Follicular LymphomaPhase 2CUREMZL002NCT07585747
A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide
A Phase 2 study testing Orelabrutinib, Tafasitamab and Lenalidomide in people with Follicular Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 5 sites in China.
Trial summary
Evaluate the efficacy and safety of orelabrutinib, tafasitamab, and lenalidomide in the first-line treatment of patients with follicular lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Orelabrutinib, Tafasitamab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 5 sitesChina
- Study dates
- 15 Apr 2026to 31 Dec 2030
- 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, regardless of gender;
- Newly diagnosed patients with follicular lymphoma (Grade 1, 2, or 3a) confirmed histologicallyaccording to the World Health Organization (WHO) classification of diseases;
- Deemed by the investigator to have an indication for treatment and require therapy;
- ECOG performance status score of 0-2;
- Laboratory tests meeting the following criteria:
- Bone marrow hematopoietic function is essentially normal: WBC 3.5x10^9/L, ANC > 1.0x10^9/L, PLT > 75x10^9/L, Hb > 80 g/L;
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- Liver function: AST/ALT s 2xULN, TBILI s 2xULN;
- Renal function: Creatinine clearance rate > 50 ml/min;6. Presence of at least one measurable lesion: Lymph node lesion with a long diameter > 1.5 cm orextranodal lesion with a long diameter > 1.0 cm as shown by PET/CT, CT, or MRl, or a lesion > 2cm assessed by clinical examination;
- 7. Ability to provide written informed consent.
Who cannot join
- Women with a positive serum pregnancy test or who are breastfeeding;
- Patients with lymphoma involving the central nervous system (CNS);
- Clinically significant heart disease, including unstable angina, acute myocardial infarction within6 months prior to randomization, congestive heart failure with New York Heart Association(NYHA) functional class IIl or IV, or left ventricular ejection fraction <50%;
- Patients with grade >2 neuropathy;
- Patients with active hepatitis B (HBV, hepatitis C (HCV, or other acquired/congenitalimmunodeficiency diseases;
- Patients with severe active infections requiring systemic antibiotic treatment;
- Patients with a history of severe neurological or psychiatric disorders that impair trialparticipation, including dementia, epilepsy, severe depression, and mania;8. Drug abuse, or medical, psychological, or social conditions that may interfere with studyparticipation or result evaluation;
- 9. Patients deemed ineligible by the investigator.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Qilu Hospital of Shandong Province
Jinan, Shandong
jingjing Ye, 18560086995
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
Shenzhen Second People's Hospital
Shenzhen, Guangdong
xiaoqing Li, 18620385718
Institute of Hematology & Blood Diseases Hospital, China
Tianjin, Tianjin Municipality, 300020
Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official title: A Multicenter Exploratory Clinical Study on the Treatment of Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide
Evaluate the efficacy and safety of orelabrutinib, tafasitamab, and lenalidomide in the first-line treatment of patients with follicular lymphoma.
Read the detailed description
Follicular lymphoma (FL) is the most common indolent non-Hodgkin's lymphoma (NHL), accounting for 35% of NHL cases . The median age at diagnosis is 65 years , and most patients are diagnosed at an advanced stage. Although FL is still considered incurable, the clinical prognosis for most patients remains favorable.Currently, there is some data available for BTKi and tafasitamab in relapsed/refractory follicular lymphoma, and further exploration of relevant data in the first-line setting is needed. This combination therapy may provide new options for patients with follicular lymphoma.
- Conditions
- Follicular Lymphoma
- Being tested
- Orelabrutinib, Tafasitamab, Lenalidomide
- Keywords
- lenalidomide, tafasitamab, orelabrutinib
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrelabrutinibDrug
Orelabrutinib 150 mg orally once daily on Days 1-28 of each 28-day cycle during induction therapy and maintenance therapy.
TafasitamabDrug
Tafasitamab 12 mg/kg administered by intravenous infusion on Days 1, 4, 8, 15, and 22 in Cycle 1; on Days 1, 8, 15, and 22 in Cycles 2-3; and on Days 1 and 15 from Cycle 4 onward during induction therapy.
LenalidomideDrug
Lenalidomide 20 mg orally once daily on Days 1-21 of each 28-day cycle during induction therapy and 10 mg orally once daily on Days 1-21 of each 28-day cycle during maintenance therapy.
