Lymphoma, Large B-Cell, DiffusePhase 2Bio-CHICNCT03293173
Biomarker Driven Intensified ChemoImmunotherapy With Early CNS Prophylaxis
A Phase 2 study testing R-CHOEP and DA-EPOCH-R in people with Lymphoma, Large B-Cell, Diffuse, run by Nordic Lymphoma Group at 16 sites in 4 countries.
Trial summary
This study is testing whether stratification of the patients according to biological risk factors for different treatment groups will improve the outcome of patients with clinically high diffuse large B-cell lymphoma (DLBCL). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- R-CHOEP and DA-EPOCH-R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 16 sitesin 4 countries
- Study dates
- 4 Aug 2017to 31 Dec 2024
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 - 64 years
- Histologically confirmed CD20+ DLBCL based on revised WHO 2008 Lymphoma Classification. The following subgroups and variants can be included:
- ALK-positive large B-cell lymphoma
- Intravascular large B-cell lymphoma
- T-cell rich B-cell lymphoma
- Myc/BCL-2 double hit lymphoma
Show all 21Show fewer
- Follicular lymphomas grade 3b
- DLBCL with previously undiagnosed concurrent small cell infiltration in bone marrow, lymph node, or extranodal site and lymphomas intermediate between DLBCL and Burkitt's lymphoma are allowed
- Posttransplantation lymphoma (PTLD), discordant or transformed lymphoma are NOT allowed
- Patients in at least stage II with age adjusted IPI score of 2 or 3:
- Stage III /IV and elevated LDH
- Stage III/IV and WHO performance status 2 - 3
- Stage II and elevated LDH and WHO performance status 2 - 3
- And/or patients with site specific risk factors for CNS recurrence defined as follows
- More than one extranodal site
- Testicular lymphoma, stage IIE and higher
- Paranasal sinus and orbital lymphoma with destruction of bone
- Large cell lymphoma infiltration of the bone marrow
- Previously untreated, except steroids allowed
- WHO performance status 0-3
- Written informed consent
Who cannot join
- Severe cardiac disease: cardiac function grade 3-4, left ventricular ejection fraction <45%
- Impaired bone marrow liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule (Hemoglobin < 9 g/dL, ANC < 1.5 × 109/L, Platelet count < 75 × 109/L, creatinine clearance < 40 mL/min, ALT/AST > 2.5 x ULN, bilirubin 1.5 x ULN, INR > 1.5)
- Pregnancy/lactation
- Men and women of reproductive potential not agreeing to use effective contraception during treatment and for 18 months after completion of treatment (Effective contraception is combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), hormone-releasing IUD, bilateral tubal occlusion, vasectomised partner, or sexual abstinence
- Patients with other severe medical problems, including active infections, cardiac or pulmonary disease, history of PML and with an expected short survival for non-lymphoma reasons
- Known HIV positivity
Show all 21Show fewer
- Active or chronic hepatitis B virus (HBV) infection (defined as positive HBsAg serology), or active hepatitis C virus (HCV) infection (defined by antibody serology testing). HBsAg, HBcAb, and HCVAb must be tested during screening. Patients who have protective titers of HBsAb along negative HBsAg after vaccination or prior but cured hepatitis B are eligible.
- Vaccination with a live vaccine within one month prior to randomization
- Patients with a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for ≥ 5 years prior to enrollment
- Earlier treatment containing anthracyclines
- Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol
- CNS disease as diagnosed by MRI or CSF cytology. Positive CSF flow cytometry below diagnostic threshold level by cytology is allowed
- Transformed lymphoma
- Primary mediastinal B-cell lymphoma
- Pleural or peritoneal fluid that cannot be drained safely
- Hypersensitivity to the active substance or any of the other ingredients
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- Patients participating in other clinical studies, unless followed for survival
- Lower urinary tract constriction, which cannot be treated adequately
- Degenerative and toxic encephalopathy
- Neuromuscular disease
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Denmark5 sites
Aarhus University Hospital
Aarhus
Dept of Haematology, Rigshospitalet
Copenhagen, 2100
Dept of Haematology, Herlev Hospital, Copenhagen
Herlev
Dept haematology, Odense University hospital
Odense, 5000
Dept of Haematology, Sjaellands University hospital, Roskilde
Roskilde, 4000
Finland5 sites
Helsinki University Hospital Cancer Centre
Helsinki, 00029
Keski-Suomen keskussairaala
Jyväskylä, 40620
Kuopio University Hospital
Kuopio, 70029
TAYS
Tampere, 33521
Turku University Hospital, Syöpäklinikka
Turku, 20520
Norway5 sites
Dept. of Oncology, Helse Bergen HF Haukeland sykehus
Bergen, 5021
Oslo University Hospital
Oslo
Dept. of Haematology and Oncology, Helse Stavander HF sykehuset
Stavanger, 4011
Dept. of Oncology, Universitetssykehuset i Nord-Norge HF
Tromsø, 9038
Dept of Oncology, St. Olavs hospital HF
Trondheim, 7006
About this study
Official title: Biomarker Driven and Dose Intensified Chemoimmunotherapy With Early CNS Prophylaxis in Patients Less Than 65 Years With High Risk Diffuse Large B-Cell Lymphoma
This study is testing whether stratification of the patients according to biological risk factors for different treatment groups will improve the outcome of patients with clinically high diffuse large B-cell lymphoma (DLBCL).
Read the detailed description
For young clinically high-risk diffuse large B-cell lymphoma (DLBCL) patients the optimal therapy has not been established. Previous Nordic phase II studies, where dose-dense chemoimmunotherapy (R-CHOEP-14) with systemic CNS prophylaxis (HD-Mtx and HD-AraC) was given, demonstrated favorable outcome in comparison to historical controls. However, the patients with biological risk factors, such as translocation of bcl2 and myc oncogenes or and/or high BCL2 and MYC expression or deletion 17p and/or high P53 expression had significantly higher risk of death, as compared to patients without aberrations. The figures provide evidence for an unmet clinical need for the patients with biological risk factors, and underscore the importance of a clinical trial, where both biological and clinical risk factors play a role in the treatment planning.
In this trial treatment intensity varies according to presence or absence of biological risk factors. All patients receive a prephase medication consisting of prednisone and vincristine and two cycles of R-CHOP and high dose (HD) methotrexate. Subsequently, depending on the biological risk factors either four additional cycles of R-CHOEP (standard arm with no risk factors) or four dose adjusted R-EPOCH courses (experimental arm with risk factors) are given, followed by one course of high dose cytarabine (Ara-C) and R. R-CHOEP courses should be given with a two-week and R-EPOCH with a three-week interval.
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Being tested
- R-CHOEP, DA-EPOCH-R
- Keywords
- DLBCL, Chemoimmunotherapy, High risk, CNS prophylaxis, Biomarker-driven
- 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.
R-CHOEPCombination product
rituximab, cyclophosphamide, doxorubicin, etoposide, vincristine, prednisone
DA-EPOCH-RCombination product
dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Biologically low risk group, R-CHOEP-14 Receives: Combination Product: R-CHOEP |
| Group B | Experimental | Biologically high risk group, DA-EPOCH-R Receives: Combination Product: DA-EPOCH-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure (TTF) of the patients with biological risk factors
Interval between the registration date and the date of documented progression or lack of response, first relapse, death for any reason or discontinuation/change of therapy because of toxicity, whichever occurs first. Otherwise, patients will be censored at the last date they were known to be alive. For patients not responding at any time point on study treatment, TTF is defined as one day.
Measured: At 3 years
Secondary outcomes (7)
Time to treatment failure (TTF) at 3 years from date of registration of all patients and the patients in the low risk group
Interval between the registration date and the date of documented progression or lack of response, first relapse, death for any reason or discontinuation/change of therapy because of toxicity, whichever occurs first. Otherwise, patients will be censored at the last date they were known to be alive. For patients not responding at any time point on study treatment, TTF is defined as one day.
Measured: At 3 years
Incidence of treatment-emergent adverse events (Safety and tolerability)
Number of patients with treatment-related adverse events graded according to the NCI CTCAE v 4.03
Measured: During the treatment period at the end of each cycle (14 or 21 days) up to 6 months. In addition, severe late toxicities during follow-up at 6 months intervals through study completion, an average of 5.5 years.
Clinical response rate of all patients and the patients with biological risk factors
Number of patients with complete or partial response
Measured: At the end of treatment cycles 2 and 7. Each cycle is two (group A) or three weeks (group B)
CNS relapse rate
Number of patients with CNS progression
Measured: At 1,5 years
Progression free survival rate (PFS) of all patients and the patients with biological risk factors
Measured: At 3 years
Overall survival rate (OS) of all patients and the patients with biological risk factors
Measured: At 3 years
Molecular correlates for survival
Identification of genomic aberrations (for example mutations and translocations), gene expression profiles and protein expression from the tumor tissue and circulation that predict clinical course of the disease
Measured: At 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start4 Aug 2017
- Primary completion31 Jan 2021
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Stratification into group A (standard) or group B (experimental) based on biological risk factors
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordic Lymphoma Group
- Sponsor type
- Research network
- Collaborators
- Helsinki University Central Hospital, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Sirpa Leppa, prof, Principal investigator, Helsinki University Hospital Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293173
- Sponsor's protocol ID
- NLG-LBC-06
- Acronym
- Bio-CHIC
- Status last verified
- Jun 2024
- First submitted
- 5 Sep 2017
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual deidentified participant data (including data dictionaries) will be shared
Publications
Fiskvik I, Beiske K, Delabie J, Yri O, Spetalen S, Karjalainen-Lindsberg ML, Leppa S, Liestol K, Smeland EB, Holte H. Combining MYC, BCL2 and TP53 gene and protein expression alterations improves risk stratification in diffuse large B-cell lymphoma. Leuk Lymphoma. 2015 Jun;56(6):1742-9. doi: 10.3109/10428194.2014.970550. Epub 2014 Nov 19.
PubMed 25284491Holte H, Leppa S, Bjorkholm M, Fluge O, Jyrkkio S, Delabie J, Sundstrom C, Karjalainen-Lindsberg ML, Erlanson M, Kolstad A, Fossa A, Ostenstad B, Lofvenberg E, Nordstrom M, Janes R, Pedersen LM, Anderson H, Jerkeman M, Eriksson M. Dose-densified chemoimmunotherapy followed by systemic central nervous system prophylaxis for younger high-risk diffuse large B-cell/follicular grade 3 lymphoma patients: results of a phase II Nordic Lymphoma Group study. Ann Oncol. 2013 May;24(5):1385-92. doi: 10.1093/annonc/mds621. Epub 2012 Dec 17.
PubMed 23247661Arffman M, Meriranta L, Autio M, Holte H, Jorgensen J, Brown P, Jyrkkio S, Jerkeman M, Drott K, Fluge O, Bjorkholm M, Karjalainen-Lindsberg ML, Beiske K, Pedersen MO, Leivonen SK, Leppa S. Inflammatory and subtype-dependent serum protein signatures predict survival beyond the ctDNA in aggressive B cell lymphomas. Med. 2024 Jun 14;5(6):583-602.e5. doi: 10.1016/j.medj.2024.03.007. Epub 2024 Apr 4.
PubMed 38579729
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Driven and Dose Intensified Chemoimmunotherapy With Early CNS Prophylaxis in Patients Less Than 65 Years With High Risk Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03293173
- Acronym / sponsor ID
- Bio-CHIC / NLG-LBC-06
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Keywords
- DLBCL, Chemoimmunotherapy, High risk, CNS prophylaxis, Biomarker-driven
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nordic Lymphoma GroupResearch network
- Collaborators
- Helsinki University Central Hospital, Aarhus University Hospital
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Sep 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.
This study is testing whether stratification of the patients according to biological risk factors for different treatment groups will improve the outcome of patients with clinically high diffuse large B-cell lymphoma (DLBCL).
Detailed description
For young clinically high-risk diffuse large B-cell lymphoma (DLBCL) patients the optimal therapy has not been established. Previous Nordic phase II studies, where dose-dense chemoimmunotherapy (R-CHOEP-14) with systemic CNS prophylaxis (HD-Mtx and HD-AraC) was given, demonstrated favorable outcome in comparison to historical controls. However, the patients with biological risk factors, such as translocation of bcl2 and myc oncogenes or and/or high BCL2 and MYC expression or deletion 17p and/or high P53 expression had significantly higher risk of death, as compared to patients without aberrations. The figures provide evidence for an unmet clinical need for the patients with biological risk factors, and underscore the importance of a clinical trial, where both biological and clinical risk factors play a role in the treatment planning.
