Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory 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 · POSTED

Participants will be treated in cohorts of 6 patients at each dose level of CpG 7909 (0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg) and observed for at least 10 weeks post treatment. If at most one of the 6 patients experiences a dose limiting toxicity (DLT), a new cohort of 6 patients will be treated at the next higher dose level. A DLT for this study is defined as patients with one of the following: * Absolute neutrophil counts or platelet counts below 10\10\^9/L for 14 days Absolute neutrophil counts greater than 0.5 or less than 1\10\^9/L Platelet counts greater than 10 or less than 50\10\^9/L for 28 days. Any grade 3 non-hematologic toxicity not explainable by another obvious cause as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. We are reporting the number of DLTs at each of the dose levels. The maximum tolerated dose will be 0.48 mg/kg or the largest dose level where 1 or fewer participants reports a dose limiting toxicity.

Only participants accrued to the Phase I portion of this study were used to determine the maximum tolerated dose.

→

primary · POSTED

Complete Response (CR): * No measurable or nonmeasurable disease. * No symptoms of Lymphoma. * Non-palpable spleen, if palpable at baseline. * Histologically negative bone marrow, if positive at baseline. * All nodes \<1.5 cm in transverse diameter. Partial Response (PR): * greater than 50% decrease from baseline in the sum of the products of the longest perpendicular diameters of the six largest dominant lesions. * No new lesions We are reporting the number of participants that attained a status of CR or PR.

Participants accrued to the Phase I portion of this study were not used to analyze the Phase II primary endpoint.

→

secondary · POSTED

The Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.

Only participants accrued to the Phase II portion of the study were evaluated for this endpoint.

→

secondary · POSTED

Duration of response (DoR) will be calculated from the documentation of response until the date of progression in the subset of patients who respond.

The duration of response was not analyzed due to a lack of more than one response.

→

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-ruxience-816f4f4a
nct id: NCT00438880
trial label: Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory 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: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-ruxience-816f4f4a
nct id
NCT00438880
outcome key
om-0000
source section id
NCT00438880-om-0000
source outcome index
0
endpoint
Maximum Tolerated Dose of CpG 7909 as Determined Using the Number of Participants With a DLT at Each Dose Level
endpoint definition
Participants will be treated in cohorts of 6 patients at each dose level of CpG 7909 (0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg) and observed for at least 10 weeks post treatment. If at most one of the 6 patients experiences a dose limiting toxicity (DLT), a new cohort of 6 patients will be treated at the next higher dose level. A DLT for this study is defined as patients with one of the following: * Absolute neutrophil counts or platelet counts below 10\*10\^9/L for 14 days * Absolute neutrophil counts greater than 0.5 or less than 1\*10\^9/L * Platelet counts greater than 10 or less than 50\*10\^9/L for 28 days. * Any grade 3 non-hematologic toxicity not explainable by another obvious cause as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. We are reporting the number of DLTs at each of the dose levels. The maximum tolerated dose will be 0.48 mg/kg or the largest dose level where 1 or fewer participants reports a dose limiting toxicity.
time origin
at least 10 weeks post treatment up to 3 months.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Only participants accrued to the Phase I portion of this study were used to determine the maximum tolerated dose.
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-ruxience-816f4f4a
nct id
NCT00438880
outcome key
om-0001
source section id
NCT00438880-om-0001
source outcome index
1
endpoint
Tumor Response
endpoint definition
Complete Response (CR): * No measurable or nonmeasurable disease. * No symptoms of Lymphoma. * Non-palpable spleen, if palpable at baseline. * Histologically negative bone marrow, if positive at baseline. * All nodes \<1.5 cm in transverse diameter. Partial Response (PR): * greater than 50% decrease from baseline in the sum of the products of the longest perpendicular diameters of the six largest dominant lesions. * No new lesions We are reporting the number of participants that attained a status of CR or PR.
time origin
Evaluations occur every three months up to a year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants accrued to the Phase I portion of this study were not used to analyze the Phase II primary endpoint.
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-ruxience-816f4f4a
nct id
NCT00438880
outcome key
om-0002
source section id
NCT00438880-om-0002
source outcome index
2
endpoint
Progression-free Survival
endpoint definition
The Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.
time origin
Up to 1 year from treatment start date
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Only participants accrued to the Phase II portion of the study were evaluated for this endpoint.
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-ruxience-816f4f4a
nct id
NCT00438880
outcome key
om-0003
source section id
NCT00438880-om-0003
source outcome index
3
endpoint
Duration of Response
endpoint definition
Duration of response (DoR) will be calculated from the documentation of response until the date of progression in the subset of patients who respond.
time origin
Up to 1 year from treatment start date
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The duration of response was not analyzed due to a lack of more than one response.
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-ruxience-816f4f4a
nct id
NCT00438880
outcome key
om-0000
arm key
OG000
arm label
Phase I
regimen
Phase I patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1 * 10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00438880-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-ruxience-816f4f4a
nct id
NCT00438880
outcome key
om-0000
arm key
OG001
arm label
Phase II
regimen
Phase II patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * 0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00438880-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-ruxience-816f4f4a
nct id
NCT00438880
outcome key
om-0001
arm key
OG000
arm label
Phase I
regimen
Phase I patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1 * 10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00438880-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-ruxience-816f4f4a
nct id
NCT00438880
outcome key
om-0001
arm key
OG001
arm label
Phase II
regimen
Phase II patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * 0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00438880-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-ruxience-816f4f4a
nct id
NCT00438880
outcome key
om-0002
arm key
OG000
arm label
Phase I
regimen
Phase I patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1 * 10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00438880-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-ruxience-816f4f4a
nct id
NCT00438880
outcome key
om-0002
arm key
OG001
arm label
Phase II
regimen
Phase II patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * 0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00438880-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-ruxience-816f4f4a
nct id
NCT00438880
outcome key
om-0003
arm key
OG000
arm label
Phase I
regimen
Phase I patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1 * 10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00438880-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-ruxience-816f4f4a
nct id
NCT00438880
outcome key
om-0003
arm key
OG001
arm label
Phase II
regimen
Phase II patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * 0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00438880-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-ruxience-816f4f4a
nct id
NCT00438880
harm key
EG000
source section id
NCT00438880-ae
event group key
EG000
event group label
Phase I
serious affected
14
serious at risk
30
other affected
30
other at risk
30
frequency threshold
0
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-ruxience-816f4f4a
nct id
NCT00438880
harm key
EG001
source section id
NCT00438880-ae
event group key
EG001
event group label
Phase II
serious affected
5
serious at risk
8
other affected
8
other at risk
8
frequency threshold
0
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