TriangleNCT00711828 · STUDY IN CONTEXT
Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle
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
A response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on any evaluation (i.e., best response). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A confidence interval for the true success proportion will be calculated according to the properties of the binomial distribution.
Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression or death, whichever occurs first. Progression is defines as having any new lesion or increase by 50% of previously involved sites from nadir. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented. MR for Waldenstrom lymphoma will not be included as a response. Median duration of response and the confidence interval for the median duration will be computed.
Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.
Adverse events were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report.
Reported safety
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-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- trial label
- Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle
- 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
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- outcome key
- om-0000
- source section id
- NCT00711828-om-0000
- source outcome index
- 0
- endpoint
- Proportion of Responses (Complete Response or Partial Response)
- endpoint definition
- A response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on any evaluation (i.e., best response). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A confidence interval for the true success proportion will be calculated according to the properties of the binomial distribution.
- time origin
- up to 12 cycles
- 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-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- outcome key
- om-0001
- source section id
- NCT00711828-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival
- endpoint definition
- Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
- time origin
- Up to 3 years from registration
- 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-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- outcome key
- om-0002
- source section id
- NCT00711828-om-0002
- source outcome index
- 2
- endpoint
- Progression-free Survival
- endpoint definition
- Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression or death, whichever occurs first. Progression is defines as having any new lesion or increase by 50% of previously involved sites from nadir. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.
- time origin
- Up to 3 years from registration
- 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-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- outcome key
- om-0003
- source section id
- NCT00711828-om-0003
- source outcome index
- 3
- endpoint
- Duration of Response
- endpoint definition
- Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented. MR for Waldenstrom lymphoma will not be included as a response. Median duration of response and the confidence interval for the median duration will be computed.
- time origin
- Up to 3 years from registration
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Thirteen patients achieved a CR or a PR and are included in this 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-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- outcome key
- om-0004
- source section id
- NCT00711828-om-0004
- source outcome index
- 4
- endpoint
- Time to Treatment Failure
- endpoint definition
- Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.
- time origin
- Up to 3 years from registration
- 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-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- outcome key
- om-0005
- source section id
- NCT00711828-om-0005
- source outcome index
- 5
- endpoint
- Adverse Events
- endpoint definition
- Adverse events were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report.
- time origin
- up to 12 cycles (28 days per cycle) of 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment
- regimen
- Rituximab 375 mg/m2 IV on day 1 \> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 \> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 \> Dexamethasone 40 mg PO on days 1, 8, 15, 22
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00711828-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment
- regimen
- Rituximab 375 mg/m2 IV on day 1 \> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 \> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 \> Dexamethasone 40 mg PO on days 1, 8, 15, 22
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00711828-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment
- regimen
- Rituximab 375 mg/m2 IV on day 1 \> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 \> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 \> Dexamethasone 40 mg PO on days 1, 8, 15, 22
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00711828-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment
- regimen
- Rituximab 375 mg/m2 IV on day 1 \> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 \> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 \> Dexamethasone 40 mg PO on days 1, 8, 15, 22
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00711828-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment
- regimen
- Rituximab 375 mg/m2 IV on day 1 \> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 \> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 \> Dexamethasone 40 mg PO on days 1, 8, 15, 22
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00711828-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment
- regimen
- Rituximab 375 mg/m2 IV on day 1 \> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 \> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 \> Dexamethasone 40 mg PO on days 1, 8, 15, 22
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00711828-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
- nct id
- NCT00711828
- harm key
- EG000
- source section id
- NCT00711828-ae
- event group key
- EG000
- event group label
- Treatment
- serious affected
- 7
- serious at risk
- 21
- other affected
- 21
- other at risk
- 21
- 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