Lymphoma, Large B-Cell, DiffusePhase 2IDA-DNCT03241017
Durvalumab in DLBCL After Autologous Transplant
A Phase 2 study testing Durvalumab in people with Lymphoma, Large B-Cell, Diffuse, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
The trial assess the progression-free survival (PFS) two years after autologous stem cell transplantation (ASCT) in high-risk DLBCL patients receiving PD-L1 inhibition with durvalumab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- Durvalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Dec 2021
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with any types of DLBCL (de novo or transformed), including double-hit lymphomas, grey zone lymphomas, double or triple expressor lymphomas, unclassifiable aggressive lymphoma types or aggressive lymphomas.
- Lymphoma patients (as listed above) in first remission considered as high-risk and defined as lymphoma patients not achieving a complete first remission after induction treatment before subsequent ASCT; or patients in second remission considered as high-risk and defined as lymphoma patients relapsing within 12 months after first-line treatment or lymphoma patients not achieving a complete second remission after salvage treatment before subsequent ASCT.
- ECOG 0-2
- Age 18-75 years
- Female patients of child-bearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to study treatment, and they must implement adequate measures (hormonal treatment p.o. or i.m., intra uterine surgical devices, or latex condoms) to avoid pregnancy during study treatment and for additional 12 months.
- Patients must have given voluntary written informed consent.
Who cannot join
- Other types of malignant lymphomas
- Previous treatment with antibodies against PD-(L)1
- Symptomatic CNS (Central Nervous System) involvement by lymphoma
- Active infection requiring antibiotic/antifungal treatment
- Lack of patient cooperation to allow study treatment as outlined in this protocol
- Pregnancy or lactating female patients
- Major surgery less than 30 days before start of treatment
- Contraindications and hypersensitivity to any of the active chemotherapy compounds
About this study
Official title: A Phase II Trial Investigating the Benefit of Immunotherapy With Durvalumab After Autologous Transplant in High-risk Diffuse-large B-cell Lymphomas (the IDA-D Trial)
The trial assess the progression-free survival (PFS) two years after autologous stem cell transplantation (ASCT) in high-risk DLBCL patients receiving PD-L1 inhibition with durvalumab.
Read the detailed description
Background and Rationale:
Autologous stem cell transplantation (ASCT) is standard of care in the treatment concept of adult patients with multiple myeloma (MM), malignant lymphomas (including diffuse large B-cell lymphomas (DLBCL), mantle cell lymphomas, follicular lymphomas or T-cell lymphomas), acute myeloid leukemia (AML) and relapsing germ cell tumors. The number of patients treated with ASCT is steadily increasing, e.g. by +17% alone in Switzerland in the year 2015, to a total of 464 ASCT per year in Switzerland. The Inselspital (University Hospital) in Berne is the leading hospital in Switzerland for ASCT, with 145 ASCT in the year 2015. Among these 145 transplants, 31 patients had DLBCL.
The goal of treatment in DLBCL is definite cure. In DLBCL, the addition of anti-CD20 treatment to standard CHOP (Cyclophosphamid, Doxorubicin, Vincristine, Prednisone) chemotherapy has improved the cure rate after R-CHOP (Rituximab-CHOP) first-line treatment. Nevertheless, the disease is relapsing in roughly 20% of these patients. At relapse, patients are treated with salvage chemotherapy such as the R-DHAP (Rituximab, Dexamethasone, Cisplatin,Cytarabine), or R-ICE (Rituximab,Ifosfamide, Carboplatin, Etoposide) regimens, followed by BEAM (BCNU, Etoposide, Cytarabine, Melphalan) or BeEAM (Bendamustin, Etoposide, Cyclophosphamide, Melphalan) high-dose chemotherapy supported with ASCT. The overall survival rate at the Inselspital Bern and elsewhere at two years for DLBCL patients after ASCT is 60%, and, therefore, improving outcome of such patients remains an unmet clinical need. This is particularly true in high-risk DLBCL patients, such as in DLBCL patients relapsing within 12 months after first-line treatment as well as in DLBCL patients not achieving a (first or second) complete remission (CR) after induction treatment before ASCT. PFS at two years for such high-risk lymphoma patients is 50% at the investigators' institution.