In this trial treatment intensity varies according to presence or absence of biological risk factors. All patients receive a prephase medication consisting of prednisone and vincristine and two cycles of R-CHOP and high dose (HD) methotrexate. Subsequently, depending on the biological risk factors either four additional cycles of R-CHOEP (standard arm with no risk factors) or four dose adjusted R-EPOCH courses (experimental arm with risk factors) are given, followed by one course of high dose cytarabine (Ara-C) and R. R-CHOEP courses should be given with a two-week and R-EPOCH with a three-week interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stratification into group A (standard) or group B (experimental) based on biological risk factors
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Combination Product: R-CHOEPBiologically low risk group, R-CHOEP-14 |
| Group B | Experimental | Combination Product: DA-EPOCH-RBiologically high risk group, DA-EPOCH-R |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Age 18 - 64 years
- Histologically confirmed CD20+ DLBCL based on revised WHO 2008 Lymphoma Classification. The following subgroups and variants can be included:
- Patients in at least stage II with age adjusted IPI score of 2 or 3:
- And/or patients with site specific risk factors for CNS recurrence defined as follows
- Previously untreated, except steroids allowed
Key exclusion criteria (21 listed)
- Severe cardiac disease: cardiac function grade 3-4, left ventricular ejection fraction <45%
- Impaired bone marrow liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule (Hemoglobin < 9 g/dL, ANC < 1.5 × 109/L, Platelet count < 75 × 109/L, creatinine clearance < 40 mL/min, ALT/AST > 2.5 x ULN, bilirubin 1.5 x ULN, INR > 1.5)
- Pregnancy/lactation
- Men and women of reproductive potential not agreeing to use effective contraception during treatment and for 18 months after completion of treatment (Effective contraception is combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), hormone-releasing IUD, bilateral tubal occlusion, vasectomised partner, or sexual abstinence
- Patients with other severe medical problems, including active infections, cardiac or pulmonary disease, history of PML and with an expected short survival for non-lymphoma reasons
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 |
|---|---|---|
| R-CHOEPrituximab, cyclophosphamide, doxorubicin, etoposide, vincristine, prednisone | Combination product | Group A |
| DA-EPOCH-Rdose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab | Combination product | Group B |
Primary outcome
Time to treatment failure (TTF) of the patients with biological risk factors
Time frame: At 3 years
Interval between the registration date and the date of documented progression or lack of response, first relapse, death for any reason or discontinuation/change of therapy because of toxicity, whichever occurs first. Otherwise, patients will be censored at the last date they were known to be alive. For patients not responding at any time point on study treatment, TTF is defined as one day.
7 secondary outcomes
Time to treatment failure (TTF) at 3 years from date of registration of all patients and the patients in the low risk group
Time frame: At 3 years
Incidence of treatment-emergent adverse events (Safety and tolerability)
Time frame: During the treatment period at the end of each cycle (14 or 21 days) up to 6 months. In addition, severe late toxicities during follow-up at 6 months intervals through study completion, an average of 5.5 years.
Clinical response rate of all patients and the patients with biological risk factors
Time frame: At the end of treatment cycles 2 and 7. Each cycle is two (group A) or three weeks (group B)
CNS relapse rate
Time frame: At 1,5 years
Progression free survival rate (PFS) of all patients and the patients with biological risk factors
Time frame: At 3 years
Overall survival rate (OS) of all patients and the patients with biological risk factors
Time frame: At 3 years
Molecular correlates for survival
Time frame: At 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Background: PubMed 25284491Fiskvik I, Beiske K, Delabie J, Yri O, Spetalen S, Karjalainen-Lindsberg ML, Leppa S, Liestol K, Smeland EB, Holte H. Combining MYC, BCL2 and TP53 gene and protein expression alterations improves risk stratification in diffuse large B-cell lymphoma. Leuk Lymphoma. 2015 Jun;56(6):1742-9. doi: 10.3109/10428194.2014.970550. Epub 2014 Nov 19.
- Background: PubMed 23247661Holte H, Leppa S, Bjorkholm M, Fluge O, Jyrkkio S, Delabie J, Sundstrom C, Karjalainen-Lindsberg ML, Erlanson M, Kolstad A, Fossa A, Ostenstad B, Lofvenberg E, Nordstrom M, Janes R, Pedersen LM, Anderson H, Jerkeman M, Eriksson M. Dose-densified chemoimmunotherapy followed by systemic central nervous system prophylaxis for younger high-risk diffuse large B-cell/follicular grade 3 lymphoma patients: results of a phase II Nordic Lymphoma Group study. Ann Oncol. 2013 May;24(5):1385-92. doi: 10.1093/annonc/mds621. Epub 2012 Dec 17.
- Derived from this study: PubMed 38579729Arffman M, Meriranta L, Autio M, Holte H, Jorgensen J, Brown P, Jyrkkio S, Jerkeman M, Drott K, Fluge O, Bjorkholm M, Karjalainen-Lindsberg ML, Beiske K, Pedersen MO, Leivonen SK, Leppa S. Inflammatory and subtype-dependent serum protein signatures predict survival beyond the ctDNA in aggressive B cell lymphomas. Med. 2024 Jun 14;5(6):583-602.e5. doi: 10.1016/j.medj.2024.03.007. Epub 2024 Apr 4.
- Individual participant dataSharing planned: Yes. individual deidentified participant data (including data dictionaries) will be shared
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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.
Sirpa Leppa, prof principal investigator
Helsinki University Hospital Cancer Centre
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-CHOEP and DA-EPOCH-R in people with Lymphoma, Large B-Cell, Diffuse, run by Nordic Lymphoma Group at 16 sites in 4 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 21 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Denmark, Finland, Norway, Sweden. 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?
Results are not available in the source record.
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?
Time to treatment failure (TTF) of the patients with biological risk factors (time frame: At 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03293173, which also lists 3 linked publications.
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 21 Jun 2024.