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Imexon for Relapsed Follicular and Aggressive Lymphomas | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Imexon for Relapsed Follicular and Aggressive Lymphomas

A Phase II Study of Amplimexon® (Imexon for Injection) for the Treatment of Previously Treated Follicular and Aggressive Lymphoma in Adults

NCT01314014•University of Rochester

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether Amplimexon (imexon for injection) is effective in the treatment of indolent and aggressive lymphomas that have progressed after treatment with standard therapies.

Detailed Description

A phase II exploratory trial of imexon in lymphoma is justified by: (1) the observation of clinical activity (partial response to the drug observed in phase I testing in a subject with refractory indolent lymphoma); (2) the finding that imexon prevents the development of human immunoblastic lymphoma in SCID mice; (3) the finding that lymphoma cell lines are killed by readily achievable doses; and (4) translational studies implicating the importance of the redox state of the cancer cell. The dose and schedule chosen (1000 mg/m2 daily X 5 days every 3 weeks) is based on tolerability and subject acceptance in prior AmpliMed phase I studies. The planned correlative studies should help to identify potential biomarkers for response to imexon and provide further insight into potential mechanisms of imexon action hypothesized from results of prior laboratory studies.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis:
•Group 1: Histologically confirmed indolent NHL, including follicular (any grade), small lymphocytic lymphoma, marginal zone lymphoma and lymphoplasmacytic lymphomaGroup 2: histologically confirmed diffuse large B-cell, mantle cell, Burkitt, Burkitt-like, and diffuse large B-cell transformed from indolent non-Hodgkin's lymphoma.
•2. Prior treatment:
•Group 1: (indolent histologies): Patients must have demonstrated relapsed or refractory disease to 1 prior treatment regimen. The maximum number of prior regimens used for treatment is not specified.

Exclusion Criteria

•3. At least one target lesion, measurable by radiographic methods according to the 2007 Revised Response Criteria for Malignant Lymphoma.
•4. ECOG Performance Status 0-2.
•5. No clinical or laboratory evidence of central nervous system disease.
•6. Adult (age 18 years or older).
•7. Projected life expectancy \>4 months.
•8. If female, neither pregnant (negative pregnancy test required at screening) nor lactating.
•9. If of child-bearing potential, must be able to use and agree to use medically acceptable contraception for the duration of the study. For female subjects who are neither post-menopausal nor surgically sterilized, this includes oral or injectable hormonal methods, barrier methods such as an intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence. Male subjects must also agree to use an acceptable method for contraception for the duration of the study.
•10. No major infection or serious uncontrolled concomitant disease. Fully recovered from any major surgery.
•11. No evidence of other concurrent active malignancy.
•12. At least 4 weeks since any prior cancer chemotherapy (2 weeks for corticosteroids), antibody therapy, or radiotherapy.
+25 more criteria

Locations (2)

Arizona Cancer Center, University of Arizona

Tucson, Arizona, United States

University of Rochester Medical Center

Rochester, New York, United States

Key Dates

Start Date

May 1, 2011

Primary Completion Date

March 1, 2013

Completion Date

August 1, 2014

Last Updated

January 6, 2016

Enrollment

ACTUAL participants

Conditions

Follicular LymphomaSmall Lymphocytic LymphomaMarginal Zone LymphomaLymphoplasmacytic LymphomaDiffuse Large B Cell LymphomaMantle Cell LymphomaBurkitt's Lymphoma

Interventions

Imexon

DRUG

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

NCT06337318

Classic Follicular LymphomaFollicular Lymphoma With Unusual Cytological Features

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RECRUITINGPHASE1/PHASE2

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Imexon for Relapsed Follicular and Aggressive Lymphomas

Inclusion Criteria

Exclusion Criteria

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

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