Acute Myeloid LeukemiaPhase 3HATCYNCT02999854
Safety and Efficacy of ATIR101 as Adjunctive Treatment to Blood Stem Cell Transplantation From a Haploidentical Family Donor Compared to Post-transplant Cyclophosphamide in Patients With Blood Cancer
A Phase 3 study testing ATIR101, Cyclophosphamide and T-cell depleted HSCT from a related, haploidentical donor in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Kiadis Pharma at 42 sites in 13 countries.
Trial summary
The primary objective of this study is to compare safety and efficacy of a haploidentical T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in patients with a hematologic malignancy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- What is being tested?
- ATIR101, Cyclophosphamide and T-cell depleted HSCT from a related, haploidentical donor
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 42 sitesin 13 countries
- Study dates
- 29 Nov 2017to 17 Dec 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any of the following hematologic malignancies:
- Acute myeloid leukemia (AML) in first cytomorphological remission (with < 5% blasts in the bone marrow) with Disease Risk Index (DRI) intermediate or above, or in second or higher cytomorphological remission (with < 5% blasts in the bone marrow)
- Acute lymphoblastic leukemia (ALL) in first or higher remission (with < 5% blasts in the bone marrow)
- Myelodysplastic syndrome (MDS): transfusion-dependent (requiring at least one transfusion per month), or intermediate or higher Revised International Prognostic Scoring System (IPSS-R) risk group
- Clinical justification of allogeneic stem cell transplantation where a suitable HLA matched sibling or unrelated donor is unavailable in a timely manner
- Availability of a related haploidentical donor with one fully shared haplotype and 2 to 4 mismatches at the HLA-A, -B, -C, and -DRB1 loci of the unshared haplotype, as determined by high resolution human leukocyte antigen (HLA)-typing
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- Karnofsky Performance Status (KPS) ≥ 70%
- Male or female, age ≥ 18 years and ≤ 70 years. Patients aged ≥ 65 years must have a Sorror score ≤ 3
- Patient weight ≥ 25 kg and ≤ 130 kg
- Availability of a donor aged ≥ 16 years and ≤ 75 years who is eligible according to local requirements and regulations. Donors aged < 16 years are allowed if they are the only option for an HSCT, if they are permitted by local regulations, and if the IRB/IEC approves participation in the study.
- For females of childbearing potential who are sexually active and males who have sexual contact with a female of childbearing potential: willingness to use of reliable methods of contraception (oral contraceptives, intrauterine device, hormone implants, contraceptive injection or abstinence) during study participation
- Given written informed consent (patient and donor)
Who cannot join
- Diagnosis of chronic myelomonocytic leukemia (CMML)
- Availability of a suitable HLA-matched sibling or unrelated donor in a donor search
- Prior allogeneic hematopoietic stem cell transplantation
- Diffusing capacity for carbon monoxide (hemoglobin corrected DLCO) < 50% predicted
- Left ventricular ejection fraction < 45% (evaluated by echocardiogram or MUGA scan)
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (CTCAE grade 2)
Show all 15Show fewer
- Creatinine clearance < 50 ml/min (calculated or measured)
- Positive pregnancy test or breastfeeding of patient or donor (women of childbearing age only)
- Estimated probability of surviving less than 3 months
- Known allergy to any of the components of ATIR101 (e.g., dimethyl sulfoxide)
- Known hypersensitivity to cyclophosphamide or any of its metabolites
- Any contraindication for GVHD prophylaxis with mycophenolate mofetil, cyclosporine A, or tacrolimus
- Known presence of HLA antibodies against the non-shared donor haplotype
- Positive viral test of the patient or donor for human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B virus (HBV), hepatitis C virus (HCV), Treponema pallidum, human T-lymphotropic virus (HTLV)-1 (if tested), HTLV-2 (if tested), West Nile virus (WNV; if tested), or Zika virus (if tested)
- Any other condition that, in the opinion of the investigator, makes the patient or donor ineligible for the study
Trial locations and contacts
42 sites in 13 countries.
42 sites in 13 countries
United States12 sites
University of Michigan
Ann Arbor, Michigan, 48109-1274
Emory University
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
City of Hope National Medical Center
Duarte, California, 91010
Moores UC San Diego Cancer Center
La Jolla, California, 92037-0698
UCLA Center for Health Sciences
Los Angeles, California, 90095
Weill Cornell Medical College
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Oregon Health & Science University
Portland, Oregon, 97239
Stanford University School of Medicine
Stanford, California, 94305
Stony Brook University Hospital
Stony Brook, New York, 11794
University of Kansas Cancer Center
Westwood, Kansas, 66205
Belgium5 sites
Universitair Ziekenhuis Antwerpen
Antwerp, 2650
Algemeen Ziekenhuis Sint-Jan
Bruges, 8000
Institut Jules Bordet
Brussels, 1000
Universitair Ziekenhuis Gasthuisberg
Leuven, 3000
Centre Hospitalier Universitaire de Liège
Liège, 4000
United Kingdom5 sites
Heartlands Hospital
Birmingham, B9 5SS
St James University Hospital
Leeds, LS9 7TF
Royal Liverpool University Hospital
Liverpool, L7 8XP
Hammersmith Hospital
London, W12 0HS
Manchester Royal Infirmary
Manchester, M13 9WL
Germany4 sites
University Hospital Frankfurt, Goethe University
Frankfurt
University Medical Center Mainz
Mainz, 55131
Ludwig-Maximilians-University Hospital of Munich-Grosshadern
Munich, 81377
Universitätsklinikum Würzburg
Würzburg, 97080
Israel4 sites
Rambam Medical Center
Haifa, 3109601
Hadassah Medical Center & Hadassah Hospital Ein Karem
Jerusalem, 91120
Sourasky Medical Center & Tel Aviv University
Tel Aviv, 6423906
Chaim Sheba Medical Center
Tel HaShomer, 5265601
Spain4 sites
University Hospital Barcelona Vall d' Hebron
Barcelona, 08035
Hospital Puerta de Hierro Majadahonda
Madrid, 28220
UGC Hematología y Hemoterapia
Seville, 41013
Servicio de Hematología Hospital, Universitari I politècnic La Fe
Valencia, 46026
Italy2 sites
Milano Hospital, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Portugal1 site
Faculdade de Medicina da Universidade de Lisboa
Lisbon, 1649-028
About this study
Official title: A Phase III, Multicenter, Randomized Controlled Study to Compare Safety and Efficacy of a Haploidentical HSCT and Adjunctive Treatment With ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells, Versus a Haploidentical HSCT With Post-transplant Cyclophosphamide in Patients With a Hematologic Malignancy
The primary objective of this study is to compare safety and efficacy of a haploidentical T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in patients with a hematologic malignancy. An additional objective of the study is to compare the effect of the two treatments on quality of life.
Read the detailed description
Study CR-AIR-009 is a Phase III randomized controlled multicenter open-label study comparing two parallel groups. After signing informed consent, a total of 250 patients will be randomized in a 1:1 fashion to receive either a T-cell depleted hematopoietic stem cell transplantation (HSCT; CD34 selection) from a related, haploidentical donor, followed by ATIR101 infusion, or a T-cell replete HSCT, followed by a high dose of post-transplant cyclophosphamide (PTCy).
Randomization will use minimization to balance treatment groups with respect to underlying disease (AML, ALL, or MDS), Disease Risk Index (DRI; intermediate risk, high risk, or very high risk) and center. A stochastic treatment allocation procedure will be used so that the treatment assignment is random for all patients entered in the study.
Patients randomized in the ATIR101 group will receive a single ATIR101 dose of 2×10E6 viable T-cells/kg between 28 and 32 days after the HSCT. Patients randomized in the PTCy group will receive cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT. All patients will be followed up for at least 24 months post HSCT.
- Being tested
- ATIR101, Cyclophosphamide, T-cell depleted HSCT from a related, haploidentical donor, T-cell replete HSCT from a related, haploidentical donor
- Keywords
- Haploidentical stem cell transplantation, Graft-versus-host disease, Immune reconstitution, Alloreactive T-cells, Photodynamic treatment, Hematologic malignancy, Transplant-related mortality, Overall survival, GRFS, GVHD
- 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.
