Trial · NCT00481871

Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies

NCT00481871, Phase 1, Phase 2, Completed, Acrotech Biopharma Inc.; results first posted 2012-09-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies. Trials, record NCT00481871. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00481871

On this page

Trial

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

Title: Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies
NCT number: NCT00481871
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 119 participants, actual
Lead sponsor: Acrotech Biopharma Inc.
Conditions: Relapsed or Refractory Lymphoproliferative Malignancies, Hodgkin's Lymphoma, Peripheral T-cell Lymphoma, B-cell Lymphoma, Waldenstrom's Macroglobulinemia
Interventions: Pralatrexate Injection, Gemcitabine Hydrochloride, Vitamin B12, Folic Acid
First posted: 2007-06-04
Last updated: 2020-01-07
Results first posted: 2012-09-18

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Objective Responses Assessed by International Workshop Criteria (IWC)	Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I	Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.
Secondary	Duration of Response	Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study	Duration of response was defined as the number of days between the date of first tumor response assessment of objective response to the time of the first tumor response assessment of progressive disease (PD) or death due to any cause (date of first PD assessment or death - date of first objective response assessment + 1)
Secondary	Progression-free Survival (PFS) Time	Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study	PFS time was calculated as the number of days from study day 1 to the date of PD or death, regardless of cause (date of PD or death - study day 1 + 1).

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Responses Assessed by International Workshop Criteria (IWC)	Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I	All patients who completed at least 1 cycle of treatment were included in the efficacy analysis	participants	NUMBER
SECONDARY	Duration of Response	Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study		days	MEDIAN
SECONDARY	Progression-free Survival (PFS) Time	Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study		days	MEDIAN

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Spread	Units
Objective Responses Assessed by International Workshop Criteria (IWC)	Phase 1	8		participants
Objective Responses Assessed by International Workshop Criteria (IWC)	Phase 2 - Group B	5		participants
Objective Responses Assessed by International Workshop Criteria (IWC)	Phase 2 - Group C	7		participants
Duration of Response	Phase 1	174	Full Range 35 to 288	days
Duration of Response	Phase 2 - Group B	210	Full Range 57 to 210	days
Duration of Response	Phase 2 - Group C	170	Full Range 59 to 178	days
Progression-free Survival (PFS) Time	Phase 1	53.0	95% Confidence Interval 49.0 to 106.0	days
Progression-free Survival (PFS) Time	Phase 2 - Group B	59.0	95% Confidence Interval 52.0 to 99.0	days
Progression-free Survival (PFS) Time	Phase 2 - Group C	54.0	95% Confidence Interval 45.0 to 89.0	days

Source ClinicalTrials.gov

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase 1 Group A - Dose Finding	7
Overall Study	STARTED	Phase 1 Group B - Dose Finding	10
Overall Study	STARTED	Phase 1 Group C - Dose Finding	18
Overall Study	STARTED	Phase 2 Group B	38
Overall Study	STARTED	Phase 2 Group C	34
Overall Study	COMPLETED	Phase 1 Group A - Dose Finding	7
Overall Study	COMPLETED	Phase 1 Group B - Dose Finding	10
Overall Study	COMPLETED	Phase 1 Group C - Dose Finding	17
Overall Study	COMPLETED	Phase 2 Group B	38
Overall Study	COMPLETED	Phase 2 Group C	34

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events573

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	fatigue	General disorders	Phase 1	25	35
other	fatigue	General disorders	Phase 2 - Group B	18	38
other	fatigue	General disorders	Phase 2 - Group C	15	34
other	pyrexia	General disorders	Phase 1	23	35
other	pyrexia	General disorders	Phase 2 - Group B	18	38
other	pyrexia	General disorders	Phase 2 - Group C	15	34
other	chills	General disorders	Phase 1	6	35
other	chills	General disorders	Phase 2 - Group B	12	38
other	chills	General disorders	Phase 2 - Group C	4	34
other	oedema peripheral	General disorders	Phase 1	5	35

1 to 10 of 573Source ClinicalTrials.gov

See all 573 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 1
Total, all-cause mortality	Phase 2 - Group B
Total, all-cause mortality	Phase 2 - Group C
Total, other adverse events	Phase 1	35	35
Total, other adverse events	Phase 2 - Group B	38	38
Total, other adverse events	Phase 2 - Group C	34	34
Total, serious adverse events	Phase 1	18	35
Total, serious adverse events	Phase 2 - Group B	13	38
Total, serious adverse events	Phase 2 - Group C	16	34

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/NCT00481871

GET https://conductscience.org/api/trials/v1/NCT00481871/events?page=2

API reference For AI assistants