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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04934579
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
83.4
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety Study of Rituximab, Methotrexate and Lenalidomide Chemotherapy(R2-MTX) in Newly Diagnosed Primary Central Nervous System Lymphoma:a Single Arm, Multicenter, Phase 2 Study
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 12, 2023
Anticipated Study Completion Date :
Dec 12, 2026

Arms and Interventions

ArmIntervention/Treatment
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
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.

Drug: Lenalidomide
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.

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

Outcome Measures

Primary Outcome Measures

  1. Objective response rate(ORR) [At the end of Cycle 6 chemotheray (each cycle is 21 days), assessed up to 18 weeks.]

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

Secondary Outcome Measures

  1. Progression free survival [3 years]

    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

  2. Overall survival [3 years]

    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

  3. Treatment-related adverse events [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
12nd Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhouZhejiangChina310009

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04934579
Other Study ID Numbers:
  • I2021001531
First Posted:
Jun 22, 2021
Last Update Posted:
Jun 22, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2021