Trial · NCT01381692
Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma
NCT01381692, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2021-05-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma. Trials, record NCT01381692. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01381692
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma
- NCT number
- NCT01381692
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Small Lymphocytic Lymphoma, Recurrent Waldenstrom Macroglobulinemia, Refractory Follicular Lymphoma, Refractory Mantle Cell Lymphoma, Refractory Marginal Zone Lymphoma, Refractory Non-Hodgkin Lymphoma, Refractory Small Lymphocytic Lymphoma
- Interventions
- Bortezomib, Dexamethasone, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Rituximab, Temsirolimus
- First posted
- 2011-06-27
- Last updated
- 2021-10-04
- Results first posted
- 2021-05-05
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: The Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Bortezomib, Rituximab and Dexamethasone | Assessed during cycle 1 (28 days) | Temsirolimus in combination with bortezomib, rituximab, dexamethasone were to be escalated using a standard 3+3 design. The MTD was defined as the highest dose level at which no more than 0 in 3 or 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment. |
| Primary | Phase II: Progression-free Survival | Assessed every 3 months if <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 years | Progression-free survival is defined as the time from randomization to progression or death, whichever occurred first. Progression is evaluated based on Recommended Response Criteria for Waldenstrom's Macroglobulinemia. Progression is defined as at least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed by a second measurement at any time, as well as an absolute increase of the M-spike by 0.5g/dL, or progression of clinically significant findings due to disease, (i.e. anemia, thrombocytopenia, leukopenia, bulky adenopathy/organomegaly or symptoms of disease) or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis attributable to WM. |
| Secondary | Phase II: Time to Progression | Assessed every 3 months if <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 years | Time to progression is defined as the time from randomization to disease progression. Progression is evaluated based on Recommended Response Criteria for Waldenstrom's Macroglobulinemia. Progression is defined as at least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed by a second measurement at any time, as well as an absolute increase of the M-spike by 0.5g/dL, or progression of clinically significant findings due to disease, (i.e. anemia, thrombocytopenia, leukopenia, bulky adenopathy/organomegaly or symptoms of disease) or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis attributable to WM. |
| Secondary | Phase II: Major Response Rate | Assessed at cycle 6 | Response is evaluated based on Recommended Response Criteria for Waldenstrom's Macroglobulinemia (WM). Major response is defined as complete response (CR), near CR (nCR), very good partial remission (VGPR), or partial response (PR). CR: Disappearance of monoclonal protein by immmunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly, or signs or symptoms attributable to WM Near CR (nCR): As for CR except that immunofixation is still positive VGPR: At least 90% reduction of serum monoclonal protein using serum protein electrophoresis (SPEP) PR: At least 50% reduction of serum monoclonal concentration on protein electrophoresis and at least a decrease in adenopathy/organomegaly (confirmed by original mode of imaging). No new signs or symptoms of active disease. |
| Secondary | Phase II: Minor Response Rate | Assessed at cycle 6 | Response is evaluated based on Recommended Response Criteria for Waldenstrom's Macroglobulinemia (WM). Minor response is defined as achieving minor response (MR) or better (including complete response \[CR\], near CR (nCR), very good partial remission \[VGPR\], partial response \[PR\] and MR). CR: Disappearance of monoclonal protein by immmunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly, or signs or symptoms attributable to WM nCR: As CR except that immunofixation is still positive VGPR: At least 90% reduction of serum monoclonal protein using serum protein electrophoresis PR: At least 50% reduction of serum monoclonal concentration on protein electrophoresis and at least a decrease in adenopathy/organomegaly (confirmed by original mode of imaging). No new signs or symptoms of active disease. MR: At least 25% but less than 50% reduction of serum monoclonal protein and no new signs or symptoms of active disease. |
| Secondary | Phase II: Time to Response | Assessed every 3 months if <2 years of study entry, every 6 months if 2-5 years of study entry, and annually if 6-10 years | Time to response is defined as the time from randomization to documentation of response. Response is evaluated based on Recommended Response Criteria for Waldenstrom's Macroglobulinemia (WM). Response is defined as complete response (CR), near CR (nCR), very good partial remission (VGPR), partial response (PR) or minor response (MR). CR: Disappearance of monoclonal protein by immmunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly, or signs or symptoms attributable to WM nCR: As CR except that immunofixation is still positive VGPR: \>=90% reduction of serum monoclonal protein using serum protein electrophoresis PR: \>=50% reduction of serum monoclonal concentration on protein electrophoresis and at least a decrease in adenopathy/organomegaly (confirmed by original mode of imaging). No new signs or symptoms of active disease. MR: \>=25% but \<50% reduction of serum monoclonal protein. No new signs or symptoms of active disease |
