Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Count of participants that received the investigational therapy without incurring the protocol suspension rules. A stopping rule for safety was employed such that the study would be suspended if sufficient evidence indicated that the true grade 4-5 non-hematologic toxicity rate exceeded 10%.

Source null

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secondary · POSTED

Response was assessed per standard criteria (Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria fornon-Hodgkin's lymphomas. J Clin Oncol 1999;17:1244-1253.)

Source null

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secondary · POSTED

Count of participants with grade 3/4 hematologic and non-hematologic adverse events.

Source null

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secondary · POSTED

Count of patients that attempted and had successful autologous peripheral blood stem cell (PBSC) collection.

Successful PBSC collection is only considered in those patients that attempted PBSC collection.

→

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-aggressive-b-cell-non-hodgkin-lymphoma
nct id: NCT00072514
trial label: Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
nct id
NCT00072514
outcome key
om-0000
source section id
NCT00072514-om-0000
source outcome index
0
endpoint
Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules
endpoint definition
Count of participants that received the investigational therapy without incurring the protocol suspension rules. A stopping rule for safety was employed such that the study would be suspended if sufficient evidence indicated that the true grade 4-5 non-hematologic toxicity rate exceeded 10%.
time origin
At 3-4 weeks after completion of study treatment
analysis role
primary
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-aggressive-b-cell-non-hodgkin-lymphoma
nct id
NCT00072514
outcome key
om-0001
source section id
NCT00072514-om-0001
source outcome index
1
endpoint
Overall and Complete Response Rates
endpoint definition
Response was assessed per standard criteria (Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria fornon-Hodgkin's lymphomas. J Clin Oncol 1999;17:1244-1253.)
time origin
3-4 weeks after completion of study treatment
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-aggressive-b-cell-non-hodgkin-lymphoma
nct id
NCT00072514
outcome key
om-0002
source section id
NCT00072514-om-0002
source outcome index
2
endpoint
Hematologic and Non-hematologic Adverse Events.
endpoint definition
Count of participants with grade 3/4 hematologic and non-hematologic adverse events.
time origin
3-4 weeks after completion of study treatment
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-aggressive-b-cell-non-hodgkin-lymphoma
nct id
NCT00072514
outcome key
om-0003
source section id
NCT00072514-om-0003
source outcome index
3
endpoint
Peripheral Blood Stem Cell Collection
endpoint definition
Count of patients that attempted and had successful autologous peripheral blood stem cell (PBSC) collection.
time origin
Up to 12 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Successful PBSC collection is only considered in those patients that attempted PBSC collection.
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-aggressive-b-cell-non-hodgkin-lymphoma
nct id
NCT00072514
outcome key
om-0000
arm key
OG000
arm label
Treatment
regimen
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
analyzed count
51
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00072514-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
nct id
NCT00072514
outcome key
om-0001
arm key
OG000
arm label
Treatment
regimen
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
analyzed count
51
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00072514-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
nct id
NCT00072514
outcome key
om-0002
arm key
OG000
arm label
Treatment
regimen
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
analyzed count
51
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00072514-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
nct id
NCT00072514
outcome key
om-0003
arm key
OG000
arm label
Treatment
regimen
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
analyzed count
51
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00072514-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-aggressive-b-cell-non-hodgkin-lymphoma
nct id
NCT00072514
harm key
EG000
source section id
NCT00072514-ae
event group key
EG000
event group label
Treatment
serious affected
0
serious at risk
51
other affected
45
other at risk
51
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