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Follicular LymphomaPhase 2ULYM11011NCT01314014

Imexon for Relapsed Follicular and Aggressive Lymphomas

A Phase 2 study testing Imexon in people with Follicular Lymphoma and Small Lymphocytic Lymphoma, run by University of Rochester at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Imexon
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesUnited States
Study dates
May 2011to Aug 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • Group 2: (aggressive histologies): Patients must have demonstrated relapsed or refractory disease to at least 1 prior treatment regimen. In the case of de novo diffuse large B-cell lymphoma, prior treatment must include R-CHOP or R-CHOP-like therapy, as well as second line autologous stem cell transplantation unless the patient is not eligible. The maximum number of prior regimens is not specified.
  • At least one target lesion, measurable by radiographic methods according to the 2007 Revised Response Criteria for Malignant Lymphoma.
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  • ECOG Performance Status 0-2.
  • No clinical or laboratory evidence of central nervous system disease.
  • Adult (age 18 years or older).
  • Projected life expectancy >4 months.
  • If female, neither pregnant (negative pregnancy test required at screening) nor lactating.
  • 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.
  • No major infection or serious uncontrolled concomitant disease. Fully recovered from any major surgery.
  • No evidence of other concurrent active malignancy.
  • At least 4 weeks since any prior cancer chemotherapy (2 weeks for corticosteroids), antibody therapy, or radiotherapy.
  • Prior radiotherapy to less than an estimated 25% of the bone marrow. In addition, the target lesion(s) must not have been previously irradiated.
  • Clinical laboratory values within the following limits:
  • Hgb >/=10.0 g/dL
  • Absolute neutrophil count ANC >/=1,500/mm3
  • Platelets >/=75,000/mm3
  • Serum creatinine </=2.0 times upper limit of normal
  • Serum bilirubin </=2.0 times upper limit of normal
  • Serum AST and ALT </=3 times upper limit of normal
  • G6PD level >/= lower limit of normal
  • Able and willing to render informed consent and to follow protocol requirements.

Who cannot join

  • Diagnosis of lymphoma based on fine needle aspirate.
  • Curative therapy is indicated or possible.
  • Absence of a measurable target lesion, or the only target lesion was previously irradiated.
  • Symptoms, exam findings, or laboratory findings to suggest central nervous system disease involvement.
  • Age < 18 years
  • Projected life expectancy <4 months.
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  • Pregnant or lactating.
  • Unable or unwilling to use medically acceptable contraception, if of childbearing potential.
  • Evidence of major infection or other serious uncontrolled concomitant illness. Not fully recovered from prior major surgery.
  • Evidence of other active malignancy.
  • Prior radiotherapy, antibody therapy, or cancer chemotherapy within 4 weeks before start of treatment (2 weeks for corticosteroids). Prior radiotherapy to >25% of the bone marrow.
  • Clinical laboratory values outside of permitted ranges.
  • Respiratory insufficiency requiring oxygen therapy; angina at rest, or myocardial infarction in previous 3 months; history of life threatening ventricular arrhythmia; uncompensated CHF or NYHA Grade 3 or 4 cardiac disease.
  • Unable or unwilling to give informed consent and to follow protocol requirements.
  • Failure to meet any of the eligibility criteria.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Arizona Cancer Center, University of Arizona

    Tucson, Arizona, 85724

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Imexon
Keywords
Non Hodgkin's Lymphoma, Lymphoma, Low Grade, Lymphoma, Intermediate Grade, Lymphoma, High Grade, Lymphoma, B Cell
Medical subject headings
Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Burkitt Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImexonDrug

    Also called Amplimexon (imexon for injection)

    Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.

Study groups in NCT01314014
Study groupRoleWhat they receive
ImexonExperimentalSubjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.
Receives: Drug: Imexon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate of of Participants to Imexon in the Treatment of Relapsed/Refractory Indolent and Aggressive Lymphomas

    CT, PET, or MRI scans for the assessment of objective tumor responses were performed at baseline, after cycle 2, and every 3 cycles thereafter until disease progression. Standard response criteria from the International Harmonization Project on Lymphoma were used for classification of objective tumor responses. Response was defined as PR (Regression of measuable disease and no new sites) if >= 50% decrease in sum of the product of the diameters of up to 6 largest dominant masses; no increase in size of other nodes (a) [18F]fluorodeoxyglucose (FDG)-avid or PET prior to therapy; one or more (PET) positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.

    Measured: One year

Secondary outcomes (1)

  1. Median Time to Progression Free Survival in Participants With Relapsed/Refractory Indolent and Aggressive Lymphomas

    Measured from start of treatment until disease progression or death from any cause.

    Measured: up to 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionMar 2013
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01314014
Sponsor's protocol ID
36191
Acronym
ULYM11011
Status last verified
Dec 2015
First submitted
10 Mar 2011
Last updated
6 Jan 2016
Data monitoring committee
Yes

Publications

  • Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

    PubMed 17242396

  • Barr PM, Miller TP, Friedberg JW, Peterson DR, Baran AM, Herr M, Spier CM, Cui H, Roe DJ, Persky DO, Casulo C, Littleton J, Schwartz M, Puvvada S, Landowski TH, Rimsza LM, Dorr RT, Fisher RI, Bernstein SH, Briehl MM. Phase 2 study of imexon, a prooxidant molecule, in relapsed and refractory B-cell non-Hodgkin lymphoma. Blood. 2014 Aug 21;124(8):1259-65. doi: 10.1182/blood-2014-04-570044. Epub 2014 Jul 11.

    PubMed 25016003

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imexon in people with Follicular Lymphoma and Small Lymphocytic Lymphoma, run by University of Rochester at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate of of Participants to Imexon in the Treatment of Relapsed/Refractory Indolent and Aggressive Lymphomas (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01314014, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2016.

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