Peripheral T-Cell LymphomaPhase 2NCT04922567
Efficacy and Safety of Lenalidomide Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
A Phase 2 study testing Lenalidomide, Cyclophosphamide and Doxorubicin in people with Peripheral T-Cell Lymphoma and Lenalidomide, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to compare the efficacy and safety of lenalidomide plus CHOP (L-CHOP) versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral T-Cell Lymphoma, Lenalidomide, CHOP
- What is being tested?
- Lenalidomide, Cyclophosphamide and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 31 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
- Patients with histologically proven untreated peripheral T-cell lymphoma (include PTCL not otherwise specified, angioimmunoblastic T cell lymphoma, anaplastic large cell lymphoma, enteropathy-associated T cell lymphoma, Monomorphic epitheliotropic intestinal T-cell lymphoma, Nodal peripheral T-cell lymphoma with T-follicular helper phenotype and Follicular T-cell lymphoma).
- Males and females of 18 years of age to 80 years of age.
- Patients have not received anti-tumor therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Fit chemotherapy indications and basic requirements, including no obvious abnormal function of heart, liver, lung and kidney: creatine ≤2.0×ULN, total bilirubin ≤2.0mg/dl, transaminases≤3×ULN.
- Normal peripheral hemogram: absolute neutrophil count(ANC)≥1.5×10^9/L, hemoglobin(Hb)≥90g/L, platelet(PLT)≥100×10^12/L.
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- None of other serious disease conflict with the therapeutic regimen.
- None of other malignant tumor.
- Pregnancy test of women at reproductive age must be negative.
- Estimated survival time ≥ 3 months with good compliance.
- Voluntary participation, cooperate with the experimental observation, and sign a written informed consent.
Who cannot join
- Patients with the following PTCL subtypes are excluded; extranodal natural killer(NK)/T-cell lymphoma, T-prolymphocytic leukemia, T large granular lymphocytic leukemia, chronic lymphoproliferative disorder of NK cells, aggressive NK-cell leukemia, adult T-cell leukemia/ lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous T cell lymphoma, breast implant-associated anaplastic large-cell lymphoma.
- Transformed lymphoma.
- Patients with other malignancies in the past or now; or secondary lymphoma triggered by chemotherapy or radiotherapy of other malignancies.
- Already initiated lymphoma therapy (except for the prephase treatment specified for this study).
- Patients with primary central nervous system lymphoma or lymphoma involving central nervous system.
- Patients who have central nervous system or meninges involvements.
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- Candidate for hematopoietic stem cell transplantation.
- Known hypersensitivity to medications to be used.
- Hemogram abnormality: ANC<1.5×10^9/L; or hemoglobin<90 g/L; or PLT<100×10^9/L.
- Known hepatic and renal insufficiency (creatine>2.0×ULN, total bilirubin>2.0 mg/dl，transaminases>3.0×ULN).
- Patients with decompensated heart failure; or with dilated cardiomyopathy; or with coronary heart disease of non-corresponding ST-segment in ECG diagnosis; or with myocardial infarction within 6 months.
- Patients with serious uncontrolled acute infection need to be treated with antibody therapies, or antiviral therapies; or serious accompanying disorder or impaired organ function.
- Know HIV-positivity; or HbsAg positivity; or hepatitis C virus-Ab positivity.
- Pregnancy or lactation period.
- Patients who participated in other clinical trials within 3 months.
- The researchers considered that patients should not be in this trial.
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
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Wenbing Qian, M.D.,PhD., +8613605801032, qianwb@zju.edu.cn
About this study
Official title: Multi-center Randomized Study to Compare Efficacy and Safety of Lenalidomide Plus CHOP (L-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
This study aims to compare the efficacy and safety of lenalidomide plus CHOP (L-CHOP) versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL)
Read the detailed description
This is a randomized, multi-center, open-label study to compare efficacy and safety of L-CHOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles or Lenalidomide plus CHOP (L-CHOP) administered in 3 week cycles for 6 cycles. In the L-CHOP arm, Lenalidomide will be administered at a dose of 25mg po on day 1-10 every 3 weeks. This study is divided into three phases: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary with drawl. Adverse event of every treatment cycle will be recorded. Therapy efficacy will be evaluated after finishing 3 cycles and finishing 6 cycles therapy. Patients will be followed until disease progression, died or 3 years from the last patient randomized.
