Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHenan Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Rituximab
DrugInduction 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
DrugInduction 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
DrugInduction 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
DrugInduction 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: RL-MTExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
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
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 outcomes
1
objective response rate
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)2
overall survival
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)3
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)
Time frame
from the date of the first cycle of treatment to 18 months after last patient's enrollment (each cycle is 21 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov