A Phase 2 interventional study of Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide in CNS Lymphoma, CNS Brain Cancer and Non-Hodgkin's Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 3 sites in United States. Open to participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the safety of this new treatment offered in this study. PCNSL can be cured in less than half of patients with standard treatment, a combination of chemotherapy and brain radiation. Also, the combination of chemotherapy and brain radiation may result in serious lasting side effects. Most patients older than age 60 develop memory problems, difficulty walking or inability to control their bladder. Some patients younger than age 60 also develop these side effects.
2,043 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 309 are open to participants now.
This study's enrollment of 33 is below the median of 40 across 1,744 interventional studies indexed under Lymphoma, Non-Hodgkin.
Browse Lymphoma, Non-Hodgkin studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,957 studies on the registry; 323 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 68 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma. Brain biopsy.
Exclusion Criteria:
Rituximab, methotrexate (MTX), procarbazine and vincristine (R-MPV). The peripheral blood stem cell (PBSC) harvest procedure will be performed at the discretion of the hematology attending (usually after the 1st or 2nd cycle of R-MPV)and high dose chemotherapy Busulfan, Thiotepa, and Cyclophosphamide. Patients will be off study at the time of death. All patients will be followed for survival every 6 months throughout their lifetime. Survival status may be obtained by phone call, clinical visit or medical records (e.g. physician notes/laboratory results of clinic or hospital visit.
Other: Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide
The initial treatment will consist of cycles of 14 days. Each cycle will start with rituximab, which will be given by vein on day 1. On day 2 you will be admitted to the hospital and will receive 3 other drugs: Methotrexate will be given by vein over 2 to 3 hours only on day 2. Vincristine will be given as a single injection over a few minutes only on day 2. Procarbazine is a pill that you will take at bedtime for 7 nights starting on day 2. Procarbazine is only given every other cycle.
Also known as: During each cycle, you will receive Rituximab typically as an outpatient on day 1 and then be, admitted on day 2 to receive the other chemotherapy. You will be in the hospital for about 5 days and will be re-admitted to the hospital about 9 days, later to start the next cycle. After each cycle of chemotherapy you will take a medicine called G-CSF to protect you against, infection. PBPCs will be collected when determined by your doctor and may occur with cycle 1 or cycle 2., You will be admitted again for the high-dose chemotherapy and will receive supportive, medications to help avoid complications, including antibiotics and blood transfusions. Three, drugs, Busulfan, Thiotepa, and Cyclophosphamide will be given to you over 8 days. After a, rest period of approximately 1-2 days, we will give your PBPCs (or bone marrow) back to you, by vein. You will be in the hospital for at least 3 weeks.
Number of Participants Evaluated for Toxicity
To evaluate the safety and efficacy of the use of R-MPV followed by high-dose chemotherapy using thiotepa, cyclophosphamide and busulfan with stem cell rescue in patients with newly diagnosed PCSNL.
Time frame: 1 year
Overall Response Rates
To evaluate response rates with the combination of rituximab and MPV as induction chemotherapy.
Time frame: after 10 weeks (5 cycles)
| Milestone | Newly Diagnosed Primary CBS Lymphoma/PCNSL |
|---|---|
| Started | 33 |
| Completed | 31 |
| Not completed | 2 |
| Withdrew: Not evaluable | 2 |
To evaluate the safety and efficacy of the use of R-MPV followed by high-dose chemotherapy using thiotepa, cyclophosphamide and busulfan with stem cell rescue in patients with newly diagnosed PCSNL.
| Participants | Newly Diagnosed Primary CBS Lymphoma/PCNSL |
|---|---|
| Number of Participants Evaluated for Toxicity | 33 |
To evaluate response rates with the combination of rituximab and MPV as induction chemotherapy.
| Participants | Newly Diagnosed Primary CBS Lymphoma/PCNSL |
|---|---|
| Progression Free | 1 |
| Complete Response | 22 |
| Partial Response | 6 |
| Stable Disease | 1 |
| Not Evaluable | 3 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Newly Diagnosed Primary CBS Lymphoma/PCNSL | 7/33 (21.2%) | 14/33 (42.4%) | 33/33 (100%) |
| Event | Newly Diagnosed Primary CBS Lymphoma/PCNSL |
|---|---|
| Death not related to diseaseGeneral disorders | 7/33 |
| ALT, SGPTInvestigations | 3/33 |
| AST, SGOTInvestigations | 3/33 |
| Infection, otherInfections and infestations | 3/33 |
| NauseaGastrointestinal disorders | 3/33 |
| Thrombosis/thrombus/embolismVascular disorders | 3/33 |
| DiarrheaGastrointestinal disorders | 2/33 |
| Rash/desquamationSkin and subcutaneous tissue disorders | 2/33 |
| Rash: erythema multiformeSkin and subcutaneous tissue disorders | 2/33 |
| VomitingGastrointestinal disorders | 2/33 |
| Event | Newly Diagnosed Primary CBS Lymphoma/PCNSL |
|---|---|
| FatigueGeneral disorders | 11/33 |
| Neuropathy: sensoryNervous system disorders | 7/33 |
| ConstipationGastrointestinal disorders | 5/33 |
| Neuropathy: motorNervous system disorders | 4/33 |
| NauseaGastrointestinal disorders | 3/33 |
| LymphopeniaInvestigations | 2/33 |
| Pain - Head/headacheNervous system disorders | 2/33 |
| DysgeusiaNervous system disorders | 2/33 |
| Age, Continuous(years) | Newly Diagnosed Primary CBS Lymphoma/PCNSL |
|---|---|
| Median | 57 (24 to 68) |
| Sex: Female, Male(Participants) | Newly Diagnosed Primary CBS Lymphoma/PCNSL |
|---|---|
| Female | 15 |
| Male | 18 |
| Ethnicity (NIH/OMB)(Participants) | Newly Diagnosed Primary CBS Lymphoma/PCNSL |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 33 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Newly Diagnosed Primary CBS Lymphoma/PCNSL |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 29 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Newly Diagnosed Primary CBS Lymphoma/PCNSL |
|---|---|
| United States | 33 |
Documents are hosted by the registry — open the source record to download them.
Ran from Dec 2004 to primary completion in Feb 2023, 218 months.
Results were first posted in Apr 2024, 1 year 1 month after primary completion.
Of 164 non-industry phase 2 interventional studies under Lymphoma, Non-Hodgkin, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 106. This study's 218 months is above that.
Counting every sponsor, half of 216 studies reached it within 65 months; a quarter within 41 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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