Rituximab, Lenalidomide, Zebutinib ，Mantle Cell LymphomaPhase 2NCT05992597
ZR2 Sequential Immunochemotherapy for Newly Treated MCL
A Phase 2 study testing ZR2 RDHAP in people with Rituximab, Lenalidomide, Zebutinib ，Mantle Cell Lymphoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Patients with newly diagnosed MCL were treated with ZR2 regimen for 3 cycles, followed by 3 cycles of immunochemotherapy, and zebrutinib maintenance therapy for 2 years after the end of induction therapy, in order to improve the remission rate and prognosis of patients with induction therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rituximab, Lenalidomide, Zebutinib ，Mantle Cell Lymphoma
- What is being tested?
- ZR2 RDHAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Dec 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participate in the clinical study voluntarily: fully understand and be informed of the study and sign the informed consent in person; Willing to follow and be able to complete all test procedures.
- 18~75 years old (inclusive), male and female.
- Histopathologically confirmed mantle cell lymphoma, including positive immunohistochemical CyclinD1 (CyclinD1 or CCND1) and/or chromosomal t (11; 14) (q13; Q32) ectopic.
- No prior anti-tumor therapy, such as chemotherapy, radiotherapy, immunotherapy or biotherapy (tumor vaccine, cytokine, or growth factor controlling cancer).
- there must be at least one evaluable or measurable lesion that meets Lugano2014 criteria (evaluable lesion: PET/CT examination showing increased uptake in lymph nodes or extratodal areas (higher than liver) and PET/CT and/or CT features consistent with lymphoma; Measurable lesions: nodular lesions >15mm in length or extragendal lesions >10mm in length with increased FDG uptake).
- Adequate organ and bone marrow function, no serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function and immune deficiency (no blood transfusion, granulocytic colony stimulating factor or other relevant medical support within 14 days prior to the use of the study drug) :
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- Blood routine: neutrophil absolute count (ANC) ≥1.5×109/L (1500/mm3), platelet ≥75×109/L, hemoglobin ≥100g/L (if bone marrow is involved, platelet ≥50×109/L, ANC ≥1.0×109/L, hemoglobin ≥80g/L).
- Liver function: serum bilirubin ≤2.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5 times the upper limit of normal value (AST is allowed if liver is involved, ALT≤5 times the upper limit of normal value).
- Renal function: creatinine clearance ≥60 mL/min (estimated according to the Cockcroft-Gault formula).
- Coagulation function: INR≤1.5 times the upper limit of normal value; PT and APTT≤1.5 times the upper limit of normal value.
- Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
- Male subjects used effective contraception from signing informed consent until 6 months after the last chemotherapy.
- Life expectancy > 3 months.
Who cannot join
- The diagnosis was leukemic mantle cell lymphoma.
- Central nervous system involvement secondary to lymphoma.
- history of other active malignant diseases within 2 years prior to study entry, but eligibility for inclusion :(1) adequately treated carcinoma in situ of the cervix; (2) local basal cell carcinoma or squamous cell carcinoma of skin; (3) Pre-existing malignant disease that is under control and has undergone local radical treatment (surgical or other forms).
- People with a known history of Human Immunodeficiency Virus (HIV) infection and/or acquired Immunodeficiency syndrome. Screening stage of hepatitis b surface antigen or hepatitis c virus antibody positive patients, must further by hepatitis b virus DNA (no more than 1000 iu/ml) and HCV RNA detection (shall not exceed the method detection limit), in the activity of the ruled out the need for treatment after hepatitis b or hepatitis c infection, before the experiment. Patients with hepatitis B virus carriers, stabilized hepatitis B after drug treatment and cured hepatitis C can be included.
- Major surgery was performed within 28 days prior to study initiation.
- Any active infections, including but not limited to bacterial, fungal or viral infections, that require systemic antiinfective therapy within 14 days prior to initiation of treatment.
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- combined with severe or uncontrolled disease, including but not limited to symptomatic of congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer or A history of severe hemorrhagic diseases, such as hemophilia a., hemophilia B, von willebrand disease or blood transfusion or other medical intervention history of spontaneous bleeding.
- History of stroke or intracranial hemorrhage within 6 months prior to first administration of the study drug.
- A history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months.
- Patients who must take antiplatelet drugs and anticoagulant drugs at the same time due to underlying diseases and have no alternative treatment plan.
- Continuous treatment with strong and moderate CYP3A inhibitors or CYP3A inducers is required. Patients were excluded if they had taken a CYP3A potent or moderate-acting inhibitor or inducer within 7 days prior to the first administration of the study drug (or had taken these drugs for less than 5 half-lives).
- Patients deemed unsuitable for the study by other investigators.
