Hodgkin LymphomaNCT03664323
Anti-PD-1 and Chemotherapy for R/R Hodgkin Lymphoma
An observational study of Hodgkin Lymphoma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Anti-PD-1 therapy provides high response rates in Hodgkin lymphoma (HL) patients who have relapsed or are refractory (R/R) to autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV), but median progression free survival (PFS) is only one year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Evaluate the improvement in response from the end of anti-PD-1 monotherapy
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2018to 30 Jun 2018
- 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
- Adult, Older adult
Study population: The initial diagnosis of classical HL was established from biopsies in accordance with the 2008 World Health Organization classification14. We retrospectively analyzed 30 R/R classical HL patients from 14 LYSA centers who received anti-PD-1 therapy as part of a clinical trial (n=4), from an off-label program authorization for temporary use (ATU) from the French medical drug agency (Agence Nationale de Sécurité du Médicament, ANSM) (n=22), from the Belgian national system for the reimbursement of health care (Institut National d'Assurance Maladie Invalidité, INAMI) (n=4).
Who may be able to join
- Initial diagnosis of classical HL
- Optional histopathology confirmation of relapse/refractory HL, (2) age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 to 2
- Patients must be have received: at least 2 prior regimens and have received or be ineligible for autologous stem cell transplant and must have received prior BV, and at least 2 cycles of single agent anti-PD-1 as last treatment before entering the study,
- Patients must have inadequate response to anti-PD-1 monotherapy (progressive disease or partial response according to Lugano criteria) with at least one hypermetabolic lesion over the liver and mediastinum background at time of inclusion in the study
- Previous allogeneic stem cell transplant was allowed. Patients treated with radiotherapy alone after anti-PD1 or combined with anti-PD1 treatment were not included in the study.
Who cannot join
- radiotherapy in the treatment after anti-PD1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Chemotherapy or Chemo-anti-PD-1 Combination After Failed Anti-PD-1 Therapy for Relapsed and Refractory Hodgkin Lymphoma: a Series From Lysa Centers.
Anti-PD-1 therapy provides high response rates in Hodgkin lymphoma (HL) patients who have relapsed or are refractory (R/R) to autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV), but median progression free survival (PFS) is only one year. The efficacy of treatment following anti-PD-1 is not well known.
In this context, the optimal treatment for patients who failed after anti-PD-1 therapy is an issue. To better assess their outcome, the investigators retrospectively analyzed the characteristics and outcome of patients from 14 LYSA (The Lymphoma Study Association) centers who lost response to anti-PD-1 therapy and received additional CT.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Evaluate the improvement in response from the end of anti-PD-1 monotherapy
- Keywords
- Immunotherapy, chemotherapy, anti-PD1, re-sensibilization
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate the improvement in response from the end of anti-PD-1 monotherapyBiological
Evaluate the improvement in response from the end of anti-PD-1 monotherapy to the first evaluation after introduction of CT alone (Group 1) or combined with anti-PD-1 (Group 2).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Sequential strategy | Patients for whom anti-PD-1 therapy was stopped with the introduction of a new treatment line (19 patients, 63%). Receives: Biological: Evaluate the improvement in response from the end of anti-PD-1 monotherapy | |
| Group 2 Concomitant strategy | Patients for whom a combination of CT with anti-PD-1 therapy was initiated (11 patients, 37 %). Receives: Biological: Evaluate the improvement in response from the end of anti-PD-1 monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate after re-exposure to chemotherapy
Patient evaluation was timed by treating physicians according to the policy of each center, and all patients were evaluated after a median of 10 weeks (min 7 weeks, max 12 weeks) with PET/CT using Lugano criteria
Measured: 10 weeks
Secondary outcomes (5)
Best response obtained (Group 1)
the best response obtained with CT after anti-PD-1
Measured: 10 weeks
Best response obtained (Group 2)
the best response obtained with CT after the combination anti-PD-1 and CT
Measured: 10 weeks
The toxicities experienced during CT or anti-PD-1 plus CT combination
The toxicities were graded retrospectively according to the National Cancer Institute Common Toxicity Criteria for AEs (version 4.0).
Measured: 10 weeks
Outcomes including PFS
PFS was defined as the time from first relapse, or progression, to the next event (defined as either second relapse/progression, change of therapy, or death from any cause)
Measured: up to 12 months
Outcomes including overall survival (OS).
OS was defined as the time from first relapse, or progression, to death from any cause.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start31 Jan 2018
- Primary completion31 Jan 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé GHESQUIERES, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664323
- Sponsor's protocol ID
- Anti-PD-1 Hodgkin
- Status last verified
- Sep 2018
- First submitted
- 4 Jun 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chemotherapy or Chemo-anti-PD-1 Combination After Failed Anti-PD-1 Therapy for Relapsed and Refractory Hodgkin Lymphoma: a Series From Lysa Centers.
- ClinicalTrials.gov ID
- NCT03664323
- Acronym / sponsor ID
- Anti-PD-1 Hodgkin
- Conditions
- Hodgkin Lymphoma
- Keywords
- Immunotherapy, chemotherapy, anti-PD1, re-sensibilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 10 Sep 2018 (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.
Anti-PD-1 therapy provides high response rates in Hodgkin lymphoma (HL) patients who have relapsed or are refractory (R/R) to autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV), but median progression free survival (PFS) is only one year. The efficacy of treatment following anti-PD-1 is not well known.
In this context, the optimal treatment for patients who failed after anti-PD-1 therapy is an issue. To better assess their outcome, the investigators retrospectively analyzed the characteristics and outcome of patients from 14 LYSA (The Lymphoma Study Association) centers who lost response to anti-PD-1 therapy and received additional CT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Sequential strategy | – | Biological: Evaluate the improvement in response from the end of anti-PD-1 monotherapyPatients for whom anti-PD-1 therapy was stopped with the introduction of a new treatment line (19 patients, 63%). |
| Group 2 Concomitant strategy | – | Biological: Evaluate the improvement in response from the end of anti-PD-1 monotherapyPatients for whom a combination of CT with anti-PD-1 therapy was initiated (11 patients, 37 %). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The initial diagnosis of classical HL was established from biopsies in accordance with the 2008 World Health Organization classification14. We retrospectively analyzed 30 R/R classical HL patients from 14 LYSA centers who received anti-PD-1 therapy as part of a clinical trial (n=4), from an off-label program authorization for temporary use (ATU) from the French medical drug agency (Agence Nationale de Sécurité du Médicament, ANSM) (n=22), from the Belgian national system for the reimbursement of health care (Institut National d'Assurance Maladie Invalidité, INAMI) (n=4).
Key inclusion criteria (6 listed)
- Initial diagnosis of classical HL
- Optional histopathology confirmation of relapse/refractory HL, (2) age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 to 2
- Patients must be have received: at least 2 prior regimens and have received or be ineligible for autologous stem cell transplant and must have received prior BV, and at least 2 cycles of single agent anti-PD-1 as last treatment before entering the study,
- Patients must have inadequate response to anti-PD-1 monotherapy (progressive disease or partial response according to Lugano criteria) with at least one hypermetabolic lesion over the liver and mediastinum background at time of inclusion in the study
Key exclusion criteria (1 listed)
- radiotherapy in the treatment after anti-PD1
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 |
|---|---|---|
| Evaluate the improvement in response from the end of anti-PD-1 monotherapyEvaluate the improvement in response from the end of anti-PD-1 monotherapy to the first evaluation after introduction of CT alone (Group 1) or combined with anti-PD-1 (Group 2). | Biological | Group 1 Sequential strategy, Group 2 Concomitant strategy |
Primary outcome
Overall response rate after re-exposure to chemotherapy
Time frame: 10 weeks
Patient evaluation was timed by treating physicians according to the policy of each center, and all patients were evaluated after a median of 10 weeks (min 7 weeks, max 12 weeks) with PET/CT using Lugano criteria
5 secondary outcomes
Best response obtained (Group 1)
Time frame: 10 weeks
Best response obtained (Group 2)
Time frame: 10 weeks
The toxicities experienced during CT or anti-PD-1 plus CT combination
Time frame: 10 weeks
Outcomes including PFS
Time frame: up to 12 months
Outcomes including overall survival (OS).
Time frame: up to 24 months
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 10 Sep 2018.
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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.
Hervé GHESQUIERES, MD principal investigator
Hospices Civils de Lyon
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 Hodgkin Lymphoma, run by Hospices Civils de Lyon at 1 site in France.
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 6 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 10 Sep 2018. 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 France. 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 response rate after re-exposure to chemotherapy (time frame: 10 weeks). 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 10 Sep 2018.