Trial · NCT01420679
Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients
NCT01420679, Phase 3, Terminated, Spectrum Pharmaceuticals, Inc; results first posted 2021-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients. Trials, record NCT01420679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01420679
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients
- NCT number
- NCT01420679
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 21 participants, actual
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Conditions
- Peripheral T-cell Lymphoma
- Interventions
- Pralatrexate Injection
- First posted
- 2011-08-22
- Last updated
- 2021-11-19
- Other registries' IDs
- eudract:2010-022230-81
- Results first posted
- 2021-11-19
- Limitations and caveats
The study was prematurely terminated due to business reasons. There were no safety concerns that led to study closure. No efficacy assessments and analysis was conducted. A full statistical analysis and report were not completed.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | From randomization to the date of progression of disease or death due to any cause (up to 76 months) | PFS was defined as the time in days from randomization to the date of objective documentation of progressive disease (PD) or death, regardless of cause (date of PD or death - date of randomization + 1). PFS was to be assessed according to the International Workshop Criteria (IWC) without including positron emission tomography (PET). PD was defined as any new lesion or increase by greater than or equal to (\>=) 50 percent (%) of previously involved sites from nadir. Participants who were alive without a disease response assessment of PD was to be censored at their last disease assessment date or the date of randomization, whichever was later. Date of progression was not to be imputed for participants with missing tumor assessments before an assessment of PD. Participants who withdraw from treatment prior to PD were to be followed for disease status whenever possible. Participants who have no response assessments after baseline were to be censored at randomization. |
| Primary | Overall Survival (OS) | From randomization until death (up to 76 months) | Overall survival was defined as the time in days from randomization to the date of death, regardless of cause (date of death - date of randomization + 1). |
| Secondary | Objective Response Rate | Up to 2 years | Objective response rate was defined as percentage of participants with an objective response of complete response (CR) or partial response (PR), relative to disease status at the time of study entry. The percentage was to be calculated by dividing number of participants within each category of response by the number of participants with measurable disease at baseline. Objective response was assessed according to the IWC without including PET. CR was defined as complete disappearance all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR was defined as regression of measurable disease and no new sites. |
| Secondary | Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities | From first dose of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. AE included both serious and non- SAEs. An AE of "Hematology and Chemistry" was collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening and Grade 4 refers to life-threatening consequences. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | From randomization to the date of progression of disease or death due to any cause (up to 76 months) | Data for this outcome measure was not collected and analyzed due to the early termination of the study. | ||
| PRIMARY | Overall Survival (OS) | From randomization until death (up to 76 months) | ITT population included all randomized participants classified according to the treatment arms into which they were randomized, regardless of the actual study treatment received (or not received). | months | MEDIAN |
| SECONDARY | Objective Response Rate | Up to 2 years | Data for this outcome measure was not collected and analyzed due to early termination of the study. | ||
| SECONDARY | Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities | From first dose of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years) | Safety population included all randomized participants classified according to the actual study treatment received, regardless of random assignment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Pralatrexate Arm | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | Observation Arm | NA | 95% Confidence Interval NA to NA | months | |
| Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities | Pralatrexate Arm | Participants with Any Treatment Emergent AEs | 14 | Participants | |
| Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities | Observation Arm | Participants with Any Treatment Emergent AEs | 6 | Participants | |
| Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities | Pralatrexate Arm | Participants with Any Grade 3 - 4 AEs | 8 | Participants | |
| Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities | Observation Arm | Participants with Any Grade 3 - 4 AEs | 2 | Participants | |
| Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities | Pralatrexate Arm | Participants with Treatment Emergent AEs Resulting in Deaths | 1 | Participants | |
| Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities | Observation Arm | Participants with Treatment Emergent AEs Resulting in Deaths | 0 | Participants | |
| Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities | Pralatrexate Arm | Participants with Treatment Emergent SAEs | 4 | Participants | |
| Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities | Observation Arm | Participants with Treatment Emergent SAEs | 0 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pralatrexate Arm | 14 | |
| Overall Study | STARTED | Observation Arm | 7 | |
| Overall Study | COMPLETED | Pralatrexate Arm | 0 | |
| Overall Study | COMPLETED | Observation Arm | 0 | |
| Overall Study | NOT COMPLETED | Pralatrexate Arm | 14 | |
| Overall Study | NOT COMPLETED | Observation Arm | 7 |
Source ClinicalTrials.gov
Adverse events290
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 | Anaemia | Blood and lymphatic system disorders | Pralatrexate Arm | 1 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | Observation Arm | 0 | 7 | |
| other | Neutropenia | Blood and lymphatic system disorders | Pralatrexate Arm | 1 | 14 | |
| other | Neutropenia | Blood and lymphatic system disorders | Observation Arm | 1 | 7 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pralatrexate Arm | 2 | 14 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Observation Arm | 0 | 7 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Pralatrexate Arm | 1 | 14 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Observation Arm | 0 | 7 | |
| other | Abdominal Pain | Gastrointestinal disorders | Pralatrexate Arm | 3 | 14 | |
| other | Abdominal Pain | Gastrointestinal disorders | Observation Arm | 1 | 7 |
1 to 10 of 290Source ClinicalTrials.gov
See all 290 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pralatrexate Arm | 3 | 14 |
| Total, all-cause mortality | Observation Arm | 1 | 7 |
| Total, other adverse events | Pralatrexate Arm | 14 | 14 |
| Total, other adverse events | Observation Arm | 6 | 7 |
| Total, serious adverse events | Pralatrexate Arm | 4 | 14 |
| Total, serious adverse events | Observation Arm | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pralatrexate Arm vs Observation Arm: deaths from any cause | Trial comparisons |
| Pralatrexate Arm vs Observation Arm: serious adverse events | Trial comparisons |
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.
GET https://conductscience.org/api/trials/v1/NCT01420679
GET https://conductscience.org/api/trials/v1/NCT01420679/events?page=2