Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma

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 · NOT_STATED

A group of 3 patients would start treatment ast the dose of 900mg/m\^2 BID, and if none of the 3 experienced a DLT, another 3 would then be treated at that dose. Dose Limiting Toxicity was defined as any related toxicity of grade 4 or 5 on or before the completion of 4 weeks of therapy. Per response evaluation criteria 1999 Cheson Response Criteria for Malignant Lymphoma (CHESON99) for target lesions assessed by either CT or MRI: Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; Complete Response Unconfirmed (CRU): Complete disappearance of all measurable and non-measurable disease, with the exception of all residual nodal masses \>1.5cm in Greatest Transverse Diameter (GTD) reduced by 75% in Sum of the Product of the greatest Diameters (SPD); Partial Response (PR): 50% decrease in the SPD.

7 participants were analyzed in the Rituximab Naive arm and 16 participants were analyzed in the Rituximab Pre Treated Arm.

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primary · NOT_STATED

The trial was stratified into rituximab-naïve and rituximab pre-treated patients, and the target response rates for these groups were expected to be 30% and 10%, respectively. The numbers reported below are subjects who achieved a response of partial response or better.

No subjects in Phase 1 met the DLT, therefore Phase II was conducted at 900mg/m2. Of the 32 subjects, 4 subjects were not evaluable for disease response (2 subjects in Phase 1 and 2 subjects in Phase 2).

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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: NCT00288067
trial label: Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
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: 2
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00288067
outcome key
om-0000
source section id
NCT00288067-om-0000
source outcome index
0
endpoint
Safety, in Terms of Dose-limiting Toxicity (DLT) of 2 Daily Doses of Single Agent Fenretinide (Phase I)
endpoint definition
A group of 3 patients would start treatment ast the dose of 900mg/m\^2 BID, and if none of the 3 experienced a DLT, another 3 would then be treated at that dose. Dose Limiting Toxicity was defined as any related toxicity of grade 4 or 5 on or before the completion of 4 weeks of therapy. Per response evaluation criteria 1999 Cheson Response Criteria for Malignant Lymphoma (CHESON99) for target lesions assessed by either CT or MRI: Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; Complete Response Unconfirmed (CRU): Complete disappearance of all measurable and non-measurable disease, with the exception of all residual nodal masses \>1.5cm in Greatest Transverse Diameter (GTD) reduced by 75% in Sum of the Product of the greatest Diameters (SPD); Partial Response (PR): 50% decrease in the SPD.
time origin
Number of participants that experienced a dose-limiting toxicity
analysis role
primary
reporting status
NOT_STATED
data cutoff
Source null
population note
7 participants were analyzed in the Rituximab Naive arm and 16 participants were analyzed in the Rituximab Pre Treated Arm.
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
NCT00288067
outcome key
om-0001
source section id
NCT00288067-om-0001
source outcome index
1
endpoint
Response Rates of B-Non-Hodgkin Lymphoma to the Combination of Rituximab and Fenretinide (Phase II)
endpoint definition
The trial was stratified into rituximab-naïve and rituximab pre-treated patients, and the target response rates for these groups were expected to be 30% and 10%, respectively. The numbers reported below are subjects who achieved a response of partial response or better.
time origin
Up to 7 years
analysis role
primary
reporting status
NOT_STATED
data cutoff
Source null
population note
No subjects in Phase 1 met the DLT, therefore Phase II was conducted at 900mg/m2. Of the 32 subjects, 4 subjects were not evaluable for disease response (2 subjects in Phase 1 and 2 subjects in Phase 2).
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
NCT00288067
outcome key
om-0000
arm key
OG000
arm label
Fenretinide and Rituximab
regimen
PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity. pharmacological study : Correlative studies rituximab : Given IV fenretinide : Given PO
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00288067-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00288067
outcome key
om-0001
arm key
OG000
arm label
Fenretinide and Rituximab (Rituximab Naive)
regimen
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00288067-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00288067
outcome key
om-0001
arm key
OG001
arm label
Fenretinide and Rituximab (Rituximab Pre Treated)
regimen
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00288067-om-0001#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-truxima-09fad21d
nct id
NCT00288067
harm key
EG000
source section id
NCT00288067-ae
event group key
EG000
event group label
Fenretinide and Rituximab
serious affected
6
serious at risk
32
other affected
32
other at risk
32
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