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CompletedNCT04934579Updated Nov 23, 2022

Rituximab,Methotrexate and Lenalidomide in Newly Diagnosed Primary Central Nervous System Lymphoma

A Phase 2 interventional study of Rituximab and Lenalidomide in Primary Central Nervous System Lymphoma, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-23.

Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jan 2020, registered Jun 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

It is a single arm, multicenter, phase 2 study to explore the efficacy and safety study of R2-MTX chemotherapy(Lenalidomide, Rituximab and Methotrexate)as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma. Objective response rate is the primary endpoint.

Read the detailed description

This is a single arm, multicenter, phase 2 study designed to evaluate the efficacy and safety of rituximab, methotrexate and lenalidomide as first-line regimens in the treatment of newly primary central nervous system lymphoma. A total of 40 patients plan to participate in this study to receive a total 6 cycles of induction chemotherapy followed by 4 cycles of maintenance chemotherapy. Follow-ups should be taken up to the first 3 years. The primary endpoint is objective response rate (ORR) and secondary endpoint includes Progression free survival (PFS), overall survival (OS), and adverse events.

02

Conditions studied

  • Primary Central Nervous System Lymphoma
03

In context

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 90 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Histologically confirmed Primary Central Nervous System (CNS) lymphoma
  2. Age range 18-75 years old.
  3. Eastern Cooperative Oncology Group performance status 0 to 3.
  4. Previously untreated. Patients treated with steroid alone are eligible.
  5. Patient's who are not planned to undergo consolidation with autologous hematopoietic stem cell transplantation(HSCT).
  6. Measurable disease was defined as at least ≥1.0cm in short-diameter by MRI.
  7. Life expectancy of ≥ 3 months (in the opinion of the investigator).
  8. Participants must be able to understand and be willing to sign a written informed consent document.
  9. Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 6 months after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 6 months after the last dose.
  10. Women of childbearing potential must have a negative plasma pregnancy test upon study entry.
  11. Adequate renal function: Estimated glomerular filtration rate (GFR) or estimated creatinine clearance (CrCl) ≥ 50 mL/min;Serum creatinine ≤ 2 times the upper limit of normal.
  12. Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value \& Bilirubin \< 2 X upper normal value.
  13. Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL.

Exclusion criteria

Exclusion Criteria:

  1. Patient with systemic, non-CNS lymphoma metastatic to the CNS.
  2. Patient is concurrently using other approved or investigational antineoplastic agents.
  3. Presence of active hepatitis B virus(HBV) infection (HBsAg positive and HBV-DNA≥ 104), hepatitis C virus(HCV) infection, acquired and congenital immunodeficiency diseases include but not limited to HIV.
  4. Patient is allergic to components of the study drug.
  5. Patient has an active concurrent malignancy requiring active therapy.
  6. Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, uncontrolled congestive heart failure, uncontrolled hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening.
  7. Patient is known to have an uncontrolled active systemic infection.
  8. Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk.
  9. Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive plasma human chorionic gonadotropin(hCG) laboratory test of > 5 mIU/mL.
  10. The patient is unwell or unable to participate in all required study evaluations and procedures.
  11. Drug abuse, medical, psychological or social conditions which may interfering with subjects' participation in the study or evaluation of the results.
  12. Patients considered unsuitable to participate in the study by the researchers.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    R2-MTX

    Experimental arm will be treated with R2-MTX regimen(Lenalidomide plus Rituximab and Methotrexate) for 6 cycles as initiate induction.If the patients achieved complete remission(CR)or partial remission(PR)with additional whole-brain radiotherapy(WBRT), they processed to R2 maintenance(Lenalidomide plus Rituximab) for 4 cycles.

    Drug: Rituximab · Drug: Lenalidomide · Drug: Methotrexate

Interventions

  • 375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 375mg/m2 intravenous infusion d1, every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.

  • 25mg orally d1-10 every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 25mg orally d1-14,d29-42 every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.

  • 3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 6 cycles will be prescribed.

06

What researchers measure

Primary outcomes

  1. Objective response rate(ORR)

    The objective response rate is defined as the proportion of patients with a response of complete response(CR) or partial response(PR).

    Time frame: At the end of Cycle 6 chemotherapy (each cycle is 21 days), assessed up to 18 weeks.

Secondary outcomes

  1. Progression free survival

    From date of patients sign informed consent until the date of progression or death or the date of last follow-up time, whichever came first, assessed up to 3 years

    Time frame: 3 years

  2. Overall survival

    From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 3 years

    Time frame: 3 years

  3. Treatment-related adverse events

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 1 year

07

Study locations

1 site
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310009, China
08

References and documents

Publications

  • Yuan X, Xie Y, Xu N, Liu H, Chen P, Zhao A, Liang Y, Qian W. Lenalidomide, rituximab, and methotrexate are effective in newly diagnosed primary central nervous system lymphoma. Haematologica. 2024 Jun 1;109(6):2005-2009. doi: 10.3324/haematol.2023.284834. No abstract available. PubMed 38356447 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04934579
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Responsible party
Sponsor
First posted
Jun 22, 2021
Start date
Jan 1, 2020
Primary completion
Oct 15, 2022
Completion
Nov 15, 2022
Last update
Nov 23, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Rituximab · Lenalidomide · Methotrexate

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