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
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Haiyan Yang, PhD, 0086-571-88122192, yanghy@zjcc.org.cn
Xi Chen, MD, 0086-571-88122192, zjuchenxi@126.com
About this study
Official title: Prospective, Single-arm, Single-center, Phase II Clinical Study of Rituximab, Lenalidomide, Zebutinib Combined Regimen Followed by Sequential Immunochemotherapy in the Treatment of Initially Treated Mantle Cell Lymphoma
Patients with newly diagnosed MCL were treated with ZR2 regimen for 3 cycles, followed by 3 cycles of immunochemotherapy, and zebrutinib maintenance therapy for 2 years after the end of induction therapy, in order to improve the remission rate and prognosis of patients with induction therapy.
Read the detailed description
This is a prospective, single-arm, multicenter, Phase II clinical study evaluating sequential immunochemotherapy followed by rituximab, lenalidomide, and zebutinib combined with or without autologous hematopoietic stem cell transplantation followed by zebutinib maintenance therapy for initial treatment of capsular cell lymphoma. There are three stages: screening, treatment and follow-up. The screening period was 28 days before the first administration. Treatment period: Enrolled subjects first received 3 cycles of rituximab, lenalidomide, zebutinib without chemotherapy (21 days for one cycle), followed by 3 cycles of RDHAP immunochemotherapy (21 days for one cycle); All patients were assessed with interim Positron Emission Tomography (iPET) after 3 cycles of rituximab, lenalidomide, and zebutinib without chemotherapy. All patients will continue to receive 3 cycles Of RDHAP, followed by Treatment End Of Positron Emission Tomography. For patients who have achieved complete metabolic response (CMR) or partial metabolic response (PMR), autologous hematopoietic stem cell transplantation (ASCT) can be performed as consolidation therapy after the researchers evaluate their physical status and their personal wishes. 3 months after ASCT, PET will be reviewed for efficacy evaluation after transplantation. Zebutinib maintenance therapy was started 2 months after transplantation for 2 years. For patients without ASCT, zebutinib maintenance therapy was started directly for 2 years. The follow-up period was entered after the end of maintenance therapy. Efficacy was evaluated using Lugano2014 criteria. Patients with disease progression during non-chemotherapy treatment were directly entered into RDHAP immunochemotherapy, and patients with disease progression during immunochemotherapy were directly removed from the group and entered second-line treatment. Objective effective rate, safety index and survival data of patients were observed during the experiment. Subjects will enter the follow-up period after the study treatment is discontinued or the treatment period has been completed.
- Being tested
- ZR2 RDHAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZR2 RDHAPDrug
ZR2:Rituximab 375mg/m2, D1, Lenalidomide 24mg qd D1-14, zebutinib 160mg bid RDHAP:Rituximab 375mg/m2 D0, dexamethasone 40mg D1-4, cytarabine 2g/m2 q12h D2, cisplatin 25mg/m2 D1-3.
| Study group | Role | What they receive |
|---|---|---|
| rituximab, lenalidomide, and zebutinib,RDHAP | Experimental | Not described Receives: Drug: ZR2 RDHAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
overall response rate
Measured: Time Frame: 21days after the end of treatment
Secondary outcomes (3)
PFS
Progression Free Survival
Measured: Time Frame: From date of first day of treatment until the date of first documented progression, assessed up to 24 months
OS
Overall Survival
Measured: Time Frame: From date of first day of treatment until the date of first documented date of death from any cause, assessed up to 24 months
AE and SAE
Adverse event and serious adverse event
Measured: Time Frame: From date of first day of treatment until 30 day after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Aug 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rituximab, Lenalidomide, Zebutinib ，Mantle Cell LymphomaStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang haiyan, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992597
- Sponsor's protocol ID
- ZR2 + RDHAP
- Status last verified
- Sep 2023
- First submitted
- 8 Aug 2023
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Single-center, Phase II Clinical Study of Rituximab, Lenalidomide, Zebutinib Combined Regimen Followed by Sequential Immunochemotherapy in the Treatment of Initially Treated Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05992597
- Acronym / sponsor ID
- ZR2 + RDHAP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 Aug 2023 (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.
Patients with newly diagnosed MCL were treated with ZR2 regimen for 3 cycles, followed by 3 cycles of immunochemotherapy, and zebrutinib maintenance therapy for 2 years after the end of induction therapy, in order to improve the remission rate and prognosis of patients with induction therapy.
