Double Expressor DLBCLPhase 2CR2NCT07884708
Chidamide, Lenalidomide, and Rituximab in Newly Diagnosed Elderly/unFit DE-DLBCL
A Phase 2 study testing Chidamide in combination with Lenalidomide and Rituximab (CR2) in people with Double Expressor DLBCL and ELDERLY PEOPLE, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Chidamide in combination with lenalidomide and rituximab (CR2) as induction therapy, followed by chidamide maintenance in responding patients with newly diagnosed elderly/unfit double-expressor DLBCL. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Double Expressor DLBCL, ELDERLY PEOPLE, Unfit, New-diagnosis DLBCL
- What is being tested?
- Chidamide in combination with Lenalidomide and Rituximab (CR2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2024to 11 Mar 2027
- Phase
- Phase 2
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed, previously untreated DLBCL;
- Age ≥70 years, or ≥60 years with comorbidities (including reduced left ventricular ejection fraction, history of myocardial infarction [>6 months prior to enrollment], exertional angina, arrhythmia [Grade ≤2], hypertension or diabetes requiring treatment), or ECOG PS ≥2 deemed ineligible for standard chemotherapy;
- At least one measurable lesion, defined as: Nodal lesion: Longest diameter >1.5 cm, or Extranodal lesion: Longest diameter >1.0 cm, with two perpendicular dimensions accurately measurable;
- ECOG PS ≤3;
- Estimated life expectancy ≥3 months
- MYC and BCL2 protein co-expression confirmed by immunohistochemistry (double-expressor lymphoma)
- Voluntary participation; full understanding of the study with signed informed consent; willingness and ability to comply with all study procedures
Who cannot join
- Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception;
- Recipients of organ transplantation;
- Uncontrolled coagulopathy or active bleeding;
- Uncontrolled cardiocerebrovascular diseases (including LVEF <50%), connective tissue diseases, or severe active infections;
- Major organ surgery within 6 weeks prior to screening;
- Laboratory abnormalities at screening (unless lymphoma-related): Neutrophils <1.5×10⁹/L; Platelets <80×10⁹/L (<50×10⁹/L if bone marrow involvement); Liver dysfunction: Total bilirubin >1.5×ULN, ALT/AST >2.5×ULN (or >5×ULN with liver involvement); Renal dysfunction: Serum creatinine >1.5×ULN;
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- HBV infection: HBsAg-positive patients: Eligible if HBV DNA <10³ IU/mL; HBsAg-negative but HBcAb-positive (regardless of HBsAb status): Eligible if HBV DNA <10³ IU/mL;
- HIV infection;
- Central nervous system lymphoma involvement;
- Concurrent antitumor therapy (for lymphoma or other malignancies);
- Substance abuse or chronic alcoholism affecting outcome evaluation;
- Psychiatric disorders or other conditions compromising protocol compliance;
- Concurrent use of strong/moderate CYP3A4 inhibitors/inducers: Excluded if taken within 7 days prior to treatment (or <5 half-lives);
- Inability to swallow capsules or significant gastrointestinal dysfunction (e.g., malabsorption, bariatric surgery, IBD, bowel obstruction);
- Other uncontrolled conditions deemed by investigators to: Jeopardize patient safety; Interfere with drug absorption/metabolism; Pose excessive risk to study outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
Lei Fan, Doctor, 86-13813976136, fanlei3014@126.com
Fan
About this study
Official title: Efficacy and Safety of Chidamide in Combination With Lenalidomide and Rituximab (CR2) in Newly Diagnosed Elderly/unFit Double-Expressor DLBCL: A Prospective, Single-Arm, Multicenter Clinical Study
To evaluate the efficacy and safety of Chidamide in combination with lenalidomide and rituximab (CR2) as induction therapy, followed by chidamide maintenance in responding patients with newly diagnosed elderly/unfit double-expressor DLBCL.
- Being tested
- Chidamide in combination with Lenalidomide and Rituximab (CR2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide in combination with Lenalidomide and Rituximab (CR2)Drug
The treatment consists of induction therapy followed by maintenance therapy.
Induction Therapy: Chidamide + Lenalidomide + Rituximab.
Maintenance Therapy: Patients with ≥PR after 8 cycles receive: Chidamide+ Lenalidomide for 1 year (unless disease progression or intolerable toxicity occurs, whichever comes first).
Investigators may adjust drug doses/schedules based on individual tolerance.
| Study group | Role | What they receive |
|---|---|---|
| newly diagnosed elderly/unfit DE-DLBCL patients | Experimental | newly diagnosed elderly/unfit (Patients aged ≥70 years, or aged ≥60 years with comorbidities, or those with ECOG PS ≥2 deemed ineligible for standard chemotherapy) Double-Expressor Diffuse Large B-Cell Lymphoma patients Receives: Drug: Chidamide in combination with Lenalidomide and Rituximab (CR2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of study drug to the first documented disease progression, relapse, or death from any cause, whichever occurs first
Measured: From date of first dose until date of progression, relapse, or death from any cause, assessed up to 3 years.
Secondary outcomes (3)
Objective Response Rate (ORR)
Objective response is defined as complete response (CR) or partial response (PR) assessed according to Lugano 2014 criteria
Measured: Assessed at baseline and up to 8 cycles of chemotherapy (each cycle is 28 days), up to approximately 24 weeks
Overall Survival (OS)
OS is defined as the time from the first dose of study drug to death from any cause
Measured: From date of first dose until date of death from any cause, assessed up to 3 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Descriptive statistics were used to summarize investigational drug exposure, including treatment duration, number of administrations, and dose levels. Adverse events were graded according to NCI CTCAE version 5.0. Safety will be assessed throughout the treatment and follow-up periods
Measured: From first dose of study drug through 30 days after the last dose, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start11 Mar 2024
- Primary completion11 Mar 2027 (estimated)
- Study completion11 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double Expressor DLBCLStudies of the same condition, open and under way.
- 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884708
- Sponsor's protocol ID
- 2024-SR-1006
- Acronym
- CR2
- Status last verified
- Oct 2026
- First submitted
- 23 Jun 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No