Acute Myeloid Leukemia in RemissionPhase 2/3Predictor2NCT03887156
Evaluation of a Donor Testing Kit for the Prediction of AGVHD in Patient Receiving a Peripheral Blood Stem Cell Allograft
A Phase 2/3 study testing Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor test in people with Acute Myeloid Leukemia in Remission and Lymphoma in Remission, run by Assistance Publique - Hôpitaux de Paris at 22 sites in 3 countries.
Trial summary
The aim is to validate an in vitro diagnosis medical device to predict grade II to IV aGVHD after a cell graft Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia in Remission, Lymphoma in Remission, Non-progressive Myeloproliferative Syndrome
- What is being tested?
- Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 16 Sep 2019to 16 Mar 2023
- Phase
- Phase 2/3
- 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
Who may be able to join
- PATIENT :
- Age between 18 and 65 years ( included )
- Being candidate to a graft of peripheral hematopoietic stem cells , according the following criteria :
- HLA compatibility 10 / 10 with the selected donor
- Malignant haematological disorder as described below :
- Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia ( ALL) in 1st or 2d complete remission
Show all 16Show fewer
- Aggressive lymphoma in complete remission
- Non - progressive myeloproliferative syndrome ,
- Myelodysplasia with stable blasts is cell number and < 10 % of blastocysts,
- Acute leukemia biphenotypic in 1st or 2d complete remission
- Sequential graft conditioning, myeloablative or with a reduced intensity, both may include ATG
- Classical scheme for immunosuppression decrease ( from day 90 to day 180 ) • Not being opposed to medical data collection DONOR
- Adult ( ≥ 18 year old) up to the maximum authorized by each National Transplantation Authority
- Being a patient's sibling or registered in the Bone Marrow Donors Worldwide registry or a national registry
- Being candidate to a Peripheral Blood Stem Cells donation with a Human Leucocyt Antigen (HLA) 10 / 10 compatibility with the recipient ,
- Signed and dated informed consent ( in accordance with local regulation of the country in which the observation is performed )
Who cannot join
- Participating in a clinical trial, if interventional on the prophylaxis treatment ( not on the prophylaxis ) of GVHD, in the 30 days prior to the inclusion and during the Predictor 2 study ,
- Being placed under legal supervision ,
- Presenting any impossibility to fulfil the study requirements, due to geographical, social or physical reasons
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
France16 sites, 16 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens, 80054
Magalie JORIS, Dr, 03 22 45 59 20, joris.magalie@chu-amiens.fr
- Recruiting
CHU Angers
Angers, 49033
Sylvie FRANCOIS, Dr, 02.41.35.44.75, sylvie.francois@chu-angers.fr
- Recruiting
CHU de Caen
Caen, 14033
Hyacinthe Atchroué JOHNSON-ANSAH, Dr, 02 31 27 20 20, johnsonansah-a@chu-caen.fr
- Recruiting
HIA Percy
Clamart, 92190
Jean-Valère MALFUSON, Pr, 01.41.46.63.07, jvmalf@free.fr
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Lemal RICHARD, Dr, 04 73 75 00 65, rlemal@chu-clermontferrand.fr
- Recruiting
Hôpital Dupuyten
Limoges, 87042
Arnaud JACCARD, Dr, 05 55 05 66 52, arnaud.jaccard@chu-limoges.fr
- Recruiting
Hôtel Dieu
Nantes, 44035
Patrice CHEVALLIER, Dr, 02.40.08.32.69, patrice.chevallier@chu-nantes.fr
- Recruiting
CHU Nice
Nice, 06002
Pierre-Simon ROHRLICH, Dr, 04 92 03 58 41, rohrlich.ps@chu-nice.fr
- Recruiting
Hôpital de la Pitiè-Salpétrière
Paris, 75013
Stéphanie NGUYEN-QUOC, Pr, 01 42 16 28 25, stephanie.nguyen-quoc@aphp.fr
- Recruiting
Hôpital Necker Enfants Malades
Paris, 75015
Olivier HERMINE, Pr, 01.44.49.52.82, ohermine@gmail.com
- Recruiting
CHU Bordeaux
Pessac, 33604
Carmen BOTELLA GARCIA, Dr, 05 57 65 65 11, carmen.botella-garcia@chu-bordeaux.fr
- Recruiting
CHU de Poitiers
Poitiers, 86000
Natacha MAILLARD, Dr, 05.49.44.43.07, natacha.maillard@chu-poitiers.fr
- Recruiting
CHU de Rennes
Rennes, 35033
Marc BERNARD, Dr, 02 99 28 43 21, marc.bernard@chu-rennes.fr
- Recruiting
L'Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270
Emilie CHALAYER, Dr, 04 77 91 70 60, emilie.chamayer@icloire.fr
- Recruiting
Institut Universitaire du Cancer de Toulouse
Toulouse, 31059
Anne HUYNH, Dr, 05 31 15 63 54, huynh.anne@iuct-oncopole.fr
- Recruiting
CHRU Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, 54511
Marie-Thérèse RUBIO, 03 83 15 32 82, mt_rubio@hotmail.com
Belgium3 sites, 3 recruiting
- Recruiting
Z.N.A. Stuivenberg Ziekenhuis
Antwerp, 2060
Dimitri BREEMS, 0032 3 217 73 97, dimitri.breems@zna.be
Ka Lung WU
- Recruiting
CHU Liège
Liège, 4000
Yves BEGUIN, Pr, 003243667201, yves.beguin@chu.ulg.ac.be
Evelyne WILLENS, Dr
- Recruiting
U.Z. Antwerpen
Wilrijk, 2610
Anke VERLINDEN, Dr, 0032 478 27 86 24, anke.verlinden@uza.be
Germany3 sites, 1 recruiting
- Active, not recruiting
Donor Site - Koln
Cologne
- Active, not recruiting
Donor Site-Dresden
Dresden
- Recruiting
Medizinische Hochschule Hannover
Hanover
Michael STADLER
About this study
Official title: Evaluation of a Donor Testing Kit for the Prediction of Acute GVHD in Patient Receiving a Peripheral Blood Stem Cells Allograft- Predictor 2
The aim is to validate an in vitro diagnosis medical device to predict grade II to IV aGVHD after a cell graft
Read the detailed description
Acute Graft Versus Host Disease (aGVHD) is the most frequent complication in allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT). It affects up to 50% patients, among whom 15% to 25% develop severe forms, often lethal, yet impossible to predict even for donors with a Human Leukocyte Antigene (HLA) 10/10 compatibility. Global Overall Survival (OS) after transplantation is 40% to 60% only due to post transplant severe complications. There is a major medical need for a technology that would predict the risk of aGVHD and would allow the selection of a favourable donor among multiple Human Leukocyte Antigene (HLA)10/10 compatible donors.
MT. Rubio and M. Bouillié at Pr Olivier Hermine's lab previously reported that enhanced early post-transplant invariant Natural Killer T (iNKT) cells reconstitution from donor cells was correlated to reduced risk of aGVHD, without impairment of the Graft Versus Leukemia (GVL) effect. They subsequently demonstrated that the expansion of donors CD4neg invariant Natural Killer T (iNKT) cells subpopulation was predictive of a reduced risk of aGVHD, and developed a method for predicting this risk based on the expansion factor of CD4neg invariant Natural Killer T (iNKT) cells in the peripheral blood stem cell (PBSC) graft. This invariant Natural Killer T (iNKT) cells functional test reaches its optimal predictive capacity with 94% sensitivity and 100% specificity in allo-HSCT performed with Human Leukocyte Antigene (HLA) 10/10 matched peripheral blood stem cell (PBSC) grafts for non-progressive hematological malignant diseases, in complete response, which represent the majority of the indications of allogeneic HSCT. Similar predictive value was also observed when the test was performed from donor's peripheral blood before G-CSF mobilization. It was not associated with an increased risk of relapse. This test could therefore allow to easily selecting the best donor if different siblings or unrelated donors are available before PBSC allo-HSCT.
- Conditions
- Acute Myeloid Leukemia in Remission, Lymphoma in Remission, Non-progressive Myeloproliferative Syndrome, Myelodysplasia With Stable Blasts is Cell Number and < 10% of Blastocysts, Acute Leukemia Biphenotypic in Remission, Acute Lymphoblastic Leukemia
- Being tested
- Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor test
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor testDiagnostic test
Calculation of ex vivo capacities of CD4neg INkT expansion of the peripheral blood from an identified donor for an allograft. Sample is collected before mobilization and the blood culture and analysis using the Predictor test are performed by the central lab.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | One arm Receives: Diagnostic Test: Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of aGVHD of grade II to IV observed for the recipients
To predict the risk of acute GVHD. Number of aGVHD of grade II to IV observed for the recipients in the 3 months after the graft and results of the Predictor test, before graft, on their own donor's blood.
Measured: 3 month after allograft performance
Secondary outcomes (4)
Evaluation of medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment
Number of hospitalization or medical consultation, exams, concomitant treatments.
Measured: 3 month after allograft performance.
Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment
Number of medical consultations
Measured: 3 month after allograft performance.
Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment
Number of exams
Measured: 3 month after allograft performance.
Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment
Number of concomitant treatments
Measured: 3 month after allograft performance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start16 Sep 2019
- Primary completion16 Mar 2023 (estimated)
- Study completion16 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukemia in RemissionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 227 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- SATT, SNC Graft Versus Host Disease, Imagine Institute, Axonal-Biostatem, CERBA laboratory
- Responsible party
- Sponsor
- Investigators
- Olivier Hermine, MD, Principal investigator, Head of adult hematology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887156
- Sponsor's protocol ID
- K180304J
- Acronym
- Predictor2
- Status last verified
- Sep 2021
- First submitted
- 12 Mar 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rubio MT, Bouillie M, Bouazza N, Coman T, Trebeden-Negre H, Gomez A, Suarez F, Sibon D, Brignier A, Paubelle E, Nguyen-Khoc S, Cavazzana M, Lantz O, Mohty M, Urien S, Hermine O. Pre-transplant donor CD4- invariant NKT cell expansion capacity predicts the occurrence of acute graft-versus-host disease. Leukemia. 2017 Apr;31(4):903-912. doi: 10.1038/leu.2016.281. Epub 2016 Oct 14.
PubMed 27740636
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Donor Testing Kit for the Prediction of Acute GVHD in Patient Receiving a Peripheral Blood Stem Cells Allograft- Predictor 2
- ClinicalTrials.gov ID
- NCT03887156
- Acronym / sponsor ID
- Predictor2 / K180304J
- Conditions
- Acute Myeloid Leukemia in Remission, Lymphoma in Remission, Non-progressive Myeloproliferative Syndrome, Myelodysplasia With Stable Blasts is Cell Number and < 10% of Blastocysts, Acute Leukemia Biphenotypic in Remission, Acute Lymphoblastic Leukemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 227 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- SATT, SNC Graft Versus Host Disease, Imagine Institute, Axonal-Biostatem, CERBA laboratory
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 16 Mar 2023 (estimated)
- Study completion
- 16 Mar 2023 (estimated)
- First posted
- 22 Mar 2019 (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.
The aim is to validate an in vitro diagnosis medical device to predict grade II to IV aGVHD after a cell graft
Detailed description
Acute Graft Versus Host Disease (aGVHD) is the most frequent complication in allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT). It affects up to 50% patients, among whom 15% to 25% develop severe forms, often lethal, yet impossible to predict even for donors with a Human Leukocyte Antigene (HLA) 10/10 compatibility. Global Overall Survival (OS) after transplantation is 40% to 60% only due to post transplant severe complications. There is a major medical need for a technology that would predict the risk of aGVHD and would allow the selection of a favourable donor among multiple Human Leukocyte Antigene (HLA)10/10 compatible donors.