- Conditions
- Peripheral T-Cell Lymphoma, Lenalidomide, CHOP
- Being tested
- Lenalidomide, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
25mg po on day 1-10
CyclophosphamideDrug
750mg/m² iv on day1
DoxorubicinDrug
50mg/m² iv on day 1
VincristineDrug
1.4mg/m² iv on day 1
PrednisoneDrug
100mg po on day1-5
| Study group | Role | What they receive |
|---|---|---|
| lenalidomide + CHOP regimen | Experimental | Not described Receives: Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone |
| CHOP regimen | Active comparator | Not described Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response rate
complete response (CR) and partial response (PR) rates, using the standard response criteria( 2014 Lugano criteria)
Measured: At the end of Cycle 6 (each cycle is 21 days)
Secondary outcomes (3)
Progression Free Survival
from date of inclusion to date of progression, relapse, or death from any cause
Measured: 3 years
Overall Survival
From the date of inclusion to date of death, irrespective of cause
Measured: 3 years
Adverse Events
Any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 289 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Xinqiao Hospital of Chongqing, Union hospital of Fujian Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Southern Medical University, China, Shandong Provincial Hospital, Huashan Hospital, First Hospital of China Medical University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Henan Provincial People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, Changhai Hospital, The Affiliated Hospital of Xuzhou Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, RenJi Hospital, Zhongda Hospital, The First Affiliated Hospital of Anhui Medical University, Hunan Cancer Hospital, First Affiliated Hospital of Harbin Medical University, Xiangya Hospital of Central South University, The First Affiliated Hospital of Dalian Medical University, Jilin Provincial Tumor Hospital, Shanxi Province Cancer Hospital, Zhongshan Hospital Xiamen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922567
- Sponsor's protocol ID
- IR2020002513
- Status last verified
- Oct 2022
- First submitted
- 5 Jun 2021
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Randomized Study to Compare Efficacy and Safety of Lenalidomide Plus CHOP (L-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04922567
- Acronym / sponsor ID
- IR2020002513
- Conditions
- Peripheral T-Cell Lymphoma, Lenalidomide, CHOP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 289 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Xinqiao Hospital of Chongqing, Union hospital of Fujian Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Southern Medical University, China, Shandong Provincial Hospital, Huashan Hospital, First Hospital of China Medical University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Henan Provincial People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, Changhai Hospital, The Affiliated Hospital of Xuzhou Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, RenJi Hospital, Zhongda Hospital, The First Affiliated Hospital of Anhui Medical University, Hunan Cancer Hospital, First Affiliated Hospital of Harbin Medical University, Xiangya Hospital of Central South University, The First Affiliated Hospital of Dalian Medical University, Jilin Provincial Tumor Hospital, Shanxi Province Cancer Hospital, Zhongshan Hospital Xiamen University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jun 2021 (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.
This study aims to compare the efficacy and safety of lenalidomide plus CHOP (L-CHOP) versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL)
Detailed description
This is a randomized, multi-center, open-label study to compare efficacy and safety of L-CHOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles or Lenalidomide plus CHOP (L-CHOP) administered in 3 week cycles for 6 cycles. In the L-CHOP arm, Lenalidomide will be administered at a dose of 25mg po on day 1-10 every 3 weeks. This study is divided into three phases: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary with drawl. Adverse event of every treatment cycle will be recorded. Therapy efficacy will be evaluated after finishing 3 cycles and finishing 6 cycles therapy. Patients will be followed until disease progression, died or 3 years from the last patient randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lenalidomide + CHOP regimen | Experimental | Drug: Lenalidomide, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone |
| CHOP regimen | Active comparator | Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histologically proven untreated peripheral T-cell lymphoma (include PTCL not otherwise specified, angioimmunoblastic T cell lymphoma, anaplastic large cell lymphoma, enteropathy-associated T cell lymphoma, Monomorphic epitheliotropic intestinal T-cell lymphoma, Nodal peripheral T-cell lymphoma with T-follicular helper phenotype and Follicular T-cell lymphoma).
- Males and females of 18 years of age to 80 years of age.
- Patients have not received anti-tumor therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Fit chemotherapy indications and basic requirements, including no obvious abnormal function of heart, liver, lung and kidney: creatine ≤2.0×ULN, total bilirubin ≤2.0mg/dl, transaminases≤3×ULN.
Key exclusion criteria (16 listed)
- Patients with the following PTCL subtypes are excluded; extranodal natural killer(NK)/T-cell lymphoma, T-prolymphocytic leukemia, T large granular lymphocytic leukemia, chronic lymphoproliferative disorder of NK cells, aggressive NK-cell leukemia, adult T-cell leukemia/ lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous T cell lymphoma, breast implant-associated anaplastic large-cell lymphoma.
- Transformed lymphoma.
- Patients with other malignancies in the past or now; or secondary lymphoma triggered by chemotherapy or radiotherapy of other malignancies.
- Already initiated lymphoma therapy (except for the prephase treatment specified for this study).
- Patients with primary central nervous system lymphoma or lymphoma involving central nervous system.
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 |
|---|---|---|
| Lenalidomide25mg po on day 1-10 | Drug | lenalidomide + CHOP regimen |
| Cyclophosphamide750mg/m² iv on day1 | Drug | CHOP regimen, lenalidomide + CHOP regimen |
| Doxorubicin50mg/m² iv on day 1 | Drug | CHOP regimen, lenalidomide + CHOP regimen |
| Vincristine1.4mg/m² iv on day 1 | Drug | CHOP regimen, lenalidomide + CHOP regimen |
| Prednisone100mg po on day1-5 | Drug | CHOP regimen, lenalidomide + CHOP regimen |
Primary outcome
Objective Response rate
Time frame: At the end of Cycle 6 (each cycle is 21 days)
complete response (CR) and partial response (PR) rates, using the standard response criteria( 2014 Lugano criteria)
3 secondary outcomes
Progression Free Survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
Adverse Events
Time frame: 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 7 Nov 2022.
- 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.
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 Lenalidomide, Cyclophosphamide and Doxorubicin in people with Peripheral T-Cell Lymphoma and Lenalidomide, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 11 inclusion and 16 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 7 Nov 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 Wenbin Qian, Prof. (+86-13605801032, qianwb@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response rate (time frame: At the end of Cycle 6 (each cycle is 21 days)). 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 7 Nov 2022.