Diffuse Large B Cell LymphomaPhase 2ILIADNCT03576443
Trial of Idelalisib in Patients With Relapsed Diffuse Large B-cell Lymphoma
A Phase 2 study testing Idelalisib in people with Diffuse Large B Cell Lymphoma, run by Nordic Lymphoma Group at 6 sites in 2 countries.
Trial summary
Based on the high response rate in heavily pretreated patients with indolent B-cell lymphomas, among which it is likely that many have undetected transformed disease, the investigators hypothesize that idelalisib may also be active in relapsed DLBCL, particularly of the GCB subtype. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Idelalisib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 7 Jul 2017to 30 Sep 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years.
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL) , including transformed low grade lymphoma, with either:
- Refractory disease: defined as disease progression while receiving their most recent prior cytotoxic chemotherapy (single-agent immunotherapy as maintenance is not considered cytotoxic therapy).
- Persistent disease: defined as stable disease or partial response at the completion of their most recent prior cytotoxic chemotherapy.
- Relapsed/recurrent disease: defined as complete response at the end of their most recent prior cytotoxic chemotherapy with subsequent relapse or disease recurrence.
- Subjects must have received prior rituximab and may have received up to 5 prior regimens containing cytotoxic chemotherapies.
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- Subjects must not be candidates for high-dose chemotherapy with autologous stem cell support (ASCT), due to one or more of the following factors: relapse after high dose chemotherapy, age, comorbid disease, performance status, or persisting toxicities from prior chemotherapy.
- Absolute neutrophil count (ANC) >1.0 x 109/L, unless related to bone marrow infiltration.
- At least 1 measurable disease lesion that is >1.0 cm in 2 perpendicular dimensions, with the product diameter >2.25 cm2 by computed tomography (CT) or magnetic resonance imaging (MRI).
- Negative serum pregnancy test within 1 week before first treatment if the subject is a woman of childbearing potential. The use of highly-effective contraception methods* are required during the study for women of child-bearing potential. Due to the toxicity of idelalisib, women who will use a hormonal contraceptive must in addition also use a barrier method, since it is currently unknown whether idelalisib may reduce the effectiveness of hormonal contraceptives. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
- WHO performance status 0 - 3.
- Written informed consent.
Who cannot join
- Prior allogeneic hematopoietic stem cell transplant (HSCT).
- Prior treatment with PI3K inhibitors.
- Serum total bilirubin ≥ 1.5 x ULN (unless elevated due to Gilbert's syndrome).
- Serum ALT and AST ˃ 2.5 x ULN.
- Estimated Creatinine Clearance < 10 ml/min.
- Known seropositivity for human immunodeficiency virus (HIV).
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- Known history of drug induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, on-going extra-hepatic obstruction caused by cholelithiasis, cirrhosis of the liver or portal hypertension.
- Known history of drug induced pneumonitis.
- On-going inflammatory bowel disease.
- Evidence of serious active infection (eg, requiring an intravenous [IV] antibiotic, antiviral, or antifungal agent), or subjects with a recent history of deep tissue infections such as fascitis or osteomyelitis.
- Chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational drugs/devices <10 days before first dose of investigational product in this study. Subjects receiving high doses of corticosteroids must have been tapered to a stable dose at least 7 days before the first dose of investigational product.
- Pregnant or breastfeeding women.
- Symptomatic central nervous system (CNS) NHL; a lumbar puncture is not required unless CNS involvement with NHL is clinically suspected.
- Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition).
- Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for >2 years.
- Previous myocardial infarction or pulmonary hypertension <6 months before first dose of investigational product.
- History of clinically significant ventricular arrhythmia, prolonged QTc interval or unexplained syncope.
- Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Sweden4 sites
Halmstad County Hospital
Halmstad, 30 233
Linkoping University Hospital
Linköping, 581 85
Skane University Hospital
Lund, 221 85
Karolinska University Hospital
Stockholm, 141 86
Denmark2 sites
Aarhus University Hospital
Aarhus C, 8000
Odense University Hospital
Odense
About this study
Official title: A Phase II Trial of Idelalisib in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Based on the high response rate in heavily pretreated patients with indolent B-cell lymphomas, among which it is likely that many have undetected transformed disease, the investigators hypothesize that idelalisib may also be active in relapsed DLBCL, particularly of the GCB subtype. Possibly, the efficacy may be related to the presence of specific mutations within the B-cell receptor pathway.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Idelalisib
- 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.
IdelalisibDrug
Idelalisib 150 mg x 2 p o
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Idelalisib 150 mg x 2 p o, until progression Receives: Drug: Idelalisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate for GCB DLBCL
Overall response rate (ORR) for GCB DLBCL
Measured: at time of progression, up to 112 weeks from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start7 Jul 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Lymphoma Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Mats Jerkeman, Principal investigator, Department of Oncology Skåne University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576443
- Sponsor's protocol ID
- NLG-LBC-07
- Acronym
- ILIAD
- Status last verified
- Oct 2021
- First submitted
- 30 Apr 2018
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Idelalisib in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT03576443
- Acronym / sponsor ID
- ILIAD / NLG-LBC-07
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Nordic Lymphoma GroupResearch network
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 3 Jul 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.
Based on the high response rate in heavily pretreated patients with indolent B-cell lymphomas, among which it is likely that many have undetected transformed disease, the investigators hypothesize that idelalisib may also be active in relapsed DLBCL, particularly of the GCB subtype. Possibly, the efficacy may be related to the presence of specific mutations within the B-cell receptor pathway.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: IdelalisibIdelalisib 150 mg x 2 p o, until progression |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age >18 years.
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL) , including transformed low grade lymphoma, with either:
- Subjects must have received prior rituximab and may have received up to 5 prior regimens containing cytotoxic chemotherapies.
- Subjects must not be candidates for high-dose chemotherapy with autologous stem cell support (ASCT), due to one or more of the following factors: relapse after high dose chemotherapy, age, comorbid disease, performance status, or persisting toxicities from prior chemotherapy.
- Absolute neutrophil count (ANC) >1.0 x 109/L, unless related to bone marrow infiltration.
Key exclusion criteria (18 listed)
- Prior allogeneic hematopoietic stem cell transplant (HSCT).
- Prior treatment with PI3K inhibitors.
- Serum total bilirubin ≥ 1.5 x ULN (unless elevated due to Gilbert's syndrome).
- Serum ALT and AST ˃ 2.5 x ULN.
- Estimated Creatinine Clearance < 10 ml/min.
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 |
|---|---|---|
| IdelalisibIdelalisib 150 mg x 2 p o | Drug | Treatment arm |
Primary outcome
Overall response rate for GCB DLBCL
Time frame: at time of progression, up to 112 weeks from start of treatment
Overall response rate (ORR) for GCB DLBCL
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 13 Oct 2021.
- 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.
Mats Jerkeman principal investigator
Department of Oncology Skåne University Hospital
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Idelalisib in people with Diffuse Large B Cell Lymphoma, run by Nordic Lymphoma Group at 6 sites in 2 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 18 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 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden, Denmark. 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 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 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 for GCB DLBCL (time frame: at time of progression, up to 112 weeks from start of treatment). 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 13 Oct 2021.