AzTrials
AzTrials

LYMPHOMAPhase 2NCT03054532

Phase II Study of Durvalumab in Combination With Lenalidomide in Relapsed/Refractory NK-T-cell Lymphoma

A Phase 2 study testing Durvalumab and Lenali in people with LYMPHOMA, run by Singapore General Hospital at 4 sites in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a multi-center, open-label, phase II study of durvalumab in combination with lenalidomide for treatment of relapsed/refractory NK/T-cell lymphoma (NKTCL). The study will employ a 2-stage Simon Optimal design with 80% power and type 1 error rate (significance level) of 5%. Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
LYMPHOMA
What is being tested?
Durvalumab and Lenali
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
4 sitesSingapore
Study dates
Jul 2017to Jul 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 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven NK/T-cell lymphoma that has relapsed after at least one cycle of induction chemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Previously treated with at least one cycle of chemotherapy that includes L-asparaginase or gemcitabine.
  • Must be aged ≥ 21 years and able to sign informed consent form.
  • Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow or hemophagocytic syndrome related to NKL) within 30 days prior to signing informed consent, including:
  • Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
Show all 20Show fewer
  • Platelet count ≥ 50 x 109/L
  • Hemoglobin ≥ 8 g/dL
  • 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, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 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 28 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 28 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 28 days after discontinuation of study therapy.
  • Male subjects should not donate sperm or semen while taking lenalidomide, during breaks (dose interruptions), and for at least 28 days after the last dose of lenalidomide.

Who cannot join

  • Concomitant use of any other investigational agent.
  • 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.
  • Subject has a calculated or measured creatinine clearance of < 30 mL/minute.
  • Neuropathy > Grade 2.
  • Presence of CNS involvement by lymphoma.
Show all 11Show fewer
  • Myocardial infarction within 6 months prior to enrolment or has New York Hospital 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 or uncontrolled intercurrent illness.
  • 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.

Trial locations and contacts

4 sites in 1 country.

Colin Phipps, MD contact

6562223322

colin.phipps.diong@singhealth.com.sg

Singapore4 sites

  • National University Hospital Singapore

    Singapore, 119228

    Michelle Poon, MD, 6567795555, NUH_Enquiries@nuhs.edu.sg

  • Singapore General Hospital

    Singapore, 169608

    Colin Phipps, MD, 6562223322, colin.phipps.diong@singhealth.com.sg

  • National Cancer Centre Singapore

    Singapore, 169610

    Soon Thye Lim, MD, 6564368000, callcentre@nccs.com.sg

  • Raffles Hospital Singapore

    Singapore, 188770

    Daryl Tan, MD, 6563111111, enquiries@raffleshospital.com

Other trials in Singapore

About this study

This is a multi-center, open-label, phase II study of durvalumab in combination with lenalidomide for treatment of relapsed/refractory NK/T-cell lymphoma (NKTCL). The study will employ a 2-stage Simon Optimal design with 80% power and type 1 error rate (significance level) of 5%. Stage 1 will involve 8 patients and will require at least 2 patients to achieve the primary end point of overall response in order to proceed onto to stage 2, which will have a target enrolment of 14 patients.

Conditions
LYMPHOMA
Being tested
Durvalumab, Lenali
Medical subject headings
Lymphoma

What participants receive

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

  • DurvalumabDrug

    Durvalumab intravenous 1500 mg

  • LenaliDrug

    Lenalidomide oral 20 mg/day

Study groups in NCT03054532
Study groupRoleWhat they receive
Durvalumab and lenalidomideExperimentalOpen-label use of 2 drugs: * Durvalumab 1500 mg intravenously on day 1 of a 28-day cycle until progressive disease or intolerance. * Lenalidomide orally on days 1 through 21 of each 28-day cycle for 6 cycles.
Receives: Drug: Durvalumab; Drug: Lenali

What is being measured

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

  1. Efficacy as measured by overall response rate measured at the time of best response.

    Overall response rate (ORR) is defined as the proportion of patients with reduction in tumor burden of at least 50%.

    Measured: 2 years

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    PFS is defined as the time from enrolment to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.

    Measured: 2 years

  2. Overall survival (OS)

    OS is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Measured: 2 years

  3. Time-to-response (TTR)

    Defined for all evaluable patients who have achieved an overall response as the date at which the patient's objective status is first noted to be a CR or PR.

    Measured: 2 years

  4. Duration of response (DoR)

    Defined for all evaluable patients who have achieved an overall response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented.

    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 posted15 Feb 2017
  2. Study startJul 2017 (estimated)
  3. Primary completionJan 2021 (estimated)
  4. Study completionJul 2021 (estimated)

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
Model description
Open-label phase II study
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03054532
Sponsor's protocol ID
SDBCC-LYM-16-01
Status last verified
Feb 2017
First submitted
13 Feb 2017
Last updated
16 Feb 2017
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 Lenali in people with 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 20 inclusion and 11 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 16 Feb 2017. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Colin Phipps, MD (6562223322, colin.phipps.diong@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy as measured by overall response rate measured at the time of best response. (time frame: 2 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 NCT03054532.

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 16 Feb 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in