ATIR101Biological
ATIR101 is a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells using photodynamic treatment; single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT (intravenous infusion)
CyclophosphamideDrug
High dose post-transplant cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT (powder for intravenous infusion)
T-cell depleted HSCT from a related, haploidentical donorProcedure or surgery
T-cell depleted graft prepared from peripheral blood stem cells using the CD34+ cell selection method; infused after a total body irradiation (TBI) or non-TBI conditioning regimen
T-cell replete HSCT from a related, haploidentical donorProcedure or surgery
T-cell replete (full, non-manipulated) graft prepared from either bone marrow or peripheral blood stem cells; infused after a total body irradiation (TBI) or non-TBI conditioning regimen
| Study group | Role | What they receive |
|---|---|---|
| ATIR101 | Experimental | T-cell depleted HSCT from a related, haploidentical donor, followed by IV infusion with ATIR101 at a single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT Receives: Biological: ATIR101; Procedure: T-cell depleted HSCT from a related, haploidentical donor |
| PTCy | Active comparator | T-cell replete HSCT from a related, haploidentical donor, followed by IV infusion of post-transplant cyclophosphamide (PTCy) 50 mg/kg/day at 3 and 4/5 days after the HSCT Receives: Drug: Cyclophosphamide; Procedure: T-cell replete HSCT from a related, haploidentical donor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft-versus-host Disease-free, Relapse-free Survival (GRFS)
Defined as the time until acute GVHD grade III/IV, chronic GVHD requiring systemic treatment, relapse, or death, whichever occurs first. Kaplan-Meier estimates (percentage of participants) of GRFS were calculated at 24 months post HSCT.
Measured: 24 months post-HSCT
Secondary outcomes (4)
Overall Survival (OS)
OS is defined as the time from HSCT until death from any cause. Kaplan-Meier estimates (percentage of participants) of OS were calculated at 24 months post HSCT.
Measured: 24 months post-HSCT
Progression-free Survival (PFS)
Defined as the time from HSCT until relapse, disease progression, or death, whichever occurs first. Kaplan-Meier estimates (percentage of participants) of PFS were calculated at 24 months post HSCT.
Measured: 24 months post-HSCT
Relapse-related Mortality (RRM)
Time from randomization to death due to disease relapse or disease progression
Measured: Through study completion, at least two years post HSCT
Transplant-related Mortality (TRM)
Defined as death due to causes other than disease relapse or progression, or other causes which are unrelated to the transplantation procedure (e.g. accident, suicide). Kaplan-Meier estimates (percentage of participants) of PFS were calculated at 24 months post HSCT.
Measured: 24 months post-HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start29 Nov 2017
- Primary completion9 Nov 2021
- Study completion17 Dec 2021
Why it stopped: Insufficient efficacy, terminated by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kiadis Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denis Claude Roy, Prof MD, Principal investigator, Research Center and Cellular Therapy Laboratory, Maisonneuve-Rosemont Hospital (Montreal, Canada)Stephan Mielke, Prof MD, Principal investigator, Centre for Allogeneic Stem Cell Transplantation, Karolinska University Hospital (Stockholm, Sweden)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999854
- Sponsor's protocol ID
- CR-AIR-009
- Other IDs
- 2016-004672-21, 2016
- Acronym
- HATCY
- Status last verified
- Apr 2022
- First submitted
- 19 Dec 2016
- Last updated
- 24 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized Controlled Study to Compare Safety and Efficacy of a Haploidentical HSCT and Adjunctive Treatment With ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells, Versus a Haploidentical HSCT With Post-transplant Cyclophosphamide in Patients With a Hematologic Malignancy
- ClinicalTrials.gov ID
- NCT02999854
- Acronym / sponsor ID
- HATCY / CR-AIR-009
- Keywords
- Haploidentical stem cell transplantation, Graft-versus-host disease, Immune reconstitution, Alloreactive T-cells, Photodynamic treatment, Hematologic malignancy, Transplant-related mortality, Overall survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient efficacy, terminated by Sponsor
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Kiadis PharmaIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Posted 24 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare safety and efficacy of a haploidentical T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in patients with a hematologic malignancy. An additional objective of the study is to compare the effect of the two treatments on quality of life.
Detailed description
Study CR-AIR-009 is a Phase III randomized controlled multicenter open-label study comparing two parallel groups. After signing informed consent, a total of 250 patients will be randomized in a 1:1 fashion to receive either a T-cell depleted hematopoietic stem cell transplantation (HSCT; CD34 selection) from a related, haploidentical donor, followed by ATIR101 infusion, or a T-cell replete HSCT, followed by a high dose of post-transplant cyclophosphamide (PTCy).
Randomization will use minimization to balance treatment groups with respect to underlying disease (AML, ALL, or MDS), Disease Risk Index (DRI; intermediate risk, high risk, or very high risk) and center. A stochastic treatment allocation procedure will be used so that the treatment assignment is random for all patients entered in the study.
Patients randomized in the ATIR101 group will receive a single ATIR101 dose of 2×10E6 viable T-cells/kg between 28 and 32 days after the HSCT. Patients randomized in the PTCy group will receive cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT. All patients will be followed up for at least 24 months post HSCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATIR101 | Experimental | Biological: ATIR101, Procedure: T-cell depleted HSCT from a related, haploidentical donorT-cell depleted HSCT from a related, haploidentical donor, followed by IV infusion with ATIR101 at a single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT |
| PTCy | Active comparator | Drug: Cyclophosphamide, Procedure: T-cell replete HSCT from a related, haploidentical donorT-cell replete HSCT from a related, haploidentical donor, followed by IV infusion of post-transplant cyclophosphamide (PTCy) 50 mg/kg/day at 3 and 4/5 days after the HSCT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Any of the following hematologic malignancies:
- Clinical justification of allogeneic stem cell transplantation where a suitable HLA matched sibling or unrelated donor is unavailable in a timely manner
- Availability of a related haploidentical donor with one fully shared haplotype and 2 to 4 mismatches at the HLA-A, -B, -C, and -DRB1 loci of the unshared haplotype, as determined by high resolution human leukocyte antigen (HLA)-typing
- Karnofsky Performance Status (KPS) ≥ 70%
- Male or female, age ≥ 18 years and ≤ 70 years. Patients aged ≥ 65 years must have a Sorror score ≤ 3
Key exclusion criteria (15 listed)
- Diagnosis of chronic myelomonocytic leukemia (CMML)
- Availability of a suitable HLA-matched sibling or unrelated donor in a donor search
- Prior allogeneic hematopoietic stem cell transplantation
- Diffusing capacity for carbon monoxide (hemoglobin corrected DLCO) < 50% predicted
- Left ventricular ejection fraction < 45% (evaluated by echocardiogram or MUGA scan)
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 |
|---|---|---|
| ATIR101ATIR101 is a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells using photodynamic treatment; single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT (intravenous infusion) | Biological | ATIR101 |
| CyclophosphamideHigh dose post-transplant cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT (powder for intravenous infusion) | Drug | PTCy |
| T-cell depleted HSCT from a related, haploidentical donorT-cell depleted graft prepared from peripheral blood stem cells using the CD34+ cell selection method; infused after a total body irradiation (TBI) or non-TBI conditioning regimen | Procedure or surgery | ATIR101 |
| T-cell replete HSCT from a related, haploidentical donorT-cell replete (full, non-manipulated) graft prepared from either bone marrow or peripheral blood stem cells; infused after a total body irradiation (TBI) or non-TBI conditioning regimen | Procedure or surgery | PTCy |
Primary outcome
Graft-versus-host Disease-free, Relapse-free Survival (GRFS)
Time frame: 24 months post-HSCT
Defined as the time until acute GVHD grade III/IV, chronic GVHD requiring systemic treatment, relapse, or death, whichever occurs first. Kaplan-Meier estimates (percentage of participants) of GRFS were calculated at 24 months post HSCT.
4 secondary outcomes
Overall Survival (OS)
Time frame: 24 months post-HSCT
Progression-free Survival (PFS)
Time frame: 24 months post-HSCT
Relapse-related Mortality (RRM)
Time frame: Through study completion, at least two years post HSCT
Transplant-related Mortality (TRM)
Time frame: 24 months post-HSCT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Denis Claude Roy, Prof MD principal investigator
Research Center and Cellular Therapy Laboratory, Maisonneuve-Rosemont Hospital (Montreal, Canada)
Stephan Mielke, Prof MD principal investigator
Centre for Allogeneic Stem Cell Transplantation, Karolinska University Hospital (Stockholm, Sweden)
42 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ATIR101, Cyclophosphamide and T-cell depleted HSCT from a related, haploidentical donor in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Kiadis Pharma at 42 sites in 13 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 12 inclusion and 15 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: stopped early, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Belgium, United Kingdom, Germany, Israel and 8 more countries. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 24 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Graft-versus-host Disease-free, Relapse-free Survival (GRFS) (time frame: 24 months post-HSCT). 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 24 May 2022.