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
CompletedPhase 1, PHASE2Results postedLast updated 4 October 2021
What this trial tests
Phase 1, PHASE2 trial testing Bortezomib in Recurrent Follicular Lymphoma in 9 participants. Completed in 1 September 2021.
18 and older, any sex, with Recurrent Follicular Lymphoma or Recurrent Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase I: The Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Bortezomib, Rituximab and DexamethasonePrimary· 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.
Group
Value
95% CI
Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)
NA
Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)
NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)
Serious: 7/7 (100%)
Deaths: 1/7
Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)
This randomized phase I/II trial studies the side effects and the best dose of temsirolimus when given together with bortezomib, rituximab, and dexamethasone and to see how well they work compared to bortezomib, rituximab, and dexamethasone alone in treating patients with untreated or relapsed Waldenstrom macroglobulinemia or relapsed or refractory mantle cell or follicular lymphoma. Bortezomib and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. Monoclonal antibodies, such as rituximab, can block cancer growth in difference ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether bortezomib, rituximab, and dexamethasone are more effective with temsirolimus in treating non-Hodgkin lymphoma.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 4 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01381692.