Actively Recruiting
RL-MPV Followed by BBC HCT Using Autologous Stem Cells and Maintenance Therapy With Nivolumab for Newly Diagnosed PCNSL
Led by National Research Center for Hematology, Russia · Updated on 2022-06-21
30
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the efficacy and safety of the new treatment proposed in this study. Conducting a prospective study "CNS-2015" in patients with PDLBCL CNS made it possible to achieve 2-year EFS, DFS and OS of 83%, 83% and 88%, respectively. The presence of early relapses of the disease has now led to the need to find an alternative program for patients with PDLBCL CNS. In the new "CNS-2021" protocol, lenalidomide was included in the R-MPV program in order to intensify the induction stage. In the conditioning regimen, thiotepa was replaced by carmustine, due to its significant CNS bioavailability. In order to possibly prevent early relapses, an anti-PD-1 inhibitor (nivolumab) was used as maintenance therapy.
CONDITIONS
Official Title
RL-MPV Followed by BBC HCT Using Autologous Stem Cells and Maintenance Therapy With Nivolumab for Newly Diagnosed PCNSL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of non-Hodgkin's lymphoma involving the brain confirmed by CT or MRI and histologic confirmation by positive CSF cytology, monoclonal lymphocyte population, vitreous or uvea biopsy, or brain biopsy
- HIV-1 negative status
- Left ventricular ejection fraction of 50% or higher
- No evidence of systemic lymphoma confirmed by CT scan of chest, abdomen, and pelvis
- Adequate bone marrow function: peripheral leukocyte count >3000 cells/mm3 and platelet count >100,000 cells/mm3
- Adequate liver function: bilirubin less than 2.0 mg/%
- Adequate renal function: serum creatinine less than 1.5 mg/dl or creatinine clearance greater than 50 cc/min/1.73 m2
- Men and women of reproductive potential must agree to use birth control during treatment and for six months after
- Age between 18 and 70 years
- Signed informed consent
You will not qualify if you...
- Prior cranial irradiation
- Other active primary malignancy
- Pre-existing immunodeficiency such as renal transplant recipient
- Prior chemotherapy treatment for CNS lymphoma
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nathional Medical Research Center for Hematology
Moscow, Russia, 125167
Actively Recruiting
Research Team
E
Eugene Zvonkov, Phd, MD
CONTACT
D
Daria Koroleva, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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