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NCT02339922 · REGISTRY CONDITION SEARCH

Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-07-01

This phase II trial studies how well ixazomib citrate and rituximab work in treating patients with B-cell non-Hodgkin lymphoma that grows slowly (indolent). Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving ixazomib citrate together with rituximab may work better in treating indolent B-cell non-Hodgkin lymphoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) in Patients With Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL)

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outcome · POSTED

ORR (CR + Very Good PR + PR + Minor Response) in Patients With Waldenstrom Macroglobulinemia (WM)/ Lymphoplasmacytic Lymphoma (LPL)

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outcome · POSTED

Duration of Response (DOR)

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outcome · POSTED

Progression-free Survival (PFS)

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outcome · POSTED

Overall Survival

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outcome · POSTED

CR Rate

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outcome · POSTED

Time to Next Therapy (TNT)

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outcome · POSTED

Incidence of Adverse Events (AEs)

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outcome · NOT POSTED

Identification of Clinical Features (i.e. Mantle Cell International Prognostic Score, Follicular Lymphoma International Prognostic Index Score, and International Prognostic Scoring System Score) and Biomarker Expression Levels

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outcome · NOT POSTED

Single Nucleotide Profile (SNP) Genotyping for PSMB1 P11A

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outcome · NOT POSTED

Gene Expression Profiling on Tumor Specimens

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outcome · NOT POSTED

Tumor Expression of Cluster of Differentiation 68, Nuclear Transcription Factor Kappa-B, p65, p27, and Proteasome Subunit, Alpha-type, 5 by Immunohistochemistry

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care * Female patients who: * Are postmenopausal for at least 1 year before the screening visit, OR * Are surgically sterile, OR * If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception) * Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: * Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception) * Patients must have a diagnosis of one of the following B-NHL malignancies: chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or Waldenstrom macroglobulinemia (WM)/ lymphoplasmacytic lymphoma (LPL); patients with mucosa associated lymphoid tissue (MALT) subtype of MZL may have relapsed or refractory disease after a course of antibiotic therapy; otherwise, patients will not have received standard systemic treatment for their B-NHL before the time of study enrollment; standard systemic therapy is defined by including any of the following agents, representing a comprehensive list of recommended front-line agents used in the treatment of B-NHL: cytotoxic chemotherapies (bendamustine, cyclophosphamide, doxorubicin, vincristine, chlorambucil, cytarabine, gemcitabine, platinum drugs, etoposide); anti-CD20 antibodies (obinutuzumab, ofatumumab, rituximab); lenalidomide; ibritumomab tiuxetan; proteasome inhibitors (bortezomib, carfilzomib); tyrosine kinase inhibitors (ibrutinib, acalabrutinib, idelalisib); alemtuzumab; corticosteroids unless given for an indication other than treating the B-NHL; or other therapy as determined by the principal investigator (PI) * Disease: CLL/SLL; Criteria for diagnosis: histopathologic or flow cytometric confirmation * Disease: FL; Criteria for diagnosis: histopathologic confirmation * Disease: MZL; Criteria for diagnosis: histopathologic confirmation * Disease: MCL; Criteria for diagnosis: histopathologic confirmation * Disease: WM/LPL; Criteria for diagnosis: Per World Health Organization (WHO) criteria * Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2 * Absolute neutrophil count (ANC) \>= 1,000/mm\^3 or \>= 500/mm\^3 if neutropenia is attributed to B-NHL (involvement of bone marrow) without growth factor support * Platelet count \>= 100,000/mm\^3 or \>= 75,000/mm\^3 if thrombocytopenia is attributed to B-NHL (involvement of bone marrow or due to splenomegaly or immune thrombocytopenic purpura); platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment * Total bilirubin =\< 1.5 x the upper limit of the normal range (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN * Calculated creatinine clearance \>= 30 mL/min * Patients are required to meet criteria for initiation of therapy for their B-NHL according to published guidelines by the National Comprehensive Cancer Network (NCCN) * Patients must have measurable disease defined by at least one of the following criteria: * Lesions greater than 1.5 cm that can be accurately measured in two dimensions by computed tomography (CT) (preferred), or magnetic resonance imaging (MRI), and are not included in any prior field of radiation given to treat B-NHL * In patients with CLL, circulating lymphocytes \>= 5,000 / mm\^3 * In patients with WM/LPL, measurable serum monoclonal immunoglobulin M (IgM) Exclusion Criteria: * Female patients who are lactating or have a positive serum pregnancy test during the screening period * Major surgery within 14 days before enrollment * Known central nervous system involvement * Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment * Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, cardiac arrhythmias, or congestive heart failure, and unstable angina or myocardial infarction within the past 6 months * Systemic treatment, within 14 days before the first dose of ixazomib, with strong inhibitors of cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of cytochrome P450, family 3, subfamily A (CYP3A) (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of ginkgo biloba or St. John's wort * Known ongoing or known active systemic infection, known active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive * Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol * Known allergy to ixazomib, its analogues, or excipients in the various formulations of ixazomib * Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing * Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed (\> 2 years before study enrollment) with another malignancy and have any evidence of residual disease that is symptomatic or requiring treatment; (this may be waived at the discretion of the principal investigator for patients in complete remission if they have not received systemic therapy); patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection * Patient has \>= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period * Participation in other clinical trials with other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial * Patients may not have impending organ compromise from disease as assessed by their treating physician * Prior treatment of B-NHL with radiation therapy, non-standard systemic therapy, or antibiotics (in cases of MZL) within 21 days of the first dose of ixazomib
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Ixazomib Citrate
    2. Other: Laboratory Biomarker Analysis
    3. Biological: Rituximab
    label
    Treatment (ixazomib citrate, rituximab)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (ixazomib citrate, rituximab)
    description
    Given PO
    name
    Ixazomib Citrate
    other Names
    1. MLN-9708
    2. MLN9708
    3. Ninlaro
    type
    DRUG
  2. arm Group Labels
    1. Treatment (ixazomib citrate, rituximab)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  3. arm Group Labels
    1. Treatment (ixazomib citrate, rituximab)
    description
    Given IV
    name
    Rituximab
    other Names
    1. ABP 798
    2. BI 695500
    3. C2B8 Monoclonal Antibody
    4. Chimeric Anti-CD20 Antibody
    5. CT-P10
    6. IDEC-102
    7. IDEC-C2B8
    8. IDEC-C2B8 Monoclonal Antibody
    9. MabThera
    10. Monoclonal Antibody IDEC-C2B8
    11. PF-05280586
    12. Rituxan
    type
    BIOLOGICAL
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
33
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. measure
    Identification of Clinical Features (i.e. Mantle Cell International Prognostic Score, Follicular Lymphoma International Prognostic Index Score, and International Prognostic Scoring System Score) and Biomarker Expression Levels
    time Frame
    Up to 5 years
  2. description
    SNP genotyping for PSMB1 P11A will be performed and will be correlated with response to ixazomib citrate and ixazomib citrate plus rituximab.
    measure
    Single Nucleotide Profile (SNP) Genotyping for PSMB1 P11A
    time Frame
    Up to 5 years
  3. description
    Will be correlated with response to rituximab.
    measure
    Gene Expression Profiling on Tumor Specimens
    time Frame
    Up to 5 years
  4. description
    Will be correlated with response to ixazomib citrate and ixazomib citrate plus rituximab.
    measure
    Tumor Expression of Cluster of Differentiation 68, Nuclear Transcription Factor Kappa-B, p65, p27, and Proteasome Subunit, Alpha-type, 5 by Immunohistochemistry
    time Frame
    Up to 5 years
primary Outcomes
  1. description
    ORR will be calculated for all treated patients for each disease cohort. The corresponding 95% two-sided confidence interval will be derived.
    measure
    Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) in Patients With Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL)
    time Frame
    Up to 5 years
  2. description
    ORR will be calculated for all treated patients for each disease cohort. The corresponding 95% two-sided confidence interval will be derived.
    measure
    ORR (CR + Very Good PR + PR + Minor Response) in Patients With Waldenstrom Macroglobulinemia (WM)/ Lymphoplasmacytic Lymphoma (LPL)
    time Frame
    Up to 5 years
secondary Outcomes
  1. description
    DOR will be calculated to determine durability. Non-responders will be excluded from the analysis of DOR. Kaplan Meier methodology will be used to estimate event-free curves.
    measure
    Duration of Response (DOR)
    time Frame
    From the time by which the measurement criteria are met for CR or PR, whichever is recorded first, until death or the first date by which recurrent or progressive disease is objectively documented, assessed up to 5 years
  2. description
    Data for subjects without disease progression or death will be censored at the date of the last tumor assessment. Kaplan-Meier methodology will be used to estimate the event-free curves.
    measure
    Progression-free Survival (PFS)
    time Frame
    Time from the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 years
  3. measure
    Overall Survival
    time Frame
    Up to 5 years
  4. measure
    CR Rate
    time Frame
    Up to 5 years
  5. description
    Data for subjects that have not received additional anti-neoplastic therapy will be censored at the date of last known contact.
    measure
    Time to Next Therapy (TNT)
    time Frame
    From the time of first study drug administration until the date of subsequent the first subsequent therapy given to treat the B-NHL, assessed up to 5 years
  6. description
    Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Safety summaries will include tabulations in the form of tables. The frequency of treatment-emergent AE's will be summarized. Additional AE summaries will include AE frequency by AE severity and relationship to the study drug. AE's requiring discontinuation of the study drug will be summarized separately, both overall and by AE severity and by relationship to the study drug. Clinically significant abnormal laboratory values will be summarized over study visits.
    measure
    Incidence of Adverse Events (AEs)
    time Frame
    Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months).
Full study description
brief Summary
This phase II trial studies how well ixazomib citrate and rituximab work in treating patients with B-cell non-Hodgkin lymphoma that grows slowly (indolent). Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving ixazomib citrate together with rituximab may work better in treating indolent B-cell non-Hodgkin lymphoma.
detailed Description
OUTLINE: Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 months for 3 years.
Source references
references
  1. citation
    Graf SA, Lynch RC, Ujjani CS, Gooley TA, Rasmussen H, Coffey DG, Cowan AJ, Smith SD, Shadman M, Warren EH, Libby EN, Greninger AL, Fromm JR, Gopal AK. Efficacy, safety, and molecular response predictors of oral ixazomib and short-course rituximab in untreated iNHL. Blood Adv. 2023 Mar 14;7(5):687-696. doi: 10.1182/bloodadvances.2022008628.
    pmid
    36385536
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice