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Status unknownNCT04231370Updated May 7, 2020

Lenalidomide and Sintilimab for Relapsed/Refractory NK/T-cell Lymphoma

A Phase 2 interventional study of Sintilimab and Lenalidomide in NK/T Cell Lymphoma Nos, sponsored by Beijing Tongren Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-07.

Sponsored by Beijing Tongren Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with lenalidomide in the treatment of Relapsed/Refractory NK/T-cell lymphoma patients who failed pegaspargase-based regimens.

Read the detailed description

Pegaspargase is the backbone of treatment for NK/T-cell lymphoma (ENKTCL), and patients with ENKTCL who failed pegaspargase-based regimens have extremely poor survival outcomes. Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). Constitutive activation of NF-kB pathway has been demonstrated to be involved in the development of ENKTCL and plays critical role in therapy resistance. Lenalidomide, an immuno-modulatory drug, has been found to inhibit NF-kB pathway, and synergize with anti-PD-1 antibody in the treatment of multiple myeloma. Thus, we hypothesize that the combination of lenalidomide and sintilimab will further deepen the remission status and benefit patients who failed pegaspargase-based regimens.

02

Conditions studied

  • NK/T Cell Lymphoma Nos

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Keywords

  • pegaspargase
  • sintilimab
  • PD-1
  • lenalidomide
  • relapsed/refractory
03

In context

Recurrence

4,347 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 3,429 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Beijing Tongren Hospital is the lead sponsor of 163 studies on the registry; 53 are open to participants now.

Browse Beijing Tongren Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria.
  • Previously treated with pegaspargase-based regimens (refractory or relapsed after initial remission).
  • PET/CT or CT/MRI with at least one objectively evaluable lesion.
  • General status ECOG score 0-3 points.
  • The laboratory test within 1 week before enrollment meets the following conditions:

Blood routine: Hb>80g/L, PLT>50×10（9）/L. Liver function: ALT, AST, TBIL ≤ 2 times the upper limit of normal. Renal function: Cr is normal. Coagulation : plasma fibrinogen ≥ 1.0g / L. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.

  • Sign the informed consent form.
  • Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations.

Exclusion criteria

Exclusion Criteria:

  • Patients with a history of pancreatitis.
  • Active infection requires ICU treatment.
  • Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are not excluded.
  • Serious complications such as fulminant DIC.
  • Significant organ dysfunction: such as respiratory failure, NYHA classification ≥ 2 chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure and diabetes that cannot be controlled despite active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past 6 months.
  • Pregnant and lactating women.
  • Had a history of autoimmune diseases, and disease was active in the last 6 months, and was still taking oral immunosuppression in the past three months.
  • Those who were known to be allergic to drugs in the study regimen.
  • Patients with other tumors who require surgery or chemotherapy within 6 months.
  • Other experimental drugs are being used.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    treatment arm

    Sintilimab, 200mg, iv day1 Lenalidomide, 25mg/d, oral, day 1-14 repeated every 3 weeks

    Drug: Sintilimab · Drug: Lenalidomide

Interventions

  • DrugSintilimab

    Sintilimab, 200mg, iv day1

    Also known as: anti-PD-1-antibody

  • DrugLenalidomide

    25mg/d oral d1-14

    Also known as: IMids

06

What researchers measure

Primary outcomes

  1. Rate of complete response

    evaluated by PET-CT and MRI, according to Lugano 2014 criteria

    Time frame: 24 weeks ±7 days

Secondary outcomes

  1. Rate of overall response

    evaluated by PET-CT and MRI, according to Lugano 2014 criteria

    Time frame: 24 weeks ±7 days

  2. 1-year progression free survival rate

    time from date of enrollment to date of disease progression, death of any reason, whichever comes first

    Time frame: up to 1year after enrollment

  3. 1-year overall survival rate

    time from date of enrollment to date of death of any reason

    Time frame: up to 1year after enrollment

  4. safety profiles

    according to CTCAE 4.0

    Time frame: up to 1year after enrollment

07

Study locations

1 of 1 sites recruiting
  • Beijing Tongren Hospital
    Beijing, 100730, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — All the data in the trial can be shared upon request to the PI.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2020 (actual). Primary completion is estimated for Feb 2022, 22 months after the start.

Of 409 non-industry phase 2 interventional studies under Recurrence, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 85. This study's planned 22 months is below that.

Counting every sponsor, half of 499 studies reached it within 49 months; a quarter within 31 and three quarters within 78.

Recurrence covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2020
First posted
Jan 18, 2020
StartActual
Apr 1, 2020
Primary completionEst.
Feb 28, 2022
CompletionEst.
Dec 31, 2022
Last update
May 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04231370
Lead sponsor
Beijing Tongren Hospital
Responsible party
JING-WEN WANG (Professor of Department of Hematology, Beijing Tongren Hospital) — Principal investigator
First posted
Jan 18, 2020
Start date
Apr 1, 2020
Primary completion
Feb 28, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
May 7, 2020

Study contacts

LIANG WANG, M.D.
Contact
wangliangtrhos@126.com
+8615013009093
Jing-wen Wang, M.D.
principal investigator · Beijing Tongren Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Sintilimab · Lenalidomide

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