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A Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non Hodgkin's Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non Hodgkin's Lymphoma

A Phase II Multicenter Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non-Hodgkins Lymphoma.

NCT00211276•Eisai Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical research study is to find out if the study drug, ONTAK (denileukin diftitox), can shrink or slow the growth of B-cell non-Hodgkin's lymphoma (NHL) in patients whose disease has not responded to prior treatments, or has relapsed after an initial response to prior treatments. The safety of treatment with ONTAK will also be studied. The hypothesis is that patients with relapsed or refractory B-cell NHL and mild to moderate myelosuppression treated with ONTAK at a new dosing regimen will respond sufficiently to warrant further study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Relapsed or refractory B-Cell NHL
•Histological documentation of diffuse large B-cell lymphoma, follicular lymphoma (grade 1, 2, or 3), small lymphocytic lymphoma or transformed B-Cell lymphoma.
•Bi-dimensionally measurable disease with at least one lymph node or tumor mass measuring \> or equal to 4 cm2
•ECOG performance status less than or equal to 2.
•Failure to respond or progression of disease after 2 or more prior treatment regimens; this may include high dose therapy (HDT) with stem cell transplantation (SCT). Patients with prior HDT plus SCT will be considered as having "diminished bone marrow reserve"
•At least 18 years of age
•At least 3 weeks from last anti-lymphoma therapy
•Mild to moderate cytopenia defined as any of the following:
•ANC \> or equal to 1,000/microL and \< 1,500/microL off growth factors
•WBC counts \> or equal to 2,000/microL and \< 4,000/microL off growth factors or
+9 more criteria

Exclusion Criteria

•Less than 6 months from prior allogeneic stem cell transplant and/or patient with active graft versus host disease (GVHD) Grade \> or equal to 2.
•Prior history of veno-occlusive disease of the liver.
•Inability to comply with protocol requirements of this study for intravenous administration of ONTAK.
•Pregnant women or lactating women who are breastfeeding or women planning to become pregnant during the treatment period.
•Serious intercurrent medical illnesses or active infections that, in the investigators opinion, might interfere with the interpretation of the study safety data or compromise the patients ability to carry out the treatment program.
•Known history of seropositivity for HIV or chronic hepatitis (testing for HIV is not required).
•Known hypersensitivity to ONTAK or any of its components: diptheria toxin, interleukin-2 or excipients.
•Experimental therapy within 4 weeks prior to study entry.
•Patients diagnosed with congestive heart failure, NYHA Class III or IV, ventricular tachycardia, fibrillation, or a history of myocardial infarction in the 12 months prior to study entry.
•Any prior radiation therapy within four weeks of enrollment, or prior radiation therapy to the only site of evaluable disease unless disease progression has occurred in that site.
+2 more criteria

Locations (12)

Tower Cancer Research Foundation

Beverly Hills, California, United States

Pacific Coast Hematology/Oncology

Fountain Valley, California, United States

University of California, Los Angeles

Los Angeles, California, United States

Emory University

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Siouxland Hematology-Oncology

Sioux City, Iowa, United States

Washington University Siteman Cancer Center

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

St. Vincent's Comprehensive Cancer Center

New York, New York, United States

Key Dates

Start Date

March 1, 2005

Primary Completion Date

January 1, 2007

Completion Date

February 1, 2007

Last Updated

March 14, 2012

Enrollment

ESTIMATED participants

Conditions

Lymphoma, B-Cell

Interventions

ONTAK (denileukin diftitox)

DRUG

Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma

NCT04161248

Lymphoma, B-Cell

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A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

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Lymphoma, B-CellLymphoma, Non-Hodgkin (NHL)+2 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: March 14, 2012Data 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.

View ClinicalTrials.gov Terms and Conditions

A Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non Hodgkin's Lymphoma

Inclusion Criteria

Exclusion Criteria

Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

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Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma