LymphomaNCT03200977
Safety of Allogeneic Hematopoietic Cell Transplantation (HCT) For Patients With Classical Hodgkin Lymphoma (CHL) Treated With Nivolumab
An observational study of Lymphoma, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
An observational database analysis, using existing data of patients diagnosed with Classical Hodgkin Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Non-Interventional
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2016to 3 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will target enrollment of 90 patients who were treated with nivolumab-based regimen prior to an allogeneic HCT with at least 45 patients who received nivolumab immediately prior to the allogeneic HCT
Who may be able to join
- Age greater than or equal to18 years;
- First allogeneic HCT for cHL;
- Patients with prior autologous HCT for cHL;
- Any conditioning regimen, graft source or donor type.
- For the primary analysis additional criterion includes prior exposure to nivolumab for treatment of cHL immediately prior to the allogeneic HCT, as defined as nivolumab used alone or in combination with other agents and used as the last line of therapy prior to an allogeneic HCT with the interval between the last dose of nivolumab and start of the conditioning regimen no longer than 12 months.
Who cannot join
- Patients with nodular lymphocyte-predominant HL
- Previous chimeric antigen receptor T-cell therapy or other genetically modified cellular product
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Local Institution - 0001
Lawrenceville, New Jersey, 08543
Center for International Blood and Marrow Transplant Research
Milwaukee, Wisconsin, 53226
About this study
Official title: Observational Cohort Study to Characterize the Safety of Allogeneic Hematopoietic Cell Transplantation (HCT) For Patients With Classical Hodgkin Lymphoma (CHL) Treated With Nivolumab
An observational database analysis, using existing data of patients diagnosed with Classical Hodgkin Lymphoma.
Read the detailed description
This study will include a retrospective and prospective observational database analysis.
- Conditions
- Lymphoma
- Being tested
- Non-Interventional
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Exposed to nivolumab prior to allogeneic HCT | patients who were treated with nivolumab-based regimen prior to an allogeneic HCT Receives: Other: Non-Interventional | |
| Unexposed to nivolumab prior to allogeneic HCT | patients who were not treated with nivolumab-based regimen prior to an allogeneic HCT Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Related Mortality (TRM)
Treatment-Related Mortality at 6 months after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab
Measured: At 6 months after an allogeneic HCT
Secondary outcomes (11)
Incidence of disease progression
Measured by clinical assessment
Measured: Up to 2 years
Incidence of acute Graft Versus Host Disease (GVHD)
Either Grade II-IV or Grade III-IV acute GVHD. Measured by clinical assessment
Measured: Up to 2 years
Incidence of chronic Graft Versus Host Disease (GVHD)
Measured by clinical assessment
Measured: Up to 2 years
Incidence of post-transplant sinusoidal obstruction syndrome (SOS)
Measured by clinical assessment
Measured: Up to 2 years
Incidence of post-transplant interstitial pneumonitis (IPN)
Measured by clinical assessment
Measured: Up to 2 years
Incidence of post-transplant renal toxicity requiring dialysis
Measured by clinical assessment
Measured: Up to 2 years
Overall Survival (OS)
OS is measured from the date of allogeneic transplant to death.
Measured: Up to 2 years
Progression-Free Survival (PFS)
PFS is measured from the date of allogeneic transplant to the date of disease progression or death.
Measured: Up to 2 years
TRM at 100 days
Treatment-Related Mortality at 100 days after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab
Measured: At 100 days after an allogeneic HCT
TRM at 1 year
Treatment-Related Mortality at 1 year after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab
Measured: At 1 year after an allogeneic HCT
TRM at 2 years
Treatment-Related Mortality at 2 years after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab
Measured: At 2 years after an allogeneic HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start1 Jul 2016
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- Other
- Enrolment
- 95 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
- NCT03200977
- Sponsor's protocol ID
- CA209-835
- Status last verified
- Mar 2025
- First submitted
- 26 Jun 2017
- Last updated
- 26 Mar 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study to Characterize the Safety of Allogeneic Hematopoietic Cell Transplantation (HCT) For Patients With Classical Hodgkin Lymphoma (CHL) Treated With Nivolumab
- ClinicalTrials.gov ID
- NCT03200977
- Acronym / sponsor ID
- CA209-835
- Conditions
- Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 27 Jun 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.
An observational database analysis, using existing data of patients diagnosed with Classical Hodgkin Lymphoma.
Detailed description
This study will include a retrospective and prospective observational database analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed to nivolumab prior to allogeneic HCT | – | Other: Non-Interventionalpatients who were treated with nivolumab-based regimen prior to an allogeneic HCT |
| Unexposed to nivolumab prior to allogeneic HCT | – | Other: Non-Interventionalpatients who were not treated with nivolumab-based regimen prior to an allogeneic HCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will target enrollment of 90 patients who were treated with nivolumab-based regimen prior to an allogeneic HCT with at least 45 patients who received nivolumab immediately prior to the allogeneic HCT
Key inclusion criteria (5 listed)
- Age greater than or equal to18 years;
- First allogeneic HCT for cHL;
- Patients with prior autologous HCT for cHL;
- Any conditioning regimen, graft source or donor type.
- For the primary analysis additional criterion includes prior exposure to nivolumab for treatment of cHL immediately prior to the allogeneic HCT, as defined as nivolumab used alone or in combination with other agents and used as the last line of therapy prior to an allogeneic HCT with the interval between the last dose of nivolumab and start of the conditioning regimen no longer than 12 months.
Key exclusion criteria (2 listed)
- Patients with nodular lymphocyte-predominant HL
- Previous chimeric antigen receptor T-cell therapy or other genetically modified cellular product
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-InterventionalNon-Interventional | Other | Exposed to nivolumab prior to allogeneic HCT, Unexposed to nivolumab prior to allogeneic HCT |
Primary outcome
Treatment-Related Mortality (TRM)
Time frame: At 6 months after an allogeneic HCT
Treatment-Related Mortality at 6 months after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab
11 secondary outcomes
Incidence of disease progression
Time frame: Up to 2 years
Incidence of acute Graft Versus Host Disease (GVHD)
Time frame: Up to 2 years
Incidence of chronic Graft Versus Host Disease (GVHD)
Time frame: Up to 2 years
Incidence of post-transplant sinusoidal obstruction syndrome (SOS)
Time frame: Up to 2 years
Incidence of post-transplant interstitial pneumonitis (IPN)
Time frame: Up to 2 years
Incidence of post-transplant renal toxicity requiring dialysis
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Time frame: Up to 2 years
TRM at 100 days
Time frame: At 100 days after an allogeneic HCT
TRM at 1 year
Time frame: At 1 year after an allogeneic HCT
TRM at 2 years
Time frame: At 2 years after an allogeneic HCT
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 26 Mar 2025.
- BMS Clinical Trial InformationLink 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by Bristol-Myers Squibb at 2 sites 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 5 inclusion and 2 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 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Treatment-Related Mortality (TRM) (time frame: At 6 months after an allogeneic HCT). 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 Mar 2025.