a 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012 | |
| UCB group | Control group of eligible patients who received a double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant-related mortality
Measured: Up to 12 months after the transplantation
Secondary outcomes (5)
Overall survival
Measured: Up to 12 months after the transplantation
Incidence of acute and chronic graft versus host disease
Measured: Up to 12 months after the transplantation
Progression-free survival
Measured: Up to 12 months after the transplantation
Severity of acute and chronic graft versus host disease
Measured: Up to 12 months after the transplantation
Relapse-related mortality
Measured: Up to 12 months after the transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kiadis Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeroen Rovers, MD, Study chair, Kiadis Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188290
- Sponsor's protocol ID
- CR-AIR-006
- Status last verified
- Oct 2015
- First submitted
- 10 Jul 2014
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study on Transplant-Related Mortality in Patients Receiving Either a Hematopoietic Stem Cell Transplantation Without ATIR or an Umbilical Cord Blood Transplantation
- ClinicalTrials.gov ID
- NCT02188290
- Acronym / sponsor ID
- CR-AIR-006
- Keywords
- Haploidentical donor, Unrelated donor, Umbilical cord blood, Graft versus host disease, Transplant-related mortality, Hematologic malignancy, Hematopoietic Stem Cell Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Kiadis PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Jul 2014 (estimated)
- 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.
Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HAPLO group | – | –Control group of all eligible patients who received an HSCT from a haploidentical donor without ATIR administration between 1 January 2006 and 30 June 2013 |
| MUD group | – | –Control group of eligible patients who received an HSCT from a fully matched unrelated donor between 1 January 2010 and 31 December 2012 |
| MMUD group | – | –Control group of eligible patients who received an HSCT from a 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012 |
| UCB group | – | –Control group of eligible patients who received a double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having received a haploidentical hematopoietic stem cell transplantation (HSCT) between 1 January 2006 and 30 June 2014, an HSCT from an unrelated donor between 1 January 2010 and 31 December 2012, or a double UCB transplantation between 1 January 2010 and 31 December 2012 will be selected from the centers that enrolled patients in study CR-AIR-004 and/or study CR-AIR-007.
Key inclusion criteria (9 listed)
- Any of the following hematologic malignancies:
- Patient received any of the following transplantations:
- Male or female, age ≥ 18, ≤ 65 years.
Key exclusion criteria (1 listed)
- Allogeneic stem cell transplantation prior to the transplantation qualifying for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transplant-related mortality
Time frame: Up to 12 months after the transplantation
5 secondary outcomes
Overall survival
Time frame: Up to 12 months after the transplantation
Incidence of acute and chronic graft versus host disease
Time frame: Up to 12 months after the transplantation
Progression-free survival
Time frame: Up to 12 months after the transplantation
Severity of acute and chronic graft versus host disease
Time frame: Up to 12 months after the transplantation
Relapse-related mortality
Time frame: Up to 12 months after the transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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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.
Jeroen Rovers, MD study chair
Kiadis Pharma
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Kiadis Pharma at 9 sites in 6 countries.
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 9 inclusion and 1 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: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium, Canada, United States, Germany, Netherlands and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant-related mortality (time frame: Up to 12 months after the transplantation). 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 6 Oct 2015.