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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00211276
• Date of registration: 13/09/2005
• Primary sponsor: Eisai Inc.
• Public title: A Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non Hodgkin's Lymphoma
• Scientific title: A Phase II Multicenter Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non-Hodgkins Lymphoma.
• Date of first enrolment: March 2005
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00211276
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Myron Czuczman, MD
• Affiliation: Roswell Park Cancer Institute

Key inclusion & exclusion criteria

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

- Platelet count > or equal to 40,000/microL (25,000/microL if thrombocytopenia is
secondary to marrow involvement by lymphoma) and < 150,000/microL.

- Acceptable organ function defined as all of the following:

- Bilirubin < or equal to 1.5 times the upper limit of normal (ULN)

- SGOT (AST) and SGPT (ALT) < or equal to 2 times the ULN.

- Serum creatinine < 2 times ULN.

- Serum albumin > or equal to 3.0 g/dL

- Female patient of childbearing potential must have a negative pregnancy test within
seven days prior to study drug administration, and must agree to use an effective
means of contraception throughout the study.

- Life expectancy of at least 16 weeks.

- Patients must have reviewed, signed and dated a witnessed informed consent document
that has been approved by the IRB of each participating center.

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.

- Patients on concurrent corticosteroids as treatment for NHL. The use of tapering
doses or low doses of corticosteroids for resolving GVHD, or the use of
corticosteroids as premedication prior to ONTAK or as a transient treatment for
hypersensitivity reactions is permitted as necessary.

- History of prior malignancy within the preceding 5 years, except for successfully
treated cervical carcinoma in situ or basal cell carcinoma.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoma, B-Cell

Intervention(s)

Drug: ONTAK (denileukin diftitox)

Primary Outcome(s)

Disease Response will be evaluated by CT or MRI scans at baseline, every 8 weeks while on therapy, and every 3 months after therapy, using standard response criteria defined by Cheson et al.

Secondary Outcome(s)

Safety data will include laboratory, history and physical, and adverse events reports for both local and systemic signs or symptoms of study patients. Survival at one year post-therapy will also be assessed.

Secondary ID(s)

#123

Source(s) of Monetary Support

Please refer to primary and secondary sponsors