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

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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

All patients who completed at least 1 cycle of treatment were included in the efficacy analysis

→

secondary · POSTED

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)

Source null

→

secondary · POSTED

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 null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-truxima-09fad21d
nct id: NCT00481871
trial label: Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies
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: 3
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00481871
outcome key
om-0000
source section id
NCT00481871-om-0000
source outcome index
0
endpoint
Objective Responses Assessed by International Workshop Criteria (IWC)
endpoint definition
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.
time origin
Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patients who completed at least 1 cycle of treatment were included in the efficacy analysis
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-truxima-09fad21d
nct id
NCT00481871
outcome key
om-0001
source section id
NCT00481871-om-0001
source outcome index
1
endpoint
Duration of Response
endpoint definition
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)
time origin
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
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-truxima-09fad21d
nct id
NCT00481871
outcome key
om-0002
source section id
NCT00481871-om-0002
source outcome index
2
endpoint
Progression-free Survival (PFS) Time
endpoint definition
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).
time origin
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
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-truxima-09fad21d
nct id
NCT00481871
outcome key
om-0000
arm key
OG000
arm label
Phase 1
regimen
Includes the Phase 1 dose-finding groups A, B, and C
analyzed count
34
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00481871-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00481871
outcome key
om-0000
arm key
OG001
arm label
Phase 2 - Group B
regimen
Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
analyzed count
38
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00481871-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00481871
outcome key
om-0000
arm key
OG002
arm label
Phase 2 - Group C
regimen
Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
analyzed count
34
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00481871-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00481871
outcome key
om-0001
arm key
OG000
arm label
Phase 1
regimen
Includes the Phase 1 dose-finding groups A, B, and C
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00481871-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00481871
outcome key
om-0001
arm key
OG001
arm label
Phase 2 - Group B
regimen
Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00481871-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00481871
outcome key
om-0001
arm key
OG002
arm label
Phase 2 - Group C
regimen
Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00481871-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00481871
outcome key
om-0002
arm key
OG000
arm label
Phase 1
regimen
Includes the Phase 1 dose-finding groups A, B, and C
analyzed count
34
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00481871-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00481871
outcome key
om-0002
arm key
OG001
arm label
Phase 2 - Group B
regimen
Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
analyzed count
38
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00481871-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00481871
outcome key
om-0002
arm key
OG002
arm label
Phase 2 - Group C
regimen
Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
analyzed count
34
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00481871-om-0002#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00481871
harm key
EG000
source section id
NCT00481871-ae
event group key
EG000
event group label
Phase 1
serious affected
18
serious at risk
35
other affected
35
other at risk
35
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
Source null
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-truxima-09fad21d
nct id
NCT00481871
harm key
EG001
source section id
NCT00481871-ae
event group key
EG001
event group label
Phase 2 - Group B
serious affected
13
serious at risk
38
other affected
38
other at risk
38
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
Source null
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-truxima-09fad21d
nct id
NCT00481871
harm key
EG002
source section id
NCT00481871-ae
event group key
EG002
event group label
Phase 2 - Group C
serious affected
16
serious at risk
34
other affected
34
other at risk
34
frequency threshold
5
collection period
Source null
event definition
Source null
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