Trial Outcomes & Findings for Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma (NCT NCT00594815)
NCT ID: NCT00594815
Last Updated: 2017-04-06
Results Overview
The toxicity of this combined regimen will be measured using the NCI CTC version 2.0.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
2 years
Results posted on
2017-04-06
Participant Flow
Protocol Open to Accrual 08/08/2002 Protocol Closed to Accrual 03/10/2009 Primary Completion Date 02-23-2016 Recruitment Location is the medical clinic
Participant milestones
| Measure |
Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
|
|---|---|
|
Overall Study
Never Treated
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Toxicity
|
4
|
Baseline Characteristics
Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
Baseline characteristics by cohort
| Measure |
Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
n=52 Participants
Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=99 Participants
|
|
Age, Continuous
|
60 Years
n=99 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe toxicity of this combined regimen will be measured using the NCI CTC version 2.0.
Outcome measures
| Measure |
Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
n=52 Participants
Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
|
|---|---|
|
Total Number of Participants Who Experienced Acute Treatment Related Adverse Events
|
52 Participants
|
PRIMARY outcome
Timeframe: 2 YearsOverall Progression Free Survival at 2 years
Outcome measures
| Measure |
Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
n=52 Participants
Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
|
|---|---|
|
Progression Free Survival
|
57 percentage of participants
Interval 44.0 to 71.0
|
Adverse Events
Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
Serious events: 22 serious events
Other events: 43 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
n=52 participants at risk
This is a single-armed pilot study designed to evaluate the safety and efficacy of combined immunochemotherapy followed by reduced dose radiation for participants with newly diagnosed PCNSL.
|
|---|---|
|
General disorders
Fever
|
3.8%
2/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Infections and infestations
Infection
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Blood and lymphatic system disorders
Leukocytes
|
7.7%
4/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Psychiatric disorders
Mood alteration-anxiety
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Psychiatric disorders
Hallucinations
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Cardiac disorders
Hypotension
|
3.8%
2/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Infections and infestations
Infection without neutropenia
|
7.7%
4/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Nervous system disorders
Ataxia
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Renal and urinary disorders
Elevated Creatinine
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Gastrointestinal disorders
Dehydration
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Infections and infestations
Febrile neutropenia
|
5.8%
3/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Psychiatric disorders
Mood alteration - depression
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Gastrointestinal disorders
Radiation mucositis
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Nervous system disorders
Neurology, other
|
3.8%
2/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Investigations
Neutrophils/granulocytes
|
7.7%
4/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
General disorders
Pain, other
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Psychiatric disorders
Personality/behavior
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Investigations
Platelets
|
7.7%
4/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary, other
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Renal and urinary disorders
Renal failure
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Renal and urinary disorders
Renal/GU, other
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Vascular disorders
Thrombosis
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Eye disorders
Vision-double vision
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Infections and infestations
Wound, infectious
|
5.8%
3/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
Other adverse events
| Measure |
Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
n=52 participants at risk
This is a single-armed pilot study designed to evaluate the safety and efficacy of combined immunochemotherapy followed by reduced dose radiation for participants with newly diagnosed PCNSL.
|
|---|---|
|
Metabolism and nutrition disorders
Hypocalcemia
|
69.2%
36/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
69.2%
36/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Blood and lymphatic system disorders
Hemoglobin/Anemia
|
63.5%
33/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Immune system disorders
Leukocytes
|
59.6%
31/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Investigations
SGPT (ALT)
|
46.2%
24/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Immune system disorders
Lymphopenia
|
57.7%
30/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Investigations
Neutrophils/granulocytes
|
42.3%
22/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Investigations
SGOT (AST)
|
30.8%
16/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Investigations
Platelets
|
26.9%
14/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
19.2%
10/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Investigations
PT
|
17.3%
9/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.4%
8/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.5%
7/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.5%
7/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Investigations
PTT
|
11.5%
6/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Renal and urinary disorders
Creatinine
|
11.5%
6/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Gastrointestinal disorders
Constipation
|
9.6%
5/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Hepatobiliary disorders
Bilirubin
|
9.6%
5/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.7%
4/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
General disorders
Fatigue
|
7.7%
4/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.8%
3/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
|
Nervous system disorders
Neuropathy-sensory
|
5.8%
3/52 • Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
|
Additional Information
Dr. Antonio Omuro
Memorial Sloan Kettering Cancer Center
Phone: 212-639-7523
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place