Ixazomib for Lymphoma

Phase-Based Estimates
1
Effectiveness
1
Safety
University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, OH
Lymphoma+2 More
Ixazomib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Lymphoma

Study Summary

This study is evaluating whether a combination of lenalidomide, ixazomib, and rituximab can be used as front-line therapy for high-risk indolent B cell lymphoma.

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Eligible Conditions

  • Lymphoma
  • Lymphoma, B-Cell
  • B Cell Lymphoma (BCL)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Ixazomib will improve 1 primary outcome and 6 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of Up to 15 months after beginning treatment.

Month 15
Maximum Tolerated Dose (MTD) of Oral Ixazomib
Month 15
Duration of Response
Overall Response Rate
Overall Survival
Progression Free Survival
Time to Progression
Time to Treatment Failure

Trial Safety

Trial Design

2 Treatment Groups

Control
Lenalidomide + Ixazomib + Rituximab

This trial requires 19 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ixazomib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Lenalidomide + Ixazomib + RituximabIxazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Rituximab
FDA approved
Ixazomib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 months after beginning treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 15 months after beginning treatment for reporting.

Closest Location

University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Lymphoplasmacytic lymphoma (including Waldenström's macroglobulinemia (WM))
Follicular lymphoma grades 1, 2, and 3a
Marginal zone B-cell lymphoma, including extranodal (MALT), nodal and splenic. Excluding: Small lymphocytic lymphoma Lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (WM)
Must have stage 2, 3 or 4 disease, with either high tumor burden by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria and/or Follicular Lymphoma International Prognostic Index (FLIPI) 3-5
Nodal or extranodal mass > 7 cm
At least 3 nodal masses: each > 3.0 cm in longest dimension
Systemic symptoms due to lymphoma or B symptoms
Splenomegaly with spleen > 16 cm by Computed Tomography (CT) scan
Evidence of compression syndrome (e.g., ureteral, orbital, gastrointestinal) or pleural or peritoneal serous effusion due to lymphoma (irrespective of cell content)
Leukemic presentation (> 5.0 x 10^9/L malignant circulating follicular or lymphoma cells)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for lymphoma?

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Common treatment options for lymphoma include surgery, radiation therapy, chemotherapy, targeted therapy and monoclonal antibody therapy. In some cases, some of the options are complementary and not mutually exclusive.

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What is lymphoma?

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Lymphoma manifests itself as either a relatively large or medium-sized, firm, non-calcified lymph nodule with necrosis. The lymphoid infiltrate is typically composed of mixed lymphocytic, polymorphic or monomorphic cells, varying amounts of which constitute the malignant neoplastic material. This contrasts with the morphological morphology. The malignant neoplastic cells contain non-lymphoblastic elements and are usually pleomorphic. A small percentage may have the morphology of a lymphocyte or a mast cell. We propose that neoplastic malignant cell types within lymphoma contain some malignant neoplastic elements with morphological and proliferative characteristics associated with this type of tumor.

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What are the signs of lymphoma?

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Signs of lymphoma include swollen lymph nodes and other masses, swollen lymph nodes on the neck and in the armpits, coughing up blood, enlarged liver (>5 cm) or spleen (>12 cm), enlarged spleen (<12 cm) and increased blood pressure.\n

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What causes lymphoma?

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Lymphoma develops because of a combination of the two factors, genetic predisposition and environmental trigger. It is a disease whose onset is often gradual and the cause of the disease does not have a well-known trigger. Lymphoma occurs as a result of an abnormal immune system response to cancer or other substances such as radiation, viral agents or some other environmental or chemical trigger. The exact cause of lymphoma is not known. Lymphoma occurs in the body in two types: non-Hodgkin's lymphoma (NHL) and Hodgkin's lymphoma (HL). Typically the cause is not well understood but seems to be associated with lifestyle, radiation exposure and infections.

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How many people get lymphoma a year in the United States?

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The number of new cancer cases due to lymphoma per year in the United States has doubled from 1970 to the present. The incidence of lymphoma continues to increase. Most patients with lymphoma present with non-Hodgkin's lymphoma. The incidence of Hodgkin ltumor is decreasing. The mean age of diagnosis has declined, with many of these patients diagnosed earlier in the 1970s.

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Can lymphoma be cured?

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The prognosis in dogs with lymphoma can be difficult to determine and is dependent upon the stage at which the diagnosis is made. Dogs that are still growing at the time of diagnosis are less likely to have a good prognosis and this is also true for dogs younger than 10 years. The long term prognosis for dogs with lymphoma and disease that has been stable but not cured is good and there is usually a complete recovery. These data support the inclusion of dogs with lymphoma in all trials investigating treatments for this disease, especially dogs with non-Hodgkin’s lymphoma but lymphoma in general.

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Have there been any new discoveries for treating lymphoma?

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There have been many groundbreaking and fruitful advances for treating this fatal malignancy. Future work will likely focus on understanding the genes involved in progression of the disease. Furthermore, research from various disciplines can hopefully lead to new forms of therapy in the future for patients with lymphoma.

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How does ixazomib work?

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Findings from a recent study show I-IXA significantly increased the percentage of MM cells in vivo and showed MM cell apoptosis in vitro, leading to the induction of an anti-myeloma response. The combination treatment of I-IXA with conventional therapy is being investigated, with promising results from phase I and II studies. Further results are expected from more advanced clinical trials, including trials with patients with refractory and relapsed MM.

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Does lymphoma run in families?

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Lymphoma in the family seems related to certain alleles of two genes encoding interleukins 2 and 5. The role of these cytokines in lymphoma is supported by the association of an increased risk of B cell lymphoma with chronic inflammation and by the presence of autoimmune disease in patients with sporadic B cell lymphoma. In contrast to previous studies, results of our family-based study suggest that a familial risk of lymphoma is not necessarily associated with a more aggressive sub type of the lymphoma.

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What is the latest research for lymphoma?

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The research for lymphoma is still young. Many scientific research findings depend on clinical trials, but it will take a long time before large-scale studies on subjects with lymphoma will provide sufficient data to recommend treatment choices. Patients with advanced disease who received one of the three recently approved agents have shown a significant (30%) median overall response and a high rate of sustained response, which is a positive indicator of long-term survival [11]. In addition, many new trials are still underway [21] as well as studies exploring the role of targeted therapies such as rituximab and anti-PD-1 combinations [12].

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What are the latest developments in ixazomib for therapeutic use?

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ixazomib is a novel orally active, clinically active first generation proteasome inhibitor currently undergoing clinical research. The drug is now in its late pre-clinical and clinical development phase in both solid tumors and hematologic malignancies. An effective first generation proteasome inhibitor with favourable safety profile could be a valuable therapeutic option.

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What is the primary cause of lymphoma?

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There is a broad range of triggers that have been associated with, or are suspected of causing, lymphoma. These risks are grouped under four broad categories: infections, genetic disorders, environmental factors and inflammation. The most frequently cited cause for lymphoma is infection. Chronic viral, fungal and parasitic infections are particularly prone to cause lymphomagenesis. This is especially true for Burkitt’s lymphoma and follicular lymphomas but there are cases that occur for almost 30 of these known cause. The most common cause of non-lymphoid lymphoma is lymphoproliferative disorders. A recent study reports that chronic Epstein-Barr (EBV) was found to be involved in approximately 75% of follicular lymphoma.

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