MT. Rubio and M. Bouillié at Pr Olivier Hermine's lab previously reported that enhanced early post-transplant invariant Natural Killer T (iNKT) cells reconstitution from donor cells was correlated to reduced risk of aGVHD, without impairment of the Graft Versus Leukemia (GVL) effect. They subsequently demonstrated that the expansion of donors CD4neg invariant Natural Killer T (iNKT) cells subpopulation was predictive of a reduced risk of aGVHD, and developed a method for predicting this risk based on the expansion factor of CD4neg invariant Natural Killer T (iNKT) cells in the peripheral blood stem cell (PBSC) graft. This invariant Natural Killer T (iNKT) cells functional test reaches its optimal predictive capacity with 94% sensitivity and 100% specificity in allo-HSCT performed with Human Leukocyte Antigene (HLA) 10/10 matched peripheral blood stem cell (PBSC) grafts for non-progressive hematological malignant diseases, in complete response, which represent the majority of the indications of allogeneic HSCT. Similar predictive value was also observed when the test was performed from donor's peripheral blood before G-CSF mobilization. It was not associated with an increased risk of relapse. This test could therefore allow to easily selecting the best donor if different siblings or unrelated donors are available before PBSC allo-HSCT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Diagnostic Test: Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor testOne arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- PATIENT :
- HLA compatibility 10 / 10 with the selected donor
- Malignant haematological disorder as described below :
- Sequential graft conditioning, myeloablative or with a reduced intensity, both may include ATG
- Classical scheme for immunosuppression decrease ( from day 90 to day 180 ) • Not being opposed to medical data collection DONOR
Key exclusion criteria (3 listed)
- Participating in a clinical trial, if interventional on the prophylaxis treatment ( not on the prophylaxis ) of GVHD, in the 30 days prior to the inclusion and during the Predictor 2 study ,
- Being placed under legal supervision ,
- Presenting any impossibility to fulfil the study requirements, due to geographical, social or physical reasons
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 |
|---|---|---|
| Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor testCalculation of ex vivo capacities of CD4neg INkT expansion of the peripheral blood from an identified donor for an allograft. Sample is collected before mobilization and the blood culture and analysis using the Predictor test are performed by the central lab. | Diagnostic test | Arm 1 |
Primary outcome
Number of aGVHD of grade II to IV observed for the recipients
Time frame: 3 month after allograft performance
To predict the risk of acute GVHD. Number of aGVHD of grade II to IV observed for the recipients in the 3 months after the graft and results of the Predictor test, before graft, on their own donor's blood.
4 secondary outcomes
Evaluation of medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment
Time frame: 3 month after allograft performance.
Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment
Time frame: 3 month after allograft performance.
Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment
Time frame: 3 month after allograft performance.
Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment
Time frame: 3 month after allograft performance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 27740636Rubio MT, Bouillie M, Bouazza N, Coman T, Trebeden-Negre H, Gomez A, Suarez F, Sibon D, Brignier A, Paubelle E, Nguyen-Khoc S, Cavazzana M, Lantz O, Mohty M, Urien S, Hermine O. Pre-transplant donor CD4- invariant NKT cell expansion capacity predicts the occurrence of acute graft-versus-host disease. Leukemia. 2017 Apr;31(4):903-912. doi: 10.1038/leu.2016.281. Epub 2016 Oct 14.
- 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.
Olivier Hermine, MD principal investigator
Head of adult hematology department
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor test in people with Acute Myeloid Leukemia in Remission and Lymphoma in Remission, run by Assistance Publique - Hôpitaux de Paris at 22 sites in 3 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 16 inclusion and 3 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 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France, Belgium, Germany. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yannick VACHER (+33 1 44 84 17 30, yannick.vacher@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of aGVHD of grade II to IV observed for the recipients (time frame: 3 month after allograft performance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03887156, which also lists 1 linked publication.
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 28 Sep 2021.