Angioimmunoblastic T-cell LymphomaAITLNCT04319601
Rituximab Combined With Chidamide and Lenalidomide for r/r AITL
A study testing Rituximab in people with Angioimmunoblastic T-cell Lymphoma and Chemotherapy Effect, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This study is designed to explore the effeicency and toxicities of rituximab combined with chidamide and lenalidomide in patients with relapsed or refractory AITL. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Angioimmunoblastic T-cell Lymphoma, Chemotherapy Effect, Chemotherapeutic Toxicity
- What is being tested?
- Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must voluntarily participate in this study and sign an informed consent.
- 18-70 years old.
- ECOG 0-2.
- Life expectancy ≥12 weeks.
- Histopathology diagnosis of AITL.
- A measurable lesion (lymphoma nodule, lymph node mass or other lymphoma lesions as defined in lugano 2014) that can be measured in both diameters on the CT scan, including the longest diameter and the shortest diameter perpendicular to the longest diameter.In addition, the longest diameter of lymph nodes should be greater than 1.5cm, and the longest diameter of external lymph node lesions should be greater than 1.0cm.
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- The patient has received at least one line of systemic chemotherapy and currently has disease progression or treatment failure, or the patient refuses or cannot tolerate intravenous chemotherapy.
- Adequate bone marrow hematopoietic function reserve and viscera function, as follows:
- Liver function: ALT, AST≤2.5 times the normal upper limit, if there is liver metastasis, ≤5 times the normal upper limit;Total bilirubin, direct bilirubin ≤1.5 times the normal upper limit.
- Bone marrow function (growth factor should not be used within 7 days before the first medication) : WBC ≥2.0109/l;The ANC acuity 1.0 109 / l;PLT 50 109 / l or higher;Hb 8 g/dl or higher.
- Renal function: creatinine ≤1.5 times the normal upper limit or creatinine clearance ≥30ml/min.
- Cardiac function: LVEF≥50%. Lung function: resting and oxygen saturation ≥95% without oxygen inhalation. Coagulation function: international standardized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (aPTT) ≤1.5×ULN, unless the patient is receiving anticoagulation therapy and the coagulation parameters (prothrombin time [PT/INR] and aPTT) at the time of screening are within the expected range of anticoagulant treatment.Patients whose prolongation of PT or elevation of INR resulted from the use of clotting factor inhibitors were eligible for inclusion by the investigator.
Who cannot join
- Prior to the first use of the drug in this study, there was an unrelieved drug toxicity greater than CTCAE1 (except for the adverse reactions, such as hair loss, that the investigator assessed did not affect the use of the drug in this study).
- Presence of active infection, including but not limited to: known active/latent tuberculosis, herpes zoster, pneumonia.
- 3, Known human immunodeficiency virus (HIV) infection, or reflect the activity of hepatitis b virus (HBV) or hepatitis c virus (HCV) infection of serological status: a. the hepatitis b surface antigen (HBsAg) positive, HBcAb positive, HBsAg positive patients should be detected HBV - DNA, if not more than 1000 iu/ml and agreed to accept patients treated against HBV virus can enter the group.B. patients with positive HCV antibody are admitted if HCV RNA (<15 IU/mL) is not detected.
- 4. Patients with heart failure of grade 3 or 4 according to the New York society of cardiology (NYHA) functional classification, unstable angina, severe poorly controlled ventricular arrhythmia, electrocardiogram showing acute ischemia or myocardial infarction 6 months prior to screening.Or other cardiac dysfunction assessed by the investigator as not resistant to chemotherapy.
- 5. Support the treatment of refractory nausea, vomiting, chronic gastrointestinal diseases, capsule dysphagia, or previous surgical resection of the intestinal segment may affect the full absorption of drugs.
- 6. The investigator's judgment or other evidence indicates that the patient has serious or poorly controlled systemic diseases, including poorly controlled hypertension and an active bleeding constitution.At present, patients with thrombotic diseases such as pulmonary embolism and deep vein thrombosis are also not suitable to participate in this study.
- 7. Nursing or pregnant women. 8. The researcher judged that the patient had other factors that might affect the compliance of the plan.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Haiyan Yang, PhD, 0086-571-88122192, yanghy@zjcc.org.cn
Cong Li, MD, 0086-571-88122192, licong@zjcc.org.cn
About this study
Official title: A Single-arm, Multiple Centers, Phase II Study Evaluating Rituximab in Combination With Chidamide and Lenalidomide for Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma (AITL)
This study is designed to explore the effeicency and toxicities of rituximab combined with chidamide and lenalidomide in patients with relapsed or refractory AITL.
Read the detailed description
This study is designed to explore the effeicency and toxicities of rituximab combined with chidamide and lenalidomide in patients with relapsed or refractory AITL. The primary end point is PFS, and second end point is OS, ORR and toxicities according to CTCAE 5.0.