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib Tafasitamab Lenalidomide | Experimental | Orelabrutinib tafasitamab Lenalidomide Receives: Drug: Orelabrutinib; Drug: Tafasitamab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Percentage of participants achieving a Complete Response (CR) or Partial Response (PR) at the end of cycle 12, assessed according to the Lugano 2014 classification
Measured: At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)
Secondary outcomes (5)
Complete Response (CR) Rate
The complete response (CR) rate is defined as the percentage of participants who achieve a complete response at the end of cycle 12 , as assessed by the investigator according to the Lugano 2014 classification criteria
Measured: At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)
Progression-Free Survival (PFS)
The time from the start of treatment to disease progression or death from any cause.
Measured: Up to approximately 3 years
Rate of Progression of Disease within 24 Months (POD24)
Percentage of participants experiencing disease progression within 24 months from the initiation of treatment
Measured: 24 months
Incidence and Severity of Adverse Events (AEs)
Safety evaluated by monitoring the incidence and severity of AEs, graded according to the NCI CTCAE v5.0.
Measured: Up to approximately 3 years
Overall Survival (OS)
The time from the start of treatment to death from any cause.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start15 Apr 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 27 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585747
- Sponsor's protocol ID
- IIT2026026
- Acronym
- CUREMZL002
- Status last verified
- May 2026
- First submitted
- 13 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Exploratory Clinical Study on the Treatment of Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide
- ClinicalTrials.gov ID
- NCT07585747
- Acronym / sponsor ID
- CUREMZL002 / IIT2026026
- Conditions
- Follicular Lymphoma
- Keywords
- lenalidomide, tafasitamab, orelabrutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy and safety of orelabrutinib, tafasitamab, and lenalidomide in the first-line treatment of patients with follicular lymphoma.
Detailed description
Follicular lymphoma (FL) is the most common indolent non-Hodgkin's lymphoma (NHL), accounting for 35% of NHL cases . The median age at diagnosis is 65 years , and most patients are diagnosed at an advanced stage. Although FL is still considered incurable, the clinical prognosis for most patients remains favorable.Currently, there is some data available for BTKi and tafasitamab in relapsed/refractory follicular lymphoma, and further exploration of relevant data in the first-line setting is needed. This combination therapy may provide new options for patients with follicular lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib Tafasitamab Lenalidomide | Experimental | Drug: Orelabrutinib, Drug: Tafasitamab, Drug: LenalidomideOrelabrutinib tafasitamab Lenalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years, regardless of gender;
- Newly diagnosed patients with follicular lymphoma (Grade 1, 2, or 3a) confirmed histologicallyaccording to the World Health Organization (WHO) classification of diseases;
- Deemed by the investigator to have an indication for treatment and require therapy;
- ECOG performance status score of 0-2;
- Laboratory tests meeting the following criteria:
Key exclusion criteria (8 listed)
- Women with a positive serum pregnancy test or who are breastfeeding;
- Patients with lymphoma involving the central nervous system (CNS);
- Clinically significant heart disease, including unstable angina, acute myocardial infarction within6 months prior to randomization, congestive heart failure with New York Heart Association(NYHA) functional class IIl or IV, or left ventricular ejection fraction <50%;
- Patients with grade >2 neuropathy;
- Patients with active hepatitis B (HBV, hepatitis C (HCV, or other acquired/congenitalimmunodeficiency diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrelabrutinibOrelabrutinib 150 mg orally once daily on Days 1-28 of each 28-day cycle during induction therapy and maintenance therapy. | Drug | Orelabrutinib Tafasitamab Lenalidomide |
| TafasitamabTafasitamab 12 mg/kg administered by intravenous infusion on Days 1, 4, 8, 15, and 22 in Cycle 1; on Days 1, 8, 15, and 22 in Cycles 2-3; and on Days 1 and 15 from Cycle 4 onward during induction therapy. | Drug | Orelabrutinib Tafasitamab Lenalidomide |
| LenalidomideLenalidomide 20 mg orally once daily on Days 1-21 of each 28-day cycle during induction therapy and 10 mg orally once daily on Days 1-21 of each 28-day cycle during maintenance therapy. | Drug | Orelabrutinib Tafasitamab Lenalidomide |
Primary outcome
Objective Response Rate (ORR)
Time frame: At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)
Percentage of participants achieving a Complete Response (CR) or Partial Response (PR) at the end of cycle 12, assessed according to the Lugano 2014 classification
5 secondary outcomes
Complete Response (CR) Rate
Time frame: At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)
Progression-Free Survival (PFS)
Time frame: Up to approximately 3 years
Rate of Progression of Disease within 24 Months (POD24)
Time frame: 24 months
Incidence and Severity of Adverse Events (AEs)
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orelabrutinib, Tafasitamab and Lenalidomide in people with Follicular Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 5 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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 Shuhua Yi, Dr (+86-022-23909106, yishuhua@ihcams.ac.cn), 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: At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2026.