| Secondary | Phase II: Duration of Response | Assessed every 3 months if <2 years of study entry, every 6 months if 2-5 years of study entry, and annually if 6-10 years | Duration of response is defined as the time from documentation of response to disease progression. Response evaluation will be based on the Recommended Response Criteria for Waldenstrom's Macroglobulinemia (WM). Response is defined as complete response (CR), near CR (nCR), very good partial remission (VGPR), partial response (PR) or minor response (MR). Progression is defined as at least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed by a second measurement at any time, as well as an absolute increase of the M-spike by 0.5g/dL, or progression of clinically significant findings due to disease, or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis attributable to WM. |
| Secondary | Phase II: Time to Next Therapy | Assessed every 3 months if <2 years of study entry, every 6 months if 2-5 years of study entry, and annually if 6-10 years | Time to next therapy is defined as duration from the end of protocol treatment to the initiation of next therapy, censored at date last known alive without initiation of next therapy. |
| Secondary | Phase II: Overall Survival | Assessed every 3 months if <2 years of study entry, every 6 months if 2-5 years of study entry, and annually if 6-10 years | Overall survival is defined as the time from randomization to date of death or date last known alive. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I: The Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Bortezomib, Rituximab and Dexamethasone | Assessed during cycle 1 (28 days) | mg | NUMBER | |
| PRIMARY | Phase II: Progression-free Survival | Assessed every 3 months if <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 years | No patients were enrolled in the phase II part of this study. | ||
| SECONDARY | Phase II: Time to Progression | Assessed every 3 months if <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 years | No patients were enrolled in the phase II part of this study. | ||
| SECONDARY | Phase II: Major Response Rate | Assessed at cycle 6 | No patients were enrolled in the phase II part of this study. | ||
| SECONDARY | Phase II: Minor Response Rate | Assessed at cycle 6 | No patients were enrolled in the phase II part of this study. | ||
| SECONDARY | Phase II: Time to Response | Assessed every 3 months if <2 years of study entry, every 6 months if 2-5 years of study entry, and annually if 6-10 years | No patients were enrolled in the phase II part of this study. | ||
| SECONDARY | Phase II: Duration of Response | Assessed every 3 months if <2 years of study entry, every 6 months if 2-5 years of study entry, and annually if 6-10 years | No patients were enrolled in the phase II part of this study. | ||
| SECONDARY | Phase II: Time to Next Therapy | Assessed every 3 months if <2 years of study entry, every 6 months if 2-5 years of study entry, and annually if 6-10 years | No patients were enrolled in the phase II part of this study. | ||
| SECONDARY | Phase II: Overall Survival | Assessed every 3 months if <2 years of study entry, every 6 months if 2-5 years of study entry, and annually if 6-10 years | No patients were enrolled in the phase II part of this study. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I: The Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Bortezomib, Rituximab and Dexamethasone | Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) | NA | mg | ||
| Phase I: The Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Bortezomib, Rituximab and Dexamethasone | Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | NA | mg |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) | 7 | |
| Overall Study | STARTED | Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | 2 | |
| Overall Study | STARTED | Arm C (Phase I: Temsirolimus Dose Level 3, Rituximab, Bortezomib, Dexamethasone) | 0 | |
| Overall Study | STARTED | Arm D (Phase I: Temsirolimus Dose Level 4, Rituximab, Bortezomib, Dexamethasone) | 0 | |
| Overall Study | STARTED | Arm E (Phase II: Rituximab, Bortezomib, Dexamethasone) | 0 | |
| Overall Study | STARTED | Arm F (Phase II: Temsirolimus, Rituximab, Bortezomib, Dexamethasone) | 0 | |
| Overall Study | COMPLETED | Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) | 6 | |
| Overall Study | COMPLETED | Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | 2 | |
| Overall Study | COMPLETED | Arm C (Phase I: Temsirolimus Dose Level 3, Rituximab, Bortezomib, Dexamethasone) | 0 | |
| Overall Study | COMPLETED | Arm D (Phase I: Temsirolimus Dose Level 4, Rituximab, Bortezomib, Dexamethasone) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events132
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) | 5 | 7 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | 1 | 2 | |
| other | Edema limbs | General disorders | Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) | 3 | 7 | |
| other | Edema limbs | General disorders | Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | 0 | 2 | |
| other | Fatigue | General disorders | Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) | 5 | 7 | |
| other | Fatigue | General disorders | Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | 1 | 2 | |
| other | Localized edema | General disorders | Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) | 1 | 7 | |
| other | Localized edema | General disorders | Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | 0 | 2 | |
| other | Pain | General disorders | Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) | 2 | 7 | |
| other | Pain | General disorders | Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | 0 | 2 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) | 1 | 7 |
| Total, all-cause mortality | Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | 0 | 2 |
| Total, other adverse events | Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) | 7 | 7 |
| Total, other adverse events | Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | 2 | 2 |
| Total, serious adverse events | Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) | 7 | 7 |
| Total, serious adverse events | Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | 1 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) vs Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone): deaths from any cause | Trial comparisons |
| Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) vs Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01381692
GET https://conductscience.org/api/trials/v1/NCT01381692/events?page=2