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EBV Related Non-Hodgkin's LymphomaPhase 2DuRIANSNCT03212807

Study Of Durvalumab and Lenalidomide In R/R EBV Associated DLBCL Subtypes, Primary CNS And Testicular DLBCL

A Phase 2 study testing Durvalumab and Lenalidomide in people with EBV Related Non-Hodgkin's Lymphoma and Primary CNS Lymphoma, run by Singapore General Hospital at 4 sites in Singapore.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

PHASE II STUDY OF DURVALUMAB IN COMBINATION WITH LENALIDOMIDE IN RELAPSED/REFRACTORY EBV ASSOCIATED SUBTYPES OF DLBCL, PRIMARY CNS LYMPHOMA AND PRIMARY TESTICULAR DLBCL Patients with relapsed refractory subtypes of DLBCL who fulfill the inclusion / exclusion criteria will be recruited to this trial and treated in this… Read more about this study

Who is it for?
Ages 21 to 80 years
What is being tested?
Durvalumab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
4 sitesSingapore
Study dates
Aug 2017to Aug 2023
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 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be willing and able to provide written informed consent for the trial.
  • Be ≥ 21 years of age on the day of signing informed consent
  • Histologically proven relapsed / refractory DLBCL classified under the following WHO Subtypes.
  • i, EBV Positive DLBCL (of the elderly and immunosuppression associated) ii, T-cell / histiocyte-rich B-cell lymphoma iii, Plasmablastic lymphoma iv, Gray zone lymphoma v, Primary Mediastinal Large B-Cell Lymphoma vi, Primary CNS Lymphoma (DLBCL) vii, Primary testicular lymphoma The biopsy needs to have been obtained within 3 months of signing informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Patients must have received at least one course (1 - 6 cycles) of Immunochemotherapy for example Rituximab + Chemotherapy (CHOP or CHOP like) and must have relapsed or refractory disease at the time of trial entry.
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  • Patients should have been deemed ineligible or failed or refused an autologous stem cell transplant in situations where stem cell transplant is the accepted standard of care. In patients with chemo-refractory DLBCL, even if patient is suitable for ASCT, transplant is extremely unlikely to achieve a response and hence such patients can be recruited after careful consideration by the investigator in discussion with the treating physician.
  • Have measureable disease, defined as at least one lesion that can be accurately measured in at least two dimensions on a CT scan or MRI scan in PCNSL. Minimum measurement must be > 15 mm in the longest diameter by >10 mm in the short axis.
  • Minimum life expectancy of 3 months.
  • Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) within 30 days prior to signing informed consent, including:
  • Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
  • Platelet count ≥ 50 x 109/L
  • Hemoglobin ≥ 8 g/dL
  • Adequate other organ functions as defined in protocol.
  • Must be able to adhere to study visit schedules and other protocol requirements.
  • Females of childbearing potential must:
  • Have 2 negative pregnancy tests as verified by a Study Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the patient practices complete abstinence from heterosexual contact.
  • Either commit to complete abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption, 30 days prior to starting study drug, during the study therapy (including dose interruptions), and for 30 days after discontinuation of study therapy.
  • Male patients must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or female of childbearing potential while participating in the study, during dose interruptions and for 30 days after discontinuation of study therapy, even if he has undergone successful vasectomy.
  • All patients must:
  • Have an understanding that the study drug could have a potential teratogenic risk.
  • Agree to abstain from donating blood while taking study drug, during dose interruptions and for 30 days after discontinuation of study therapy.
  • Agree not to share study medication with another person.
  • Agree to be counseled about pregnancy precautions and risk of fetal exposure.
  • Females must agree to abstain from breast feeding during the study participation and for 30 days after discontinuation of study therapy.
  • Male subjects should not donate sperm or semen while on the study and during breaks (dose interruptions), and for at least 30 days after the last dose of the study medications.

