Stem Cell TransplantationNCT05421299
A Study to Assess 7/8 HLA-matched Hematopoietic Stem Cell Transplantation Participants Treated With or Without Abatacept in Combination With a Calcineurin Inhibitor and Methotrexate
An observational study of Stem Cell Transplantation, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to estimate overall survival (OS) for participants treated with abatacept versus those not treated with abatacept prior to hematopoietic stem cell transplantation (HSCT). Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Stem Cell Transplantation
- How many people
- 378 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 15 Feb 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study uses data routinely collected into the Center for International Blood and Marrow Transplant Research (CIBMTR) database. From the patterns of use analysis of the CIBMTR database, the majority of participants who received calcineurin inhibitor (CNI) plus methotrexate (MTX) plus abatacept were treated between 2011 and 2018. The study population has been selected to approximate the inclusion and exclusion criteria of the ABA2 clinical trial as closely as possible.
Who may be able to join
- Participants who underwent first allogenic transplant in the US
- Participants with an unrelated donor who are HLA-matched at 7/8 loci (A, B, C, DRB1)
- Participants at least 6 years old with weight at least 20 kilograms
- Participants with a Karnofsky/Lansky Performance Score ≥80%
- Participants whose first allogeneic transplant occurred from January 1, 2011 to December 31, 2018
- Participants with any of the following diseases: AML, ALL, CML, MDS, HL, NHL
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- Participants with any of the following graft versus host disease (GVHD) prophylaxis treatments:
- CNI plus MTX (with or without ATG and with or without abatacept); or
- Post-transplant cyclophosphamide (PT-Cy) without antithymocyte globulin (ATG)
- Participants treated with any of the following conditioning regiments: total body irradiation (TBI)/cyclophosphamide (Cy), busulfan (Bu)/Cy, Bu/fludarabine (flu), Flu/Melphalan (MEL)
Who cannot join
- Participants with missing information on ATG (yes/no)
- Participants receiving alemtuzumab (Campath)
- Participants with cord blood grafts
- Participants with non-MDS myeloproliferative disorders (NOTE: Participants with chronic myelomonocytic leukemia [CMMoL] will be included)
- Participants who did not consent to participate in research
- Participants treated at embargoed centers for research
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- Participants treated with abatacept and ATG
- Among non-abatacept treated participants, participants transplanted at centers with abatacept trial participants
- Participants with any of the following missing propensity score variables:
- Disease status at transplantation (early, intermediate, advanced HL and NHL-chemosensitive)
- Age
- Gender (male, female)
- HSCT graft source (bone marrow [BM], peripheral blood [PB])
- Conditioning intensity (myeloablative, non-myeloablative / reduced intensity)
- Karnofsky/Lansky Performance Score (80%, 90-100%)
- CNI type (tacrolimus, CsA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Overall Survival in 7/8 HLA-Matched Hematopoietic Stem Cell Transplantation Patients Treated With Abatacept Combined With a Calcineurin Inhibitor and Methotrexate- An Analysis of the Center for International Blood and Marrow Transplant Research (CIBMTR) Database
The purpose of this study is to estimate overall survival (OS) for participants treated with abatacept versus those not treated with abatacept prior to hematopoietic stem cell transplantation (HSCT). Participants were included if their donors were unrelated and had 1-allele mismatched human leukocyte antigen (HLA) status.
