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AzTrials

DLBCLPhase 3NCT06521255

Evaluate the Safety and Efficacy of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Phase 3 study testing Tafasitamab, Lenalidomide and Gemcitabine in people with DLBCL, run by Beijing InnoCare Pharma Tech Co., Ltd. at 20 sites 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
Search all trials

Trial summary

This is a Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination with Gemcitabine and Oxaliplatin versus Rituximab in Combination with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphom 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, Lenalidomide and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
20 sitesChina
Study dates
7 May 2024to Dec 2029
Phase
Phase 3
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

  • 18 Years and older.
  • One of the histologies of DLBCL confirmed by participated sites below with，not otherwise specified;T-cell/histiocyte-rich large B-cell lymphoma;Epstein-Barr virus (EBV) positive DLBCL (EBV-positive DLBCL); Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse; Disease transformed from an earlier diagnosis of low-grade lymphoma into DLBCL with DLBCL treatment failure.
  • Availability of tumor tissue biopsied post last line of therapy and prior to current study treatment for the patients enrolled in safety and tolerability stage.
  • Relapsed/refractory (R/R) DLBCL, at least one (≥1) but no more than three (≤3) line of prior systemic therapies.
  • Patients who have not received high dose therapy/stem cell transplantation (HDT/SCT) must be ineligible for HDT/SCT.
  • At least one measurable site of disease per CT or magnetic resonance imaging (the longest axis of the lymph node lesion is > 1.5 cm, and the longest diameter of the extra-nodal lesion is > 1.0 cm).
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  • ECOG PS score of 0 to 2.
  • Subject must have adequate organ functions, and the laboratory values comply with the protocol requirements.
  • Life expectancy of ≥ 3 months.
  • Informed consent before screening and can understand and comply with the requirements of the study.

Who cannot join

  • Existing or prior history of other malignant tumor within 3 years, except for those who have received curative treatment.
  • Current or history of central nervous system (CNS) lymphoma.
  • Known high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements.
  • Primary mediastinal B-cell lymphoma.
  • History of allogeneic stem-cell transplantation.
  • Prior exposure to anti-CD19 treatment, and (or) failed with gemcitabine plus platinum-based agent combination therapy.
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  • Current toxicity of ≥ Grade 2 from prior anti-cancer therapy (except for alopecia, neutrophil, hemoglobin and platelets).
  • Clinically significant cardiovascular disease or nervous system disease.
  • History of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period.
  • Uncontrolled systemic infection requiring parenteral intravenous anti-infective therapy.
  • Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B or C infection.

Trial locations and contacts

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

Weili Zhao contact

+86 021-64370045

zwl_trial@163.com

20 sites in 1 country

China20 sites, 20 recruiting

  • Beijing Hospital

    Beijing

    Hui Liu

    Not yet recruiting

  • The First Hospital Of Jilin University

    Changchun

    Ou Bai

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha

    Yajun Li

    Not yet recruiting

  • Chenzhou No.1 People's Hospital

    Chaozhou

    Xinquan Liang

    Not yet recruiting

  • Sichuan Province People's Hospital

    Chengdu

    Rong Xiao

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

    Hongbin Zhang

    Not yet recruiting

  • Guangdong General Hospital

    Guangzhou

    Wenyu Li

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou

    Qingqing Cai

    Recruiting

  • Hangzhou First People's Hospital

    Hangzhou

    Xiangmin Tong

    Not yet recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

    Wenjuan Yu

    Not yet recruiting

  • Shandong Cancer Hospital and Institute

    Jinan

    Zengjun Li

    Not yet recruiting

  • Jiangxi Cancer Hospital

    Nanchang

    Yan Huang

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanjing

    Fei Li

    Not yet recruiting

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai

    Weili Zhao

    Not yet recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou

    Bingzong Li

    Recruiting

  • Tianjin First Central Hospital

    Tianjin

    Qi Deng

    Not yet recruiting

  • Xinjiang Medical University Affiliated Cancer Hospital

    Ürümqi

    Shujuan Wen

    Not yet recruiting

  • The First Affiliated Hospital Wenzhou Medical University

    Wenzhou

    Songfu Jiang

    Not yet recruiting

  • Union Hospital Tongji Medical College

    Wuhan

    Liling Zhang

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Keshu Zhou

    Not yet recruiting

Other trials in China

About this study

Official title: A Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

This is a Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination with Gemcitabine and Oxaliplatin versus Rituximab in Combination with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphom

Conditions
DLBCL
Being tested
Tafasitamab, Lenalidomide, Gemcitabine, Oxaliplatin, Rituximab

What participants receive

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

  • TafasitamabDrug

    Tafasitmab was infused intravenously

  • LenalidomideDrug

    Lenalidomide orally

  • GemcitabineDrug

    Gemcitabine was infused intravenously

  • OxaliplatinDrug

    Oxaliplatin was infused intravenously

  • RituximabDrug

    Rituximab was infused intravenously.

Study groups in NCT06521255
Study groupRoleWhat they receive
Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatinExperimentalNot described
Receives: Drug: Tafasitamab; Drug: Lenalidomide; Drug: Gemcitabine; Drug: Oxaliplatin
Rituximab in combination with gemcitabine and oxaliplatinActive comparatorNot described
Receives: Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Rituximab

What is being measured

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

  1. Dose limiting toxicity（DLT）and other adverse events (AEs) of tafasitamab and lenalidomide in combination with GemOx (TL-GemOx) assessed using CTCAE v5.0

    Measured: within 28 days after therapy initiation

  2. PFS assessed by IRC according to Lugano 2014

    Measured: 1-3 years approximately

Secondary outcomes (10)

  1. Objective Response Rate (ORR) according to investigator.

    Measured: 1-3 years approximately

  2. Complete Response Rate (CRR) according to investigator.

    Measured: 1-3 years approximately

  3. Duration of Response (DOR) according to investigator.

    Measured: 1-3 years approximately

  4. Progression free survival (PFS) assessed by investigator according to the Lugano 2014

    Measured: 1-3 years approximately

  5. Time to response (TTR)

    Measured: 1-3 years approximately

  6. Overall Survival (OS)

    Measured: 1-3 years approximately

  7. Time to next treatment (TTNT)

    Measured: 1-3 years approximately

  8. Adverse events assessed by CTCAE version 5.0 criteria.

    Measured: 1-3 years approximately

  9. Quality of life assessment: Patient-reported outcomes (PROs) on happiness and general health status based on Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)

    Measured: 1-3 years approximately

  10. Quality of life assessment: Patient-reported outcomes (PROs) on happiness and general health status based on EuroQol five dimensions questionnaire (EQ-5D-5L)

    Measured: 1-3 years approximately

Timeline

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

  1. First posted25 Jul 2024
  2. Study start7 May 2024
  3. Primary completionSep 2028 (estimated)
  4. Study completionDec 2029 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
244 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06521255
Sponsor's protocol ID
ICP-CL-00903
Status last verified
Jun 2024
First submitted
15 Jul 2024
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tafasitamab, Lenalidomide and Gemcitabine in people with DLBCL, run by Beijing InnoCare Pharma Tech Co., Ltd. at 20 sites 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 10 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: looking for participants now, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Weili Zhao (+86 021-64370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity（DLT）and other adverse events (AEs) of tafasitamab and lenalidomide in combination with GemOx (TL-GemOx) assessed using CTCAE v5.0 (time frame: within 28 days after therapy initiation). The study lists 2 primary outcomes in all. 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 NCT06521255.

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 25 Jul 2024.

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