Who cannot join

  • The presence of any of the following will exclude a patient from enrolment:
  • Concomitant use of any other investigational agent or device
  • Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxin, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Subjects who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of GVHD).
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e. ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. i) Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. ii) If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. iii) Toxicity that has not recovered to ≤ Grade 1 is allowed if it meets the inclusion requirements for laboratory parameters defined in points 8 \& 9 under inclusion criteria.
  • Patients who have had Intrathecal chemotherapy within 2 weeks of trial entry if it was given at the time of diagnostic lumbar puncture could still be included.
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  • Known infection with human immunodeficiency virus (HIV).
  • Patient has known clinically active hepatitis B; carriers of hepatitis B are permitted but need to be on appropriate anti-viral therapy or have regular hepatitis B DNA virus monitored as advised by a Gastroenterologist.
  • Neuropathy > Grade 2.
  • Patients who are at a high risk of a thromboembolic event and are not willing to take venous thromboembolic prophylaxis.
  • Myocardial infarction within 6 months prior to enrolment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
  • Clinically significant active infection needing intravenous systemic therapy or uncontrolled intercurrent illness.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Has evidence of active, non-infectious pneumonitis
  • Pregnant or lactating females.
  • Coexistent second malignancy or history of prior malignancy within the preceding 3 years (excluding non-melanoma skin tumors or in situ carcinoma of the cervix).
  • Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
  • Has received a live vaccine within 30 days prior to first dose.

Trial locations and contacts

4 sites in 1 country.

Singapore4 sites

  • National Cancer Center

    Singapore

  • National University Hospital

    Singapore

  • Raffles Hospital

    Singapore

  • Singapore General Hospital

    Singapore

Other trials in Singapore

About this study

Official title: Phase II Study Of Durvalumab In Combination With Lenalidomide In Relapsed/Refractory EBV Associated Subtypes Of DLBCL, Primary CNS Lymphoma And Primary Testicular DLBCL - DuRIANS (Durvalumab Revlimid In Aggressive NHL Subtypes)

PHASE II STUDY OF DURVALUMAB IN COMBINATION WITH LENALIDOMIDE IN RELAPSED/REFRACTORY EBV ASSOCIATED SUBTYPES OF DLBCL, PRIMARY CNS LYMPHOMA AND PRIMARY TESTICULAR DLBCL

Patients with relapsed refractory subtypes of DLBCL who fulfill the inclusion / exclusion criteria will be recruited to this trial and treated in this open label, phase 2 trial with the PDL1 inhibitor Durvalumab and Lenalidomide. The combination treatment will be given from the time of recruitment for 6 months when Lenalidomide will be stopped but Durvalumab will continue for a total of 2 years. Response will be assessed by PET / CT scans as per standard lugano criteria.

Read the detailed description

This is a multi-center, open-label, phase II study of Durvalumab in combination with Lenalidomide for treatment of relapsed/refractory EBV associated DLBCL subtypes, primary testicular lymphoma and primary CNS lymphoma using a Simon's Two-stage Minimax design. Simon's two-stage Minimax design will be used to investigate if the overall response rate (ORR) is at least 45% against a no-interest ORR of 20%.

In the first stage, 13 patients will be accrued. If there are 2 or fewer responses in these 13 patients, the study will be stopped. Otherwise, 8 additional patients will be accrued for a total of 21 patients.This design yields a type I error rate of 5% and power of 80% when the true response rate is 45%.

Keywords
Checkpoint inhibition, PDL1, EBV DLBCL, PCNSL

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03212807
Study groupRoleWhat they receive
InvestigationalExperimentalDurvalumab + Lenalidomide
Receives: Drug: Durvalumab; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Overall response rate (ORR) is defined as the proportion of patients with reduction in tumor burden of at least 50%. ORR will be reported with corresponding 95% confidence intervals using the exact binomial method.

    Measured: at least 6 months of follow up

Secondary outcomes (2)

  1. Progression free survival

    Progression-free survival (PFS) is defined as the time from enrolment to progression or death due to any cause.

    Measured: 12 months

  2. Overall Survival

    Overall survival (OS) is defined as the time from registration to death due to any cause.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2017
  2. Study startAug 2017 (estimated)
  3. Primary completionFeb 2021 (estimated)
  4. Study completionAug 2023 (estimated)

Why it stopped: FDA Hold for Combination Studies using Imids and PD1/PDL1 Compounds

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03212807
Sponsor's protocol ID
SDBCC-LYM-16-02
Acronym
DuRIANS
Status last verified
Sep 2018
First submitted
7 Jul 2017
Last updated
13 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab and Lenalidomide in people with EBV Related Non-Hodgkin's Lymphoma and Primary CNS Lymphoma, run by Singapore General Hospital at 4 sites in Singapore.

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 26 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: withdrawn, as of the sponsor's last update on 13 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 4 sites in Singapore. 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 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?

Overall Response Rate (time frame: at least 6 months of follow up). 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 NCT03212807.

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 Sep 2018.

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