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Proteasome Inhibitor

Ixazomib for Lymphoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Brian Hill, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 months after beginning treatment
Awards & highlights

Study Summary

This trial is testing a new combination therapy for people with high risk indolent B cell lymphoma.

Eligible Conditions
  • Lymphoma
  • B-Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 months after beginning treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 months after beginning treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) of Oral Ixazomib
Secondary outcome measures
Duration of Response
Overall Response Rate
Overall Survival
+3 more

Side effects data

From 2021 Phase 4 trial • 45 Patients • NCT03416374
26%
Diarrhoea
23%
White blood cell count decreased
21%
Platelet count decreased
15%
Neutrophil count decreased
13%
Pneumonia
8%
Rash
8%
Anaemia
8%
Constipation
8%
Malaise
8%
Pyrexia
5%
Acute kidney injury
5%
Nasopharyngitis
5%
Influenza
3%
Pneumonia bacterial
3%
Tumour lysis syndrome
3%
Febrile neutropenia
3%
Prinzmetal angina
3%
Bile duct stone
3%
Gastroenteritis
3%
Interstitial lung disease
3%
Taste disorder
3%
Enterocolitis
3%
Duodenal ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
[Overall]; Combination Therapy + Ixazomib Therapy
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lenalidomide + Ixazomib + RituximabExperimental Treatment3 Interventions
Ixazomib 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Ixazomib
2017
Completed Phase 4
~3370
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

Brian Hill, MD, PhDLead Sponsor
2 Previous Clinical Trials
66 Total Patients Enrolled
2 Trials studying Lymphoma
66 Patients Enrolled for Lymphoma
Brian HillLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
1 Trials studying Lymphoma
36 Patients Enrolled for Lymphoma
The Cleveland ClinicOTHER
1,026 Previous Clinical Trials
1,366,057 Total Patients Enrolled
9 Trials studying Lymphoma
287 Patients Enrolled for Lymphoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Lenalidomide, Ixazomib, and Rituximab as Front-Line Therapy for High Risk Indolent B-Cell Lymphoma
Brian Hill 2017. "Lenalidomide, Ixazomib, and Rituximab as Front-Line Therapy for High Risk Indolent B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02898259.
~2 spots leftby Apr 2025
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