- Conditions
- Stem Cell Transplantation
- Keywords
- Abatacept, Orencia, Hematopoietic Stem Cell Transplantation (HSCT), aGVHD Prophylaxis, Unrelated Donor, Mismatched Donor
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 |
|---|---|---|
| Abatacept Group | Participants with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), myelodysplastic syndromes (MDS), hodgkin lymphoma (HL), or non-hodgkin lymphoma (NHL) who have a bone marrow (BM) or peripheral blood (PB) stem cell donor who is HLA-matched at 7/8 loci (A, B, C, DRB1) who received abatacept. | |
| Comparator Group | Participants with AML, ALL, CML, MDS, HL, or NHL who have a BM or PB stem cell donor who is HLA-matched at 7/8 loci (A, B, C, DRB1) who did not receive abatacept. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival in 7/8 HLA-matched Participants Treated with Study Therapy
Measured: Up to 180 days post transplant
Secondary outcomes (2)
Overall Survival in Participants Treated with Study Therapy
Measured: Up to 180 days post transplant
Overall Survival in Participants Treated with Study Therapy Plus Tacrolimus
Measured: Up to 180 days post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start16 Sep 2019
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421299
- Sponsor's protocol ID
- IM101-841
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overall Survival in 7/8 HLA-Matched Hematopoietic Stem Cell Transplantation Patients Treated With Abatacept Combined With a Calcineurin Inhibitor and Methotrexate- An Analysis of the Center for International Blood and Marrow Transplant Research (CIBMTR) Database
- ClinicalTrials.gov ID
- NCT05421299
- Acronym / sponsor ID
- IM101-841
- Conditions
- Stem Cell Transplantation
- Keywords
- Abatacept, Orencia, Hematopoietic Stem Cell Transplantation (HSCT), aGVHD Prophylaxis, Unrelated Donor, Mismatched Donor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 16 Jun 2022 (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 purpose of this study is to estimate overall survival (OS) for participants treated with abatacept versus those not treated with abatacept prior to hematopoietic stem cell transplantation (HSCT). Participants were included if their donors were unrelated and had 1-allele mismatched human leukocyte antigen (HLA) status.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abatacept Group | – | –Participants with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), myelodysplastic syndromes (MDS), hodgkin lymphoma (HL), or non-hodgkin lymphoma (NHL) who have a bone marrow (BM) or peripheral blood (PB) stem cell donor who is HLA-matched at 7/8 loci (A, B, C, DRB1) who received abatacept. |
| Comparator Group | – | –Participants with AML, ALL, CML, MDS, HL, or NHL who have a BM or PB stem cell donor who is HLA-matched at 7/8 loci (A, B, C, DRB1) who did not receive abatacept. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study uses data routinely collected into the Center for International Blood and Marrow Transplant Research (CIBMTR) database. From the patterns of use analysis of the CIBMTR database, the majority of participants who received calcineurin inhibitor (CNI) plus methotrexate (MTX) plus abatacept were treated between 2011 and 2018. The study population has been selected to approximate the inclusion and exclusion criteria of the ABA2 clinical trial as closely as possible.
Key inclusion criteria (10 listed)
- Participants who underwent first allogenic transplant in the US
- Participants with an unrelated donor who are HLA-matched at 7/8 loci (A, B, C, DRB1)
- Participants at least 6 years old with weight at least 20 kilograms
- Participants with a Karnofsky/Lansky Performance Score ≥80%
- Participants whose first allogeneic transplant occurred from January 1, 2011 to December 31, 2018
Key exclusion criteria (16 listed)
- Participants with missing information on ATG (yes/no)
- Participants receiving alemtuzumab (Campath)
- Participants with cord blood grafts
- Participants with non-MDS myeloproliferative disorders (NOTE: Participants with chronic myelomonocytic leukemia [CMMoL] will be included)
- Participants who did not consent to participate in research
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
Overall Survival in 7/8 HLA-matched Participants Treated with Study Therapy
Time frame: Up to 180 days post transplant
2 secondary outcomes
Overall Survival in Participants Treated with Study Therapy
Time frame: Up to 180 days post transplant
Overall Survival in Participants Treated with Study Therapy Plus Tacrolimus
Time frame: Up to 180 days post transplant
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 16 Jun 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 Stem Cell Transplantation, run by Bristol-Myers Squibb at 1 site in United States.
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 10 inclusion and 16 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 16 Jun 2022. 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 United States. 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?
Overall Survival in 7/8 HLA-matched Participants Treated with Study Therapy (time frame: Up to 180 days post transplant). 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 16 Jun 2022.