TriangleNCT00267865 · OUTCOME
Number of Participants With Response to Treatment After Rituximab, High-Dose Methotrexate (R-HD-MTX) Induction
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- At the end of 6 cycles or 12 weeks of treatment
What was measured
Response was assessed by the International Workshop Criteria for Non-Hodgkin's Lymphoma. Complete Response is disappearance of all enhancing lesions on magnetic resonance imaging of the brain. Partial Response is a reduction of enhancing tumor volume by more than 50% for at least 4 weeks. Progressive Disease is an increase of tumor volume of more than 25% or occurrence of new lesions.
Analysis population: Two participants were not evaluable. One participant received one cycle of therapy and one was not evaluable due to treatment failure.
Groups in this outcome
Rituximab, High-Dose Methotrexate & Leucovorin Treatment
Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
| Group | Source count |
|---|---|
| Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 10 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 5 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 4 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 4
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Progressive Disease
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- description
- Response was assessed by the International Workshop Criteria for Non-Hodgkin's Lymphoma. Complete Response is disappearance of all enhancing lesions on magnetic resonance imaging of the brain. Partial Response is a reduction of enhancing tumor volume by more than 50% for at least 4 weeks. Progressive Disease is an increase of tumor volume of more than 25% or occurrence of new lesions.
- groups
- description
- Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
- id
- OG000
- title
- Rituximab, High-Dose Methotrexate & Leucovorin Treatment
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Two participants were not evaluable. One participant received one cycle of therapy and one was not evaluable due to treatment failure.
- reporting Status
- POSTED
- time Frame
- At the end of 6 cycles or 12 weeks of treatment
- title
- Number of Participants With Response to Treatment After Rituximab, High-Dose Methotrexate (R-HD-MTX) Induction
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice