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

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Macroglobulinemia Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström’s Macroglobulinaemia An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia Simvastatin in Waldenstrom’s Macroglobulinemia Ibrutinib (PCI-32765) in Waldenstrom’s Macroglobulinemia Carfilzomib, Rituximab and Dexamethasone in Waldenstrom’s Macroglobulinemia Thalidomide and Rituximab in Waldenstrom’s Macroglobulinemia Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia’s Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom’s Macroglobulinemia Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom’s Macroglobulinemia Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom’s Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing LBH589 in Relapsed or Relapsed and Refractory Waldenstrom’s Macroglobulinemia Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia A Phase II Trial of Ofatumumab in Subjects With Waldenstrom’s Macroglobulinemia Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia Expression of Ku70/XRCC6 in Waldenström’s Macroglobulinemia Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom’s Macroglobulinemia Study of VTD in Waldenstrom’s Macroglobulinemia Dasatinib In Waldenström Macroglobulinemia The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia CC-5013 (Lenalidomide) and Rituximab in Waldenstrom’s Macroglobulinemia Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom’s Macroglobulinemia Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia Efficacy of First Line B-RI for Treatment Naive Waldenström’s Macroglobulinemia Sildenafil Citrate in Waldenstrom’s Macroglobulinemia Bortezomib (Velcade) in Waldenstrom’s Macroglobulinemia Phase II Study of Campath-1H Antibody to Treat Waldenstrom’s Macroglobulinemia

Brief 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

Official Title

A Randomized Phase I/II Study of Bortezomib, Rituximab, Dexamethasone and Temsirolimus in Patients With Relapsed Waldenstrom Macroglobulinemia and Relapsed/Refractory Mantle Cell, Follicular, Marginal Zone or Small Lymphocytic Lymphomas (Phase I), and Untreated/Relapsed Waldenstrom Macroglobulinemia (Phase II)

Brief 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.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the maximum tolerated dose (MTD) of temsirolimus in combination with
      bortezomib, rituximab, dexamethasone in patients with relapsed Waldenstrom's
      macroglobulinemia and relapsed/refractory mantle cell, follicular, marginal zone or small
      lymphocytic lymphoma. (Phase I) II. To evaluate whether the addition of temsirolimus to the
      regimen of bortezomib, rituximab, dexamethasone improves progression-free survival in
      patients with previously untreated or relapsed Waldenstrom's macroglobulinemia. (Phase II)

      SECONDARY OBJECTIVES:

      I. To define and describe the toxicities of temsirolimus in combination with bortezomib,
      rituximab, and dexamethasone. (Phase I) II. To evaluate time to progression of bortezomib,
      rituximab, dexamethasone +/- temsirolimus in patients. (Phase II) III. To evaluate major and
      minor response by 6 cycles of therapy of bortezomib, rituximab, dexamethasone +/-
      temsirolimus. (Phase II) IV. To evaluate time to response and duration of response of
      bortezomib, rituximab, dexamethasone +/- temsirolimus. (Phase II) V. To evaluate toxicity of
      bortezomib, rituximab, dexamethasone +/- temsirolimus. (Phase II) VI. To evaluate time to
      next therapy of bortezomib, rituximab, dexamethasone +/- temsirolimus. (Phase II) VII. To
      evaluate overall survival of bortezomib, rituximab, dexamethasone +/- temsirolimus. (Phase
      II) VIII. To describe treatment-related fatigue, physical and functional well-being during
      and after treatment. (Phase II) IX. To compare the change in treatment related fatigue,
      physical and functional well-being over 6 cycles of bortezomib, rituximab, dexamethasone +/-
      temsirolimus. (Quality of Life) X. To prospectively assess health-related quality of life
      longitudinally (pre-treatment to 3 year follow-up assessment) among trial participants.
      (Quality of Life) XI. To describe treatment-related peripheral neuropathy associated with
      bortezomib neurotoxicity. (Quality of Life)

      OUTLINE: This is a phase I, dose-escalation study of temsirolimus followed by a randomized
      phase II study.

      PHASE I: Patients receive temsirolimus at 4 different dose levels (arms A, B, C and D)
      intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 22; rituximab IV over 30-60
      minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only); and bortezomib IV or
      subcutaneously (SC) and dexamethasone orally (PO) on days 1, 8, and 15. Courses repeat every
      28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

      PHASE II: Patients are randomized to 1 of 2 treatment arms.

      ARM E: Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses
      1 and 4 only) and bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment
      repeats every 28 days for 6 courses in the absence of disease progression or unacceptable
      toxicity.

      ARM F: Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and
      rituximab, bortezomib, and dexamethasone as in arm I. Treatment repeats every 28 days for 6
      courses in the absence of disease progression or unacceptable toxicity.

      After completion of study therapy, patients are followed up every 3 months for 2 years, every
      6 months for 3 years, and then yearly for 5 years.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Phase II: Time to Progression

Condition

Recurrent Follicular Lymphoma

Intervention

Bortezomib

Study Arms / Comparison Groups

 Arm A (Phase I: temsirolimus dose level 1, rituximab, bortezomib, dexamethasone)
Description:  Patients receive temsirolimus IV at dose level 1 (15mg) over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV at 375 mg/m2 over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV at 1.6 mg/m2 or SC and dexamethasone 20 mg PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

9

Start Date

July 20, 2011

Completion Date

December 8, 2014

Primary Completion Date

August 15, 2014

Eligibility Criteria

        Inclusion Criteria:

          -  For phase I portion (Arm A, B, C and D), patients must have of one of the following
             diagnoses:

               -  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
                  immunohistochemistry or flow cytometry obtained within 28 days prior to
                  registration

               -  Lymph node biopsy must be done =< 28 days prior to registration if used as an
                  eligibility criterion for study entry

               -  Serum protein electrophoresis (SPEP) is required to be performed within 28 days
                  prior to registration

          -  Additional requirements for Waldenstrom's macroglobulinemia (WM) patients (phase I and
             II; in addition to measurable disease, patients must have symptomatic disease defined
             by one or more of the following):

               -  Laboratory studies defining eligibility (hemoglobin [Hgb], platelet count,
                  viscosity) must have been obtained within 28 days prior to registration; if more
                  than one test was obtained, the most recent one will be utilized

               -  Hemoglobin <= 11 g/dL

               -  Hyperviscosity syndrome or measured viscosity level of >= 4 centipoise

                    -  NOTE: for these patients it is strongly recommended that they undergo
                       therapeutic plasmapheresis prior to initiation of therapy

               -  Platelet count < 100,000/mm^3

               -  Symptomatic lymphadenopathy, splenomegaly, or hepatomegaly

               -  Constitutional symptoms including fever, night sweats, or unexplained weight loss
                  (at least 10% of body weight in < 6 months)

               -  Symptomatic cryoglobulinemia

          -  Additional requirements for WM patients (phase I):

               -  Patients must have received previous treatment with at least one standard regimen
                  and are no longer responsive to that regimen

               -  There must have been at least 21 days since the last regimen and patient must
                  have recovered from any previous treatment-related toxicity to =< grade 1

          -  Additional requirements for WM patients (phase II):

               -  For previously treated patients, no more than 4 prior regimens are allowed

               -  If last regimen is with rituximab there must have been at least 6 months since
                  last rituximab dose, and if without rituximab there must have been at least 3
                  months since last regimen

          -  For all phase I patients, there must have been at least 21 days since last regimen and
             any previous non-hematologic treatment related toxicity must have resolved to =< grade
             1

          -  Prior irradiation is allowed if >= 28 days prior to registration have elapsed since
             the date of last treatment

          -  Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =<
             2.5 x institutional upper limit of normal (ULN), within 28 days prior to registration

               -  NOTE: in case one or both of these thresholds are exceeded, the patient can only
                  be included after initiation of appropriate lipid lowering medication; patients
                  cannot be enrolled if they do not meet these criteria on or off lipid lowering
                  medication; patients must start lipid lowering medication and cholesterol and
                  triglycerides must be below said levels before study entry

          -  Women of childbearing potential and sexually active males must use an accepted and
             effective method of contraception throughout the study and for 8 weeks following
             discontinuation of everolimus

          -  Platelets >= 75,000 mm^3

          -  Neutrophils >= 1,000 mm^3

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
             serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x
             institutional ULN

          -  Direct bilirubin =< 1.5 mg/dL

          -  Serum creatinine =< 2.5 mg/dL

          -  Patients must be tested for hepatitis B surface antigen (HBsAg) and hepatitis B core
             antibody (anti-HBc) within 28 days of registration and will not be eligible if found
             to be positive

          -  Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of <=
             2

        Exclusion Criteria:

          -  Receiving concurrent steroids > 10 mg prednisone (or equivalent) per day

          -  Prior exposure to mammalian target of rapamycin (m-TOR) inhibitors (sirolimus,
             temsirolimus, everolimus)

          -  Pregnant or breast-feeding; all females of childbearing potential must have a blood
             test or urine study within 2 weeks prior to registration to rule out pregnancy; a
             female of childbearing potential is any woman, regardless of sexual orientation or
             whether they have undergone tubal ligation, who meets the following criteria: 1) has
             not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
             postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in
             the preceding 24 consecutive months)

          -  History of prior malignancy except for adequately treated basal cell or squamous cell
             skin cancer or in-situ cervical cancer; the patient may also have had other cancer for
             which the patient was curatively treated with surgery alone and from which the patient
             has been disease free for >= 5 years

          -  Severe and/or uncontrolled medical condition or other conditions that could affect
             their participation in the study, including, but not restricted to:

               -  Symptomatic congestive heart failure of New York Heart Association class III or
                  IV

               -  Unstable angina pectoris, symptomatic congestive heart failure, myocardial
                  infarction within 3 months of start of study treatment, serious uncontrolled
                  cardiac arrhythmia or any other clinically significant heart disease

               -  Severely impaired lung function as defined as spirometry and diffusing capacity
                  of the lung for carbon monoxide (DLCO) (corrected for Hgb) that is < 50% of the
                  normal predicted value and/or oxygen (O2) saturation < 88% at rest on room air

               -  Active (acute or chronic) or uncontrolled severe infections

          -  Grade 2 or higher neuropathy

          -  Concurrent use of angiotensin-converting enzyme (ACE) inhibitors (angioedema), and no
             concurrent use of strong cytochrome P450, family 3, subfamily A, polypeptide 4
             (CYP3A4) inducers and inhibitors
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Leonard T Heffner, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01381692

Organization ID

NCI-2011-02650

Secondary IDs

NCI-2011-02650

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Collaborators

 ECOG-ACRIN Cancer Research Group

Study Sponsor

Leonard T Heffner, Principal Investigator, ECOG-ACRIN Cancer Research Group


Verification Date

April 2021