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New treatment option for Primary Central Nervous System Lymphoma
Official title Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma
ClinicalTrials.gov ID: NCT04737889
What this study is testing
What is Rituximab?
Rituximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary central nervous system lymphoma.
Also referred to as RiTUXimab Injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.