Trial · NCT03349333
A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL
NCT03349333, Phase 3, Completed, Mundipharma (China) Pharmaceutical Co. Ltd; results first posted 2019-09-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL. Trials, record NCT03349333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03349333
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL
- NCT number
- NCT03349333
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 85 participants, actual
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Conditions
- Refractory Peripheral T-Cell Lymphoma, Relapsed T-Cell Lymphoma
- Interventions
- pralatrexate, Vitamin B12 and folic acid
- First posted
- 2017-11-21
- Last updated
- 2019-10-01
- Results first posted
- 2019-09-12
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate(ORR) by International Working Group Criteria | 2 years | ORR defined as the percentage of subjects with CR, CRu or PR as Best Overall Response.Evaluation of response must be performed within 7 days prior to the projected first dose of cycle 2-4 and then within 7 days prior to the projected first dose of every even-numbered subsequent cycle (i.e. prior to cycles 6, 8, etc). Unscheduled radiological response assessments will be performed earlier if clinical progression is suspected.The primary analysis will be conducted once all subjects have completed cycle 5 treatment or discontinued before. Study treatment may continue per investigator judgment for a maximum of 24 months. Response will be assessed on the basis of clinical, radiological, and pathological criteria. Response will be assessed by independent central review and by the treating investigator. Central review assessors will be blinded to the response assessments by the treating investigator. The primary analysis will be based on response assessed by central review. |
| Secondary | Time to Response (TTR) | 2 years | Time to response was measured from first day of treatment to the first date of documented response. |
| Secondary | Progression-Free Survival (PFS) | 2 years | PFS was measured from treatment day 1 until event or censoring. An event was defined as the earliest of the following: death from any cause or disease progression. Subjects undergoing transplant or any other subsequent therapy prior to documentation of PD was censored at that time. Progression of disease deems as 1. 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders, 2.Appearance of any new lesion during or at the end of therapy as per IWC criteria. |
| Secondary | Overall Survival (OS) | 4 years | OS was measured from treatment day 1 until death or censoring. |
| Secondary | Duration of Responses | 4 years | Duration of response was measured from first day of documented response to disease progression or death, whatever comes first. |
| Secondary | Percentage of Participants With Treatment Emergent Adverse Events | 4 years | treatment emergent AE was scheduled to be collected during all subject visits, the data evaluated as clinical significant will be summarized and presented. |
| Secondary | Area Under the Curve [AUC] for R-pralatrexate | Cycle 1 day1，Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection) | The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. |
| Secondary | Area Under the Curve [AUC] for S-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. |
| Secondary | Steady State Volume of Distribution [Vdss] for R-pralatrexate | Cycle 1 day 1, Cycle 1 week6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection) | The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. |
| Secondary | Steady State Volume of Distribution [Vdss] for S-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate(ORR) by International Working Group Criteria | 2 years | The primary analysis was based on the independent review data using the safety population, safety population is 71 for this study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Response (TTR) | 2 years | The secondary analyses was performed using the safety population and repeated using the per-protocol population. | months | MEAN |
| SECONDARY | Progression-Free Survival (PFS) | 2 years | The secondary analyses was performed using the safety population and repeated using the per-protocol population. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 4 years | The secondary analyses was performed using the safety population and repeated using the per-protocol population. | months | MEDIAN |
| SECONDARY | Duration of Responses | 4 years | The secondary analyses was performed using the safety population and repeated using the per-protocol population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Treatment Emergent Adverse Events | 4 years | safety population | percentage of participants | NUMBER |
| SECONDARY | Area Under the Curve [AUC] for R-pralatrexate | Cycle 1 day1，Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection) | Based on PK population | h*ng/ml | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve [AUC] for S-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | PK population | h*ng/ml | GEOMETRIC_MEAN |
| SECONDARY | Steady State Volume of Distribution [Vdss] for R-pralatrexate | Cycle 1 day 1, Cycle 1 week6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection) | PK population | L | MEAN |
| SECONDARY | Steady State Volume of Distribution [Vdss] for S-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | PK population | L | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate(ORR) by International Working Group Criteria | Pralatrexate | 37 | Participants | ||
| Time to Response (TTR) | Pralatrexate | 2.0947 | Standard Deviation 1.6590 | months | |
| Progression-Free Survival (PFS) | Pralatrexate | 4.76 | 95% Confidence Interval 3.06 to 8.75 | months | |
| Overall Survival (OS) | Pralatrexate | 18.00 | 95% Confidence Interval 10.35 to NA | months | |
| Duration of Responses | Pralatrexate | 8.67 | 95% Confidence Interval 3.32 to 14.13 | months | |
| Percentage of Participants With Treatment Emergent Adverse Events | Pralatrexate | 98.6 | percentage of participants | ||
| Area Under the Curve [AUC] for R-pralatrexate | Pralatrexate | Pralatrexate-R in Cycle 1 week 6（20mg/m2） | 2350.7402 | Geometric Coefficient of Variation 28.22 | h*ng/ml |
| Area Under the Curve [AUC] for R-pralatrexate | Pralatrexate | Pralatrexate-R in Cycle 1 week 6（30mg/m2） | 3979.1069 | Geometric Coefficient of Variation 152.16 | h*ng/ml |
| Area Under the Curve [AUC] for R-pralatrexate | Pralatrexate | Pralatrexate-R in Cycle 1 day 1（30mg/m2） | 3586.2925 | Geometric Coefficient of Variation 43.70 | h*ng/ml |
| Area Under the Curve [AUC] for S-pralatrexate | Pralatrexate | Pralatrexate-S in Cycle 1 week 6（20mg/m2） | 1364.7686 | Geometric Coefficient of Variation 22.65 | h*ng/ml |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pralatrexate | 71 | |
| Overall Study | COMPLETED | Pralatrexate | 0 | |
| Overall Study | NOT COMPLETED | Pralatrexate | 71 |
Source ClinicalTrials.gov
Adverse events11
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Stomatitis | Gastrointestinal disorders | Pralatrexate | 48 | 71 | 101 |
| other | Neutropenia | Blood and lymphatic system disorders | Pralatrexate | 22 | 71 | 50 |
| serious | Lung infection | Infections and infestations | Pralatrexate | 7 | 71 | 8 |
| serious | Platelet count decreased | Investigations | Pralatrexate | 10 | 71 | 13 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Pralatrexate | 4 | 71 | 4 |
| serious | Stomatitis | Gastrointestinal disorders | Pralatrexate | 3 | 71 | 3 |
| serious | Pneumonia | Infections and infestations | Pralatrexate | 4 | 71 | 5 |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Pralatrexate | 3 | 71 | 3 |
| serious | Pancytopenia | Blood and lymphatic system disorders | Pralatrexate | 2 | 71 | 2 |
| serious | Hepatic function abnormal | Hepatobiliary disorders | Pralatrexate | 1 | 71 | 1 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pralatrexate | 29 | 71 |
| Total, other adverse events | Pralatrexate | 70 | 71 |
| Total, serious adverse events | Pralatrexate | 35 | 71 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30904980 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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