TriangleNCT00364923 · STUDY IN CONTEXT
Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Patient response to treatment was determined by independent central review using International Workshop Criteria (IWC). Results present the best overall response. The initial response assessment was scheduled at week 7 (prior to Cycle 2) and then prior to every even-numbered cycle (every 14 weeks) for up to two years after first dose.
Calculated only for those pts with an objective response. Pts receiving subsequent therapy (including transplant) before progressive disease (PD) was documented were censored at date of last response assessment obtained prior to subsequent therapy, with a note indicating censoring occurrence \& reason. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last evaluable assessment of response. Pts who withdrew from treatment prior to PD or initiation of subsequent therapy without withdrawing consent were followed for disease status when possible.
Patients (pts) with subsequent therapy prior to PD were censored at date of last response assessment prior to subsequent therapy. Pts who were alive without PD were censored at the date of last assessment of first dose. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last disease assessment or treatment day 1. Pts who withdrew consent from treatment prior to PD without withdrawing consent for follow-up were followed for disease status \& survival. Pts who did not have response assessments after baseline were censored at treatment day 1.
Calculated as date of death - date of enrollment +1, estimated using the product-limit estimator. Pts who had not died (no record of death) or were lost to follow-up were censored at the date of last contact. Pts who withdrew consent to participate in the study including consent to be followed, were censored on the date of withdrawal. Pts who withdrew from treatment without withdrawing consent were followed for survival status whenever possible.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-riabni-7424044e
- nct id
- NCT00364923
- trial label
- Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
- applicability
- unclear
- applicability note
- Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-riabni-7424044e
- nct id
- NCT00364923
- outcome key
- om-0000
- source section id
- NCT00364923-om-0000
- source outcome index
- 0
- endpoint
- Response Rate Per Independent Central Review
- endpoint definition
- Patient response to treatment was determined by independent central review using International Workshop Criteria (IWC). Results present the best overall response. The initial response assessment was scheduled at week 7 (prior to Cycle 2) and then prior to every even-numbered cycle (every 14 weeks) for up to two years after first dose.
- time origin
- Response was assessed at 7 weeks (prior to Cycle 2) and then prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Analysis was per protocol and was based on number of patients (pts) who responded in the evaluable population. The evaluable population consisted of all pts who received at least one dose of pralatrexate and had an eligible peripheral T-cell lymphoma (PTCL) histopathological subtype confirmed by central pathology review.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-riabni-7424044e
- nct id
- NCT00364923
- outcome key
- om-0001
- source section id
- NCT00364923-om-0001
- source outcome index
- 1
- endpoint
- Duration of Response Per Independent Central Review
- endpoint definition
- Calculated only for those pts with an objective response. Pts receiving subsequent therapy (including transplant) before progressive disease (PD) was documented were censored at date of last response assessment obtained prior to subsequent therapy, with a note indicating censoring occurrence \& reason. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last evaluable assessment of response. Pts who withdrew from treatment prior to PD or initiation of subsequent therapy without withdrawing consent were followed for disease status when possible.
- time origin
- Measured from the first day of documented response, assessed at prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Analysis was per protocol. Based on the number of responding pts (n=32) in the evaluable population (n=109), as assessed by independent central review protocol.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-riabni-7424044e
- nct id
- NCT00364923
- outcome key
- om-0002
- source section id
- NCT00364923-om-0002
- source outcome index
- 2
- endpoint
- Progression-free Survival Per Independent Central Review
- endpoint definition
- Patients (pts) with subsequent therapy prior to PD were censored at date of last response assessment prior to subsequent therapy. Pts who were alive without PD were censored at the date of last assessment of first dose. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last disease assessment or treatment day 1. Pts who withdrew consent from treatment prior to PD without withdrawing consent for follow-up were followed for disease status \& survival. Pts who did not have response assessments after baseline were censored at treatment day 1.
- time origin
- Calculated as the number of days from treatment day 1 to the date of disease progression or death, regardless of cause for up to 2 years after initial dose
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored. Pts were censored for lack of PD, receipt of other anti-cancer therapy before PD, termination of study/follow-up for response, and transplant.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-riabni-7424044e
- nct id
- NCT00364923
- outcome key
- om-0003
- source section id
- NCT00364923-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival Per Independent Central Review
- endpoint definition
- Calculated as date of death - date of enrollment +1, estimated using the product-limit estimator. Pts who had not died (no record of death) or were lost to follow-up were censored at the date of last contact. Pts who withdrew consent to participate in the study including consent to be followed, were censored on the date of withdrawal. Pts who withdrew from treatment without withdrawing consent were followed for survival status whenever possible.
- time origin
- Assessed every 14 weeks while on treatment, and after disease progression no less frequently than every 6 months for up to 2 years after first dose.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Analysis was per protocol, based on the number of patients (pts) who had an event (death or censoring) at the time of data cut-off.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-riabni-7424044e
- nct id
- NCT00364923
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Evaluable Population
- regimen
- All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
- analyzed count
- 109
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00364923-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-riabni-7424044e
- nct id
- NCT00364923
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Evaluable Population
- regimen
- All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00364923-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-riabni-7424044e
- nct id
- NCT00364923
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Evaluable Population
- regimen
- All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
- analyzed count
- 109
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00364923-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-riabni-7424044e
- nct id
- NCT00364923
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Evaluable Population
- regimen
- All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
- analyzed count
- 109
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00364923-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-riabni-7424044e
- nct id
- NCT00364923
- harm key
- EG000
- source section id
- NCT00364923-ae
- event group key
- EG000
- event group label
- Full Population
- serious affected
- 50
- serious at risk
- 111
- other affected
- 111
- other at risk
- 111
- frequency threshold
- 5
- collection period
- All adverse events (AEs) were captured from the first dose of pralatrexate through 30 days after the last study treatment. From 31 days after the last dose of pralatrexate, pralatrexate-related AEs were recorded until the start of subsequent therapy.
- event definition
- Serious AEs and AEs regardless of causality and all grades presented below. Symptoms present at baseline, AEs, and intercurrent illnesses were monitored at every study visit. Patients were instructed to report AEs to the investigator. All AEs including observed or volunteered problems, complaints, or symptoms were recorded.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice