CompletedPhase 1/2

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

United States9 participantsStarted 2011-07-20

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically proven diagnosis * For phase I portion (Arm A, B, C and D), patients must have of one of the following: * Relapsed Waldenstrom's macroglobulinemia * Relapsed/refractory mantle cell lymphoma; previous treatment with at least one standard regimen and no longer responsive to that regimen * Relapsed/refractory follicular lymphoma; previous treatment with at least one standard regimen and no longer responsive to that regimen * Relapsed/refractory marginal zone lymphoma; previous treatment with at least one standard regimen and no longer responsive to that regimen * Relapsed/refractory small lymphocytic lymphoma; previous treatment with at least one standard regimen and no longer responsive to that regimen * For phase II portion (Arm E and F), patients must have a diagnosis of symptomatic Waldenstrom's macroglobulinemia, either untreated or relapsed, confirmed by the presence of all of the following: * Bone marrow lymphoplasmacytosis with * \>= 10% lymphoplasmatic cells (measured within 28 days prior to registration) OR * Aggregates or sheets of one of the following: lymphocytes, plasma cells or lymphoplasmacytic cells on the bone marrow biopsy (measured within 28 days prior to registration) * Measurable disease defined as a quantitative immunoglobulin M (IgM) monoclonal protein of \>= 1000 mg/dL obtained within 28 days prior to registration * Cluster of differentiation 20 (CD20) positive bone marrow or lymph node by …

What they're measuring

Phase I: The Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Bortezomib, Rituximab and Dexamethasone

Timeframe: Assessed during cycle 1 (28 days)

Phase II: Progression-free Survival

Timeframe: 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

Trial details

NCT IDNCT01381692

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2014-12-08

Results submitted2021-04-09

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