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DLBCLPhase 2NCT05552937

Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory DLBCL

A Phase 2 study testing Tafasitamab and Lenalidomide in people with DLBCL, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
DLBCL
What is being tested?
Tafasitamab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
6 Sep 2021to Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >18 years.
  • Histologically confirmed diagnosis of DLBCL not otherwise specified (NOS); T cell/histiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma, Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukaemia) into DLBCL with a subsequent DLBCL relapse are also eligible.
  • Patients received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy.
  • Patients must meet the following laboratory criteria at screening.
  • Patients must use an effective barrier method of contraception.
  • In the opinion of the investigator the patients must be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events; be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.

Who cannot join

  • Patients who have other histological type of lymphoma，primary refractory DLBCL，a history of "double/triple hit" genetics.
  • Patients who have, within 14 days prior to Day 1 dosing:
  • not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy.
  • undergone major surgery or suffered from significant traumatic injury.
  • received live vaccines.
  • required parenteral antimicrobial therapy for active, intercurrent infections.
Show all 19Show fewer
  • Patients who:
  • were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN).
  • have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.
  • have undergone previous allogenic stem cell transplantation.
  • have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period.
  • concurrently use other anticancer or experimental treatments.
  • Prior history of malignancies other than DLBCL.
  • Patients with:
  • positive hepatitis B and/or C serology.
  • known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).
  • CNS lymphoma involvement.
  • history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent.
  • history or evidence of severe hepatic impairment (total serum bilirubin > 3 mg/dL).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huili Zhou contact

86 571-87236685

Yixuelunli123@163.com

China1 site, 1 recruiting

  • The First Afflicated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310000

    Jie Jin, 0571-87236114, jiej0503@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This is a A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Conditions
DLBCL
Being tested
Tafasitamab and Lenalidomide

What participants receive

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

  • Tafasitamab and LenalidomideDrug

    Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle.

    Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.

Study groups in NCT05552937
Study groupRoleWhat they receive
Tafasitamab and LenalidomideExperimentalTafasitamab and lenalidomide will be coadministered for up to 12 cycles (28 days per cycle).followed by tafasitamab monotherapy (in participants with stable disease or better) until treatment withdrawal criteria are met.
Receives: Drug: Tafasitamab and Lenalidomide

What is being measured

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

  1. Objective response rate (ORR)

    Evaluation by the Independent Review Committee (IRC).

    Measured: 1-3 years approximately

Secondary outcomes (13)

  1. Objective Response Rate (ORR)

    Evaluated by the IRC according to cheson 2007 and cheson 2014.

    Measured: 1-3 years approximately

  2. Disease Control Rate (DCR)

    Measured: 1-3 years approximately

  3. Duration of Response (DOR)

    Measured: 1-3 years approximately

  4. Progression Free Survial (PFS)

    Measured: 1-3 years approximately

  5. Time to progression (TTP)

    Measured: 1-3 years approximately

  6. Time to response (TTR)

    Measured: 1-3 years approximately

  7. Overall Survival (OS)

    Measured: 1-3 years approximately

  8. Safety of Lenalidomide combined with Tafasitamab according to the frequency and severity of adverse events (AEs).

    Measured: 2 years

  9. Potential immunogenicity of Tafasitamab.

    Measured: 2 years

  10. Maximum serum concentration (Cmax)

    Measured: 2 years

  11. Time to maximum serum concentration (tmax)

    Measured: 2 years

  12. Apparent trough serum concentration before dosing (Cpd)

    Measured: 2 years

  13. Area under the serum concentration versus time curve from time 0 to the time t of the last quantifiable concentration (AUC0-t)

    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 posted23 Sep 2022
  2. Study start6 Sep 2021
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2027 (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
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05552937
Sponsor's protocol ID
ICP-CL-00901
Status last verified
Sep 2022
First submitted
21 Sep 2022
Last updated
23 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • You J, Chen W, Yan Z, Tian D, Yi H, Feng Y, Zhang M, Xing T, Wang Z, Zhao W, Xu P. Anti-CD19 antibody tafasitamab therapy for relapsed or refractory diffuse large B-cell lymphoma: a case series. Anticancer Drugs. 2026 Feb 1;37(2):123-127. doi: 10.1097/CAD.0000000000001774. Epub 2025 Oct 30.

    PubMed 41176775

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tafasitamab and Lenalidomide in people with DLBCL, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.

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 6 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Huili Zhou (86 571-87236685, Yixuelunli123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 1-3 years approximately). 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 NCT05552937, which also lists 1 linked publication.

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 23 Sep 2022.

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