Immunotherapy (such as with PD-L1 inhibition) after ASCT is a promising approach to potentially improve results after ASCT. A first study applying PD-1 inhibition with three applications (every 42 days) of Pidilizumab started between days 30 and 90 after ASCT showed a promising progression-free survival rate of 72% in relapsing DLBCL patients at 16 months after the first Pidilizumab application. These data suggest that immunotherapy after ASCT has the potential to a meaningful improvement of survival rates in DLBCL patients after ASCT.
Objective:
The primary objective of this Trial is to show a progression-free survival of 70% two years after autologous stem cell transplantation (ASCT) in high-risk DLBCL patients receiving PD-L1 inhibition with durvalumab.
Study Duration:
The 46 patients needed in this study will be included within 24 months. Additional 24 months will be needed until the last study patient reaches PFS at 2 years. Accordingly, the total study duration is expected to be 48 months.
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Being tested
- Durvalumab
- Keywords
- Diffuse Large B-Cell Lymphoma, Double-hit Lymphomas, Grey Zone Lymphomas, Double or Triple Expressor Lymphomas, Unclassifiable Aggressive Lymphoma types, Aggressive Lymphomas
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Immunotherapy with Durvalumab after ASCT
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab | Experimental | Durvalumab 1500 mg (day 1) given every 4 weeks for a total of 12 applications (1 year). Receives: Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Number of Patients with Progression-free survival (PFS) two years after autologous stem cell transplantation (ASCT) in high-risk DLBCL patients receiving PD-L1 inhibition with durvalumab.
Measured: 24 months
Secondary outcomes (5)
Response Rate
The Response (Tumor measurement) to durvalumab treatment will be assessed by PET-CT 24 months after ASCT
Measured: 24 months
Adverse Events
Number of Patients experiencing Toxicity (Adverse Events)
Measured: 24 months
Hematologic engraftment
Number of days until hematological engraftment. Hematologic engraftment after high-dose chemotherapy induced myelosuppression is defined as the first day of neutrophils rising again above 0.5 G/l, and of platelets rising again above 20 G/L in the absence of platelet transfusions in the previous 3 days. Hematological values will be performed every 4 weeks
Measured: 24 months
The quality of life
The EORTC Q30 questionnaire will be given to patients before the first durvalumab administration, and after 3, 12 and 24 months after ASCT to assess quality of life.
Measured: 24 months
Overall Survival
Number of Patient alive at 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study startOct 2017 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Celgene withdrew the support for this study (Durvalumab cannot be provided)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional, prospective, single-center, open-label, single-arm, non-comparative and non-randomized phase II study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Thomas Pabst, MD, Study chair, Departement of Medical Oncology, University Hospital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241017
- Sponsor's protocol ID
- IDA-D Trial
- Acronym
- IDA-D
- Status last verified
- Apr 2018
- First submitted
- 26 Jul 2017
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Investigating the Benefit of Immunotherapy With Durvalumab After Autologous Transplant in High-risk Diffuse-large B-cell Lymphomas (the IDA-D Trial)
- ClinicalTrials.gov ID
- NCT03241017
- Acronym / sponsor ID
- IDA-D / IDA-D Trial
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Keywords
- Diffuse Large B-Cell Lymphoma, Double-hit Lymphomas, Grey Zone Lymphomas, Double or Triple Expressor Lymphomas, Unclassifiable Aggressive Lymphoma types, Aggressive Lymphomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Celgene withdrew the support for this study (Durvalumab cannot be provided)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Oct 2017 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Aug 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.
The trial assess the progression-free survival (PFS) two years after autologous stem cell transplantation (ASCT) in high-risk DLBCL patients receiving PD-L1 inhibition with durvalumab.
Detailed description
Background and Rationale:
Autologous stem cell transplantation (ASCT) is standard of care in the treatment concept of adult patients with multiple myeloma (MM), malignant lymphomas (including diffuse large B-cell lymphomas (DLBCL), mantle cell lymphomas, follicular lymphomas or T-cell lymphomas), acute myeloid leukemia (AML) and relapsing germ cell tumors. The number of patients treated with ASCT is steadily increasing, e.g. by +17% alone in Switzerland in the year 2015, to a total of 464 ASCT per year in Switzerland. The Inselspital (University Hospital) in Berne is the leading hospital in Switzerland for ASCT, with 145 ASCT in the year 2015. Among these 145 transplants, 31 patients had DLBCL.
The goal of treatment in DLBCL is definite cure. In DLBCL, the addition of anti-CD20 treatment to standard CHOP (Cyclophosphamid, Doxorubicin, Vincristine, Prednisone) chemotherapy has improved the cure rate after R-CHOP (Rituximab-CHOP) first-line treatment. Nevertheless, the disease is relapsing in roughly 20% of these patients. At relapse, patients are treated with salvage chemotherapy such as the R-DHAP (Rituximab, Dexamethasone, Cisplatin,Cytarabine), or R-ICE (Rituximab,Ifosfamide, Carboplatin, Etoposide) regimens, followed by BEAM (BCNU, Etoposide, Cytarabine, Melphalan) or BeEAM (Bendamustin, Etoposide, Cyclophosphamide, Melphalan) high-dose chemotherapy supported with ASCT. The overall survival rate at the Inselspital Bern and elsewhere at two years for DLBCL patients after ASCT is 60%, and, therefore, improving outcome of such patients remains an unmet clinical need. This is particularly true in high-risk DLBCL patients, such as in DLBCL patients relapsing within 12 months after first-line treatment as well as in DLBCL patients not achieving a (first or second) complete remission (CR) after induction treatment before ASCT. PFS at two years for such high-risk lymphoma patients is 50% at the investigators' institution.
Immunotherapy (such as with PD-L1 inhibition) after ASCT is a promising approach to potentially improve results after ASCT. A first study applying PD-1 inhibition with three applications (every 42 days) of Pidilizumab started between days 30 and 90 after ASCT showed a promising progression-free survival rate of 72% in relapsing DLBCL patients at 16 months after the first Pidilizumab application. These data suggest that immunotherapy after ASCT has the potential to a meaningful improvement of survival rates in DLBCL patients after ASCT.
Objective:
The primary objective of this Trial is to show a progression-free survival of 70% two years after autologous stem cell transplantation (ASCT) in high-risk DLBCL patients receiving PD-L1 inhibition with durvalumab.
Study Duration:
The 46 patients needed in this study will be included within 24 months. Additional 24 months will be needed until the last study patient reaches PFS at 2 years. Accordingly, the total study duration is expected to be 48 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, prospective, single-center, open-label, single-arm, non-comparative and non-randomized phase II study
| Arm | Type | Receives |
|---|---|---|
| Durvalumab | Experimental | Drug: DurvalumabDurvalumab 1500 mg (day 1) given every 4 weeks for a total of 12 applications (1 year). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with any types of DLBCL (de novo or transformed), including double-hit lymphomas, grey zone lymphomas, double or triple expressor lymphomas, unclassifiable aggressive lymphoma types or aggressive lymphomas.
- Lymphoma patients (as listed above) in first remission considered as high-risk and defined as lymphoma patients not achieving a complete first remission after induction treatment before subsequent ASCT; or patients in second remission considered as high-risk and defined as lymphoma patients relapsing within 12 months after first-line treatment or lymphoma patients not achieving a complete second remission after salvage treatment before subsequent ASCT.
- ECOG 0-2
- Age 18-75 years
- Female patients of child-bearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to study treatment, and they must implement adequate measures (hormonal treatment p.o. or i.m., intra uterine surgical devices, or latex condoms) to avoid pregnancy during study treatment and for additional 12 months.
Key exclusion criteria (8 listed)
- Other types of malignant lymphomas
- Previous treatment with antibodies against PD-(L)1
- Symptomatic CNS (Central Nervous System) involvement by lymphoma
- Active infection requiring antibiotic/antifungal treatment
- Lack of patient cooperation to allow study treatment as outlined in this protocol
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 |
|---|---|---|
| DurvalumabImmunotherapy with Durvalumab after ASCT | Drug | Durvalumab |
Primary outcome
Progression-free survival
Time frame: 24 months
Number of Patients with Progression-free survival (PFS) two years after autologous stem cell transplantation (ASCT) in high-risk DLBCL patients receiving PD-L1 inhibition with durvalumab.
5 secondary outcomes
Response Rate
Time frame: 24 months
Adverse Events
Time frame: 24 months
Hematologic engraftment
Time frame: 24 months
The quality of life
Time frame: 24 months
Overall Survival
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 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.
Thomas Pabst, MD study chair
Departement of Medical Oncology, University Hospital Berne
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab in people with Lymphoma, Large B-Cell, Diffuse, run by Insel Gruppe AG, University Hospital Bern.
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 8 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: withdrawn, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression-free survival (time frame: 24 months). 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 9 Apr 2018.