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Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma

Primary Purpose

Primary Central Nervous System Lymphoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Rituximab

Lenalidomide

Methotrexate

Temozolomide

About this trial

This is an interventional treatment trial for Primary Central Nervous System Lymphoma focused on measuring Primary Central Nervous System Lymphoma, RL-MT

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age between 18 to 70 years old (including 18 and 70)
Diagnosed as primary central nervous system lymphoma (limited to the brain, spinal cord, meninges and eyeballs, without involvement of other parts)
Having not received anti-tumor therapy before enrollment (except for tumor resection and biopsy and the use of glucocorticoids to reduce central nervous system symptoms)
Having at least one measurable lesions
World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)
Life expectancy no less than 1 month
enough main organ function
Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
Agreeing to sign the written informed consents

Exclusion Criteria:

Diagnosed as secondary central nervous system lymphoma
Diagnosed as CD20 negative large B cell primary central nervous system lymphoma
Active malignant tumor need be treated at the same time
Other malignant tumor history
Serious surgery and trauma less than two weeks
Patients with active tuberculosis
Systemic therapy for serious acute/chronic infection
Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
HIV-positive, AIDS patients and untreated active hepatitis
Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
Patients with a history of mental illness or drug abuse
Poor compliance during the trial and/or follow-up phase
Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial
Researchers determine unsuited to participate in this trial

Sites / Locations

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RL-MT

Arm Description

Induction Chemotherapy: Rituximab, 375mg/m2, Intravenous administration on day 0, Lenalidomide, 25mg oral administration on day 1 to 10, combined with regimen: Methotrexate, 3mg/m2, Intravenous administration (pumping for 3h) on day 1 of each 3-week cycle, Temozolomide, 150mg/m2/d oral administration on day 1 to 10. Consolidation Treatment: Autologous hematopoietic stem cell transplantation or reduced whole brain radiotherapy after high-dose chemotherapy. Maintenance Treatment: Lenalidomide, 10mg oral administration on day 1 to 21 of each 4-week cycle for 12 months.

Outcomes

Primary Outcome Measures

2-year progression-free survival

the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first

Secondary Outcome Measures

objective response rate

the total proportion of patients with complete response (CR) and partial response (PR)

overall survival

from date of first day of treatment to the date of death by any cause

incidence and relationship with study drugs of grade 3-4 adverse events

the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03)

Full Information

NCT ID

NCT04737889

First Posted

January 30, 2021

Last Updated

May 17, 2023

Sponsor

Henan Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04737889

Brief Title

Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma

Official Title

A Single Arm, Multi-center, Phase II Clinical Trial of Rituximab, Lenalidomide Combined With High-dose Methotrexate and Temozolomide (RL-MT) in the First-line Treatment for Patients With Primary Central Nervous System Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 13, 2021 (Actual)

Primary Completion Date

January 13, 2024 (Anticipated)

Study Completion Date

January 13, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of Rituximab, Lenalidomide combined with high-dose Methotrexate and Temozolomide (RL-MT) in the first-line treatment for patients with primary central nervous system lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Central Nervous System Lymphoma

Keywords

Primary Central Nervous System Lymphoma, RL-MT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RL-MT

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Rituximab

Other Intervention Name(s)

RiTUXimab Injection

Intervention Description

Induction Chemotherapy: 375mg/m2, Intravenous administration on day 0 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

Lenalidomide capsule

Intervention Description

Induction Chemotherapy: 25mg, oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles. Maintenance Treatment: 10mg oral administration on day 1 to 21 repeated every 4 weeks until disease progression or unacceptable toxicity develops, up to 12 cycles.

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Other Intervention Name(s)

Methotrexate Injectable Solution

Intervention Description

Induction Chemotherapy: 3mg/m2, Intravenous administration (pumping for 3h) on day 1 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

Temozolomide capsule

Intervention Description

Induction Chemotherapy: 150mg/m2/d oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.

Primary Outcome Measure Information:

Title

2-year progression-free survival

Description

the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first

Time Frame

from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 21 days)

Secondary Outcome Measure Information:

Title

objective response rate

Description

the total proportion of patients with complete response (CR) and partial response (PR)

Time Frame

every 6 weeks from the day of the first cycle of induction chemotherapy treatment and every 8 weeks from the day of the first cycle of maintenance treatment to 18 months after last patient's enrollment (each cycle is 21 days)

Title

overall survival

Description

from date of first day of treatment to the date of death by any cause

Time Frame

from date of the first cycle of treatment to the date of death from any cause, assessed up to 5 years (each cycle is 21 days)

Title

incidence and relationship with study drugs of grade 3-4 adverse events

Description

the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03)

Time Frame

from the date of the first cycle of treatment to 18 months after last patient's enrollment (each cycle is 21 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 18 to 70 years old (including 18 and 70) Diagnosed as primary central nervous system lymphoma (limited to the brain, spinal cord, meninges and eyeballs, without involvement of other parts) Having not received anti-tumor therapy before enrollment (except for tumor resection and biopsy and the use of glucocorticoids to reduce central nervous system symptoms) Having at least one measurable lesions World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator) Life expectancy no less than 1 month enough main organ function Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study Agreeing to sign the written informed consents Exclusion Criteria: Diagnosed as secondary central nervous system lymphoma Diagnosed as CD20 negative large B cell primary central nervous system lymphoma Active malignant tumor need be treated at the same time Other malignant tumor history Serious surgery and trauma less than two weeks Patients with active tuberculosis Systemic therapy for serious acute/chronic infection Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months HIV-positive, AIDS patients and untreated active hepatitis Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months Patients with a history of mental illness or drug abuse Poor compliance during the trial and/or follow-up phase Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial Researchers determine unsuited to participate in this trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhihua Yao, M.D. Ph.D

Phone

+8613592622292

zlyyyaozhihua1260@zzu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yanyan Liu, M.D. Ph.D

Phone

+8613838176375

yyliu@zzu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhihua Yao, M.D. Ph.D

Organizational Affiliation

Henan Cancer Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Yanyan Liu, M.D. Ph.D

Organizational Affiliation

Henan Cancer Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

City

Zhengzhou

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhihua Yao, M.D. Ph.D

Phone

+8613592622292

zlyyyaozhihua1260@zzu.edu.cn

First Name & Middle Initial & Last Name & Degree

Yanyan Liu, M.D. Ph.D

Phone

+8613818176375

yyliu@zzu.edu.cn

First Name & Middle Initial & Last Name & Degree

Zhihua Yao, M.D. Ph.D

First Name & Middle Initial & Last Name & Degree

Yanyan Liu, M.D. Ph.D

12. IPD Sharing Statement

Learn more about this trial

Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma

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