Trial Outcomes & Findings for Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma (NCT NCT00596154)

NCT ID: NCT00596154

Last Updated: 2024-04-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 33 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2024-04-01

Participant Flow

Participant milestones

Measure	Newly Diagnosed Primary CBS Lymphoma/PCNSL 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. Participants will be off study at the time of death.
Overall Study STARTED	33
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Newly Diagnosed Primary CBS Lymphoma/PCNSL 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. Participants will be off study at the time of death.
Overall Study Not Evaluable	2

Baseline Characteristics

Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma

Baseline characteristics by cohort

Measure	Newly Diagnosed Primary CBS Lymphoma/PCNSL n=33 Participants 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. Participants will be off study at the time of death.
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

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.

Outcome measures

Measure	Newly Diagnosed Primary CBS Lymphoma/PCNSL n=33 Participants 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. Participants will be off study at the time of death.
Number of Participants Evaluated for Toxicity	33 Participants

SECONDARY outcome

Timeframe: after 10 weeks (5 cycles)

To evaluate response rates with the combination of rituximab and MPV as induction chemotherapy.

Outcome measures

Measure	Newly Diagnosed Primary CBS Lymphoma/PCNSL n=33 Participants 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. Participants will be off study at the time of death.
Overall Response Rates Progression Free	1 Participants
Overall Response Rates Complete Response	22 Participants
Overall Response Rates Partial Response	6 Participants
Overall Response Rates Stable Disease	1 Participants
Overall Response Rates Not Evaluable	3 Participants

Adverse Events

Newly Diagnosed Primary CBS Lymphoma/PCNSL

Serious events: 14 serious events

Other events: 33 other events

Deaths: 7 deaths

Serious adverse events

Measure	Newly Diagnosed Primary CBS Lymphoma/PCNSL n=33 participants at risk 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. Participants will be off study at the time of death.
Investigations ALT, SGPT	9.1% 3/33 • 1 year
Investigations AST, SGOT	9.1% 3/33 • 1 year
Psychiatric disorders Confusion	3.0% 1/33 • 1 year
Investigations Creatinine	3.0% 1/33 • 1 year
Gastrointestinal disorders Diarrhea	6.1% 2/33 • 1 year
General disorders Fever (in the absence of neutropenia)	3.0% 1/33 • 1 year
Infections and infestations Infection, other	9.1% 3/33 • 1 year
Hepatobiliary disorders Liver dysfunction/failure	3.0% 1/33 • 1 year
Gastrointestinal disorders Nausea	9.1% 3/33 • 1 year
Nervous system disorders Neuropathy: motor	3.0% 1/33 • 1 year
Gastrointestinal disorders Obstruction, GI- Small bowel NOS	3.0% 1/33 • 1 year
Eye disorders Ophthalmoplegia/diplopia (double vision)	3.0% 1/33 • 1 year
Musculoskeletal and connective tissue disorders Osteonecrosis (avascular necrosis)	3.0% 1/33 • 1 year
General disorders Pain - Chest/thorax NOS	3.0% 1/33 • 1 year
Nervous system disorders Pain - Head/headache	3.0% 1/33 • 1 year
Skin and subcutaneous tissue disorders Rash/desquamation	6.1% 2/33 • 1 year
Skin and subcutaneous tissue disorders Rash: erythema multiforme	6.1% 2/33 • 1 year
Nervous system disorders Seizure	3.0% 1/33 • 1 year
Vascular disorders Thrombosis/thrombus/embolism	9.1% 3/33 • 1 year
Gastrointestinal disorders Vomiting	6.1% 2/33 • 1 year
General disorders Death not related to disease	21.2% 7/33 • 1 year

Other adverse events

Measure	Newly Diagnosed Primary CBS Lymphoma/PCNSL n=33 participants at risk 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. Participants will be off study at the time of death.
General disorders Fatigue	33.3% 11/33 • 1 year
Nervous system disorders Neuropathy: sensory	21.2% 7/33 • 1 year
Gastrointestinal disorders Constipation	15.2% 5/33 • 1 year
Nervous system disorders Neuropathy: motor	12.1% 4/33 • 1 year
Gastrointestinal disorders Nausea	9.1% 3/33 • 1 year
Investigations Lymphopenia	6.1% 2/33 • 1 year
Nervous system disorders Pain - Head/headache	6.1% 2/33 • 1 year
Nervous system disorders Dysgeusia	6.1% 2/33 • 1 year

Additional Information

Dr. Christian Grommes, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-610-0344

Email: grommesc@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place