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

Primary Central Nervous System Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04737889
• Other study ID #: HNSZLYYNHL04
• Status: Recruiting
• Phase: Phase 2
• Start date: January 13, 2021
• Est. completion date: January 13, 2026

Study information

• Verified date: May 2023
• Source: Henan Cancer Hospital
• Contact: Zhihua Yao, M.D. Ph.D
• Phone: +8613592622292
• Email: zlyyyaozhihua1260[@]zzu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 13, 2026
• Est. primary completion date: January 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age between 18 to 70 years old (including 18 and 70)

2. Diagnosed as primary central nervous system lymphoma (limited to the brain, spinal cord, meninges and eyeballs, without involvement of other parts)

3. 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)

4. Having at least one measurable lesions

5. 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)

6. Life expectancy no less than 1 month

7. enough main organ function

8. 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

9. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Diagnosed as secondary central nervous system lymphoma

2. Diagnosed as CD20 negative large B cell primary central nervous system lymphoma

3. Active malignant tumor need be treated at the same time

4. Other malignant tumor history

5. Serious surgery and trauma less than two weeks

6. Patients with active tuberculosis

7. Systemic therapy for serious acute/chronic infection

8. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months

9. HIV-positive, AIDS patients and untreated active hepatitis

10. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months

11. Patients with a history of mental illness or drug abuse

12. Poor compliance during the trial and/or follow-up phase

13. Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial

14. Researchers determine unsuited to participate in this trial

Related Conditions & MeSH terms

• Lymphoma
• Primary Central Nervous System Lymphoma

Intervention

Drug:
• Rituximab
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.
• Lenalidomide
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.
• Methotrexate
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.
• Temozolomide
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.

Locations

Country	Name	City	State
China	Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	objective response rate	the total proportion of patients with complete response (CR) and partial response (PR)	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)
Secondary	overall survival	from date of first day of treatment to the date of death by any cause	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)
Secondary	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)	from the date of the first cycle of treatment to 18 months after last patient's enrollment (each cycle is 21 days)