- Being tested
- Rituximab
- Medical subject headings
- Immunoblastic Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called chidamide, lenalidomde
a new chemotherapy regimen
| Study group | Role | What they receive |
|---|---|---|
| rituximab combined with chidamde and lenalidomide | Experimental | rituximab and chidamide, lenalidomide Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression free survival
Measured: From enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months
Secondary outcomes (2)
ORR
overall response rate
Measured: From enrollment until date of completion of chemotherapy, assessed up to 9 months
toxicities
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: from enrollment to 30 days after completion of chemotherapy, assessed up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start13 Mar 2020
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angioimmunoblastic T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 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
- Investigators
- Ming Chen, PhD, Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319601
- Sponsor's protocol ID
- RLC
- Acronym
- AITL
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li C, Lei T, Xu X, Lu J, Zhu X, Chen Z, Weng X, Yu H, Chen X, Peng S, Han S, Yang H. RCLARITY: A Prospective Phase II Study of Rituximab Combined With Lenalidomide and Chidamide (RLC) for the Treatment of Relapsed/Refractory Angioimmunoblastic T-Cell Lymphoma. Am J Hematol. 2026 May 12. doi: 10.1002/ajh.70366. Online ahead of print.
PubMed 42124356
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multiple Centers, Phase II Study Evaluating Rituximab in Combination With Chidamide and Lenalidomide for Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma (AITL)
- ClinicalTrials.gov ID
- NCT04319601
- Acronym / sponsor ID
- AITL / RLC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Mar 2020 (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 is designed to explore the effeicency and toxicities of rituximab combined with chidamide and lenalidomide in patients with relapsed or refractory AITL.
Detailed description
This study is designed to explore the effeicency and toxicities of rituximab combined with chidamide and lenalidomide in patients with relapsed or refractory AITL. The primary end point is PFS, and second end point is OS, ORR and toxicities according to CTCAE 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rituximab combined with chidamde and lenalidomide | Experimental | Drug: Rituximabrituximab and chidamide, lenalidomide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must voluntarily participate in this study and sign an informed consent.
- 18-70 years old.
- ECOG 0-2.
- Life expectancy ≥12 weeks.
- Histopathology diagnosis of AITL.
Key exclusion criteria (7 listed)
- Prior to the first use of the drug in this study, there was an unrelieved drug toxicity greater than CTCAE1 (except for the adverse reactions, such as hair loss, that the investigator assessed did not affect the use of the drug in this study).
- Presence of active infection, including but not limited to: known active/latent tuberculosis, herpes zoster, pneumonia.
- 3, Known human immunodeficiency virus (HIV) infection, or reflect the activity of hepatitis b virus (HBV) or hepatitis c virus (HCV) infection of serological status: a. the hepatitis b surface antigen (HBsAg) positive, HBcAb positive, HBsAg positive patients should be detected HBV - DNA, if not more than 1000 iu/ml and agreed to accept patients treated against HBV virus can enter the group.B. patients with positive HCV antibody are admitted if HCV RNA (<15 IU/mL) is not detected.
- 4. Patients with heart failure of grade 3 or 4 according to the New York society of cardiology (NYHA) functional classification, unstable angina, severe poorly controlled ventricular arrhythmia, electrocardiogram showing acute ischemia or myocardial infarction 6 months prior to screening.Or other cardiac dysfunction assessed by the investigator as not resistant to chemotherapy.
- 5. Support the treatment of refractory nausea, vomiting, chronic gastrointestinal diseases, capsule dysphagia, or previous surgical resection of the intestinal segment may affect the full absorption of drugs.
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 |
|---|---|---|
| RituximabAlso: chidamide, lenalidomdea new chemotherapy regimen | Drug | rituximab combined with chidamde and lenalidomide |
Primary outcome
PFS
Time frame: From enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months
progression free survival
2 secondary outcomes
ORR
Time frame: From enrollment until date of completion of chemotherapy, assessed up to 9 months
toxicities
Time frame: from enrollment to 30 days after completion of chemotherapy, assessed up to 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Derived from this study: PubMed 42124356Li C, Lei T, Xu X, Lu J, Zhu X, Chen Z, Weng X, Yu H, Chen X, Peng S, Han S, Yang H. RCLARITY: A Prospective Phase II Study of Rituximab Combined With Lenalidomide and Chidamide (RLC) for the Treatment of Relapsed/Refractory Angioimmunoblastic T-Cell Lymphoma. Am J Hematol. 2026 May 12. doi: 10.1002/ajh.70366. Online ahead of print.
- 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. This study is not recruiting at the moment.
Ming Chen, PhD study chair
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab in people with Angioimmunoblastic T-cell Lymphoma and Chemotherapy Effect, 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 12 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Mar 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cong Li, MD (+8615267115611, licong@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months). 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 NCT04319601, which also lists 1 linked publication.
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 24 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.