Detailed description
This is a prospective, single-arm, multicenter, Phase II clinical study evaluating sequential immunochemotherapy followed by rituximab, lenalidomide, and zebutinib combined with or without autologous hematopoietic stem cell transplantation followed by zebutinib maintenance therapy for initial treatment of capsular cell lymphoma. There are three stages: screening, treatment and follow-up. The screening period was 28 days before the first administration. Treatment period: Enrolled subjects first received 3 cycles of rituximab, lenalidomide, zebutinib without chemotherapy (21 days for one cycle), followed by 3 cycles of RDHAP immunochemotherapy (21 days for one cycle); All patients were assessed with interim Positron Emission Tomography (iPET) after 3 cycles of rituximab, lenalidomide, and zebutinib without chemotherapy. All patients will continue to receive 3 cycles Of RDHAP, followed by Treatment End Of Positron Emission Tomography. For patients who have achieved complete metabolic response (CMR) or partial metabolic response (PMR), autologous hematopoietic stem cell transplantation (ASCT) can be performed as consolidation therapy after the researchers evaluate their physical status and their personal wishes. 3 months after ASCT, PET will be reviewed for efficacy evaluation after transplantation. Zebutinib maintenance therapy was started 2 months after transplantation for 2 years. For patients without ASCT, zebutinib maintenance therapy was started directly for 2 years. The follow-up period was entered after the end of maintenance therapy. Efficacy was evaluated using Lugano2014 criteria. Patients with disease progression during non-chemotherapy treatment were directly entered into RDHAP immunochemotherapy, and patients with disease progression during immunochemotherapy were directly removed from the group and entered second-line treatment. Objective effective rate, safety index and survival data of patients were observed during the experiment. Subjects will enter the follow-up period after the study treatment is discontinued or the treatment period has been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rituximab, lenalidomide, and zebutinib,RDHAP | Experimental | Drug: ZR2 RDHAP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participate in the clinical study voluntarily: fully understand and be informed of the study and sign the informed consent in person; Willing to follow and be able to complete all test procedures.
- 18~75 years old (inclusive), male and female.
- Histopathologically confirmed mantle cell lymphoma, including positive immunohistochemical CyclinD1 (CyclinD1 or CCND1) and/or chromosomal t (11; 14) (q13; Q32) ectopic.
- No prior anti-tumor therapy, such as chemotherapy, radiotherapy, immunotherapy or biotherapy (tumor vaccine, cytokine, or growth factor controlling cancer).
- there must be at least one evaluable or measurable lesion that meets Lugano2014 criteria (evaluable lesion: PET/CT examination showing increased uptake in lymph nodes or extratodal areas (higher than liver) and PET/CT and/or CT features consistent with lymphoma; Measurable lesions: nodular lesions >15mm in length or extragendal lesions >10mm in length with increased FDG uptake).
Key exclusion criteria (12 listed)
- The diagnosis was leukemic mantle cell lymphoma.
- Central nervous system involvement secondary to lymphoma.
- history of other active malignant diseases within 2 years prior to study entry, but eligibility for inclusion :(1) adequately treated carcinoma in situ of the cervix; (2) local basal cell carcinoma or squamous cell carcinoma of skin; (3) Pre-existing malignant disease that is under control and has undergone local radical treatment (surgical or other forms).
- People with a known history of Human Immunodeficiency Virus (HIV) infection and/or acquired Immunodeficiency syndrome. Screening stage of hepatitis b surface antigen or hepatitis c virus antibody positive patients, must further by hepatitis b virus DNA (no more than 1000 iu/ml) and HCV RNA detection (shall not exceed the method detection limit), in the activity of the ruled out the need for treatment after hepatitis b or hepatitis c infection, before the experiment. Patients with hepatitis B virus carriers, stabilized hepatitis B after drug treatment and cured hepatitis C can be included.
- Major surgery was performed within 28 days prior to study initiation.
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 |
|---|---|---|
| ZR2 RDHAPZR2:Rituximab 375mg/m2, D1, Lenalidomide 24mg qd D1-14, zebutinib 160mg bid RDHAP:Rituximab 375mg/m2 D0, dexamethasone 40mg D1-4, cytarabine 2g/m2 q12h D2, cisplatin 25mg/m2 D1-3. | Drug | rituximab, lenalidomide, and zebutinib,RDHAP |
Primary outcome
ORR
Time frame: Time Frame: 21days after the end of treatment
overall response rate
3 secondary outcomes
PFS
Time frame: Time Frame: From date of first day of treatment until the date of first documented progression, assessed up to 24 months
OS
Time frame: Time Frame: From date of first day of treatment until the date of first documented date of death from any cause, assessed up to 24 months
AE and SAE
Time frame: Time Frame: From date of first day of treatment until 30 day after last treatment
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 21 Sep 2023.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZR2 RDHAP in people with Rituximab, Lenalidomide, Zebutinib ，Mantle Cell Lymphoma, run by Zhejiang Cancer Hospital 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 13 inclusion and 12 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 21 Sep 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Time Frame: 21days after the end of treatment). 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 21 Sep 2023.