NCT00142116 · STUDY IN CONTEXT

Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

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

Response determinations were made using modified consensus panel criteria from the Third International Workshop on WM, and response rates were determined on an evaluable basis. A complete response was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. Patients achieving a partial response and a minor response were defined as achieving a more than or equal to 50% and more than or equal to 25% reduction in serum IgM levels, respectively. Patients with stable disease were defined as having less than 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM. Progressive disease was defined as a greater than 25% increase in serum IgM level occurred from the lowest attained response value or progression of clinically significant disease-related symptom(s).

Intent-to-treat basis

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primary · POSTED

Time to disease progression (TTP) was calculated from the start of therapy using the Kaplan-Meier method.

Source null

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secondary · NOT_POSTED

To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity.

Source null

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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-indolent-b-cell-non-hodgkin-lymphoma
nct id: NCT00142116
trial label: Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia
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: 3
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142116
outcome key
om-0000
source section id
NCT00142116-om-0000
source outcome index
0
endpoint
Objective Response Rate
endpoint definition
Response determinations were made using modified consensus panel criteria from the Third International Workshop on WM, and response rates were determined on an evaluable basis. A complete response was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. Patients achieving a partial response and a minor response were defined as achieving a more than or equal to 50% and more than or equal to 25% reduction in serum IgM levels, respectively. Patients with stable disease were defined as having less than 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM. Progressive disease was defined as a greater than 25% increase in serum IgM level occurred from the lowest attained response value or progression of clinically significant disease-related symptom(s).
time origin
3 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-treat basis
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-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142116
outcome key
om-0002
source section id
NCT00142116-om-0002
source outcome index
2
endpoint
Time to Progression
endpoint definition
Time to disease progression (TTP) was calculated from the start of therapy using the Kaplan-Meier method.
time origin
49.1 months
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-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142116
outcome key
om-0001
source section id
NCT00142116-om-0001
source outcome index
1
endpoint
To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity.
endpoint definition
To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity.
time origin
3 years
analysis role
secondary
reporting status
NOT_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-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142116
outcome key
om-0000
arm key
OG000
arm label
All WM Patients
regimen
Waldenstrom's Macroglobulinemia Patients
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00142116-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142116
outcome key
om-0002
arm key
OG000
arm label
Thalidomide and Rituximab
regimen
Thalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later. Thalidomide: 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks. Rituximab: Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00142116-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142116
harm key
EG000
source section id
NCT00142116-ae
event group key
EG000
event group label
All WM Patients
serious affected
2
serious at risk
25
other affected
19
other at risk
25
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