Trial · NCT00364923

Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

NCT00364923, Phase 2, Completed, Acrotech Biopharma Inc.; results first posted 2010-02-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma. Trials, record NCT00364923. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00364923

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
NCT number: NCT00364923
Status: Completed
Phases: Phase 2
Enrollment: 115 participants, actual
Lead sponsor: Acrotech Biopharma Inc.
Conditions: Peripheral T-cell Lymphoma
Interventions: Pralatrexate Injection
First posted: 2006-08-16
Last updated: 2019-12-19
Other registries' IDs: eudract:2006-002811-29
Results first posted: 2010-02-01
Limitations and caveats: Outcome Measure (primary and secondary), Serious Adverse Event and Adverse Event data presented have a cut-off date of August 2009.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Response Rate Per Independent Central Review	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	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.
Secondary	Duration of Response Per Independent Central Review	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	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.
Secondary	Progression-free Survival Per Independent Central Review	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	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.
Secondary	Overall Survival Per Independent Central Review	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.	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.

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	Response Rate Per Independent Central Review	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 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.	of Patients who Responded	NUMBER
SECONDARY	Duration of Response Per Independent Central Review	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 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.	Days	MEDIAN
SECONDARY	Progression-free Survival Per Independent Central Review	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 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.	Days	MEDIAN
SECONDARY	Overall Survival Per Independent Central Review	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 was per protocol, based on the number of patients (pts) who had an event (death or censoring) at the time of data cut-off.	Months	MEDIAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Response Rate Per Independent Central Review	Evaluable Population	32		of Patients who Responded
Duration of Response Per Independent Central Review	Evaluable Population	306	Full Range 1 to 673	Days
Progression-free Survival Per Independent Central Review	Evaluable Population	106	Full Range 1 to 726	Days
Overall Survival Per Independent Central Review	Evaluable Population	14.5	Full Range 1 to 24.1	Months

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment With Pralatrexate	STARTED	Full Population	111
Treatment With Pralatrexate	COMPLETED	Full Population	107
Treatment With Pralatrexate	NOT COMPLETED	Full Population	4
Survival Follow-up, After Pralatrexate	STARTED	Full Population	107
Survival Follow-up, After Pralatrexate	COMPLETED	Full Population	83
Survival Follow-up, After Pralatrexate	NOT COMPLETED	Full Population	24

Source ClinicalTrials.gov

Adverse events114

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
other	stomatitis	Gastrointestinal disorders	Full Population	76	111
other	nausea	Gastrointestinal disorders	Full Population	45	111
other	constipation	Gastrointestinal disorders	Full Population	38	111
other	vomiting	Gastrointestinal disorders	Full Population	28	111
other	diarrhea	Gastrointestinal disorders	Full Population	25	111
other	abdominal pain	Gastrointestinal disorders	Full Population	12	111
other	abdominal pain upper	Gastrointestinal disorders	Full Population	9	111
other	gastroesophageal reflux disease	Gastrointestinal disorders	Full Population	7	111
other	flatulence	Gastrointestinal disorders	Full Population	6	111
other	hemorrhoids	Gastrointestinal disorders	Full Population	6	111

1 to 10 of 114Source ClinicalTrials.gov

See all 114 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Full Population
Total, other adverse events	Full Population	111	111
Total, serious adverse events	Full Population	50	111

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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00364923

GET https://conductscience.org/api/trials/v1/NCT00364923/events?page=2

API reference For AI assistants