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A Phase II Multicenter Study of Ontak® (Denileukin Diftitox) in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Multicenter Study of Ontak® (Denileukin Diftitox) in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma


OBJECTIVES:

Primary

- Determine the efficacy of denileukin diftitox, in terms of objective response and time
to progression, in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Secondary

- Determine the safety of this drug in these patients.

- Determine the 1-year overall survival of patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive denileukin diftitox IV over 20-80 minutes on days 1-3, 8, 15, 22, 29, 36,
43, 50, 57, 64, 71, 78, 85, 92, and 99 (weeks 1-16) in the absence of disease progression or
unacceptable toxicity. Patients achieving a partial response at week 16 may continue
treatment once monthly for up to 8 additional doses or until a complete response (CR) is
achieved. Patients achieving a CR (at any time) receive 2 additional monthly doses of
denileukin diftitox beyond CR.

After completion of study treatment, patients are followed at 4 weeks and then every 3
months thereafter.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) of 1 of the following
subtypes:

- Diffuse large B-cell lymphoma

- Follicular lymphoma (grades 1-3)

- Small lymphocytic lymphoma

- Transformed B-cell lymphoma

- Relapsed or refractory disease

- Disease failed to respond to or progressed after ≥ 2 prior treatment regimens
(e.g., high-dose therapy [HDT] with stem cell transplantation [SCT]*) NOTE:
*Patients who have received HDT with SCT are considered to have diminished bone
marrow reserve

- Diminished bone marrow reserve AND/OR mild to moderate cytopenia, meeting 1 of the
following criteria:

- Absolute neutrophil count ≥ 1,000/mm^3 but < 1,500/mm^3 (growth factor
independent)

- WBC ≥ 2,000/mm^3 but < 4,000/mm^3 (growth factor independent)

- Platelet count ≥ 40,000/mm^3 (25,000/mm^3 if thrombocytopenia is secondary to
marrow involvement by lymphoma) but < 150,000/mm^3 (platelet transfusion
independent)

- At least 1 bidimensionally measurable lymph node or tumor mass ≥ 4 cm

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 16 weeks

Hematopoietic

- See Disease Characteristics

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2 times ULN

- Albumin ≥ 3.0 g/dL

- No history of veno-occlusive disease of the liver

- No chronic hepatitis

Renal

- Creatinine < 2 times ULN

Cardiovascular

- No congestive heart failure

- No New York Heart Association class III-IV cardiac disease

- No ventricular tachycardia

- No fibrillation

- No myocardial infarction within the past 12 months

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known HIV positivity

- No active GVHD ≥ grade 2 within the past 6 months

- No other serious medical illness or active infection that would preclude study
participation

- No known hypersensitivity to denileukin diftitox or any of its components (e.g.,
diphtheria toxin, interleukin-2, or their excipients)

- No other malignancy within the past 5 years except successfully treated carcinoma in
situ of the cervix or basal cell carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- At least 6 months since prior allogeneic SCT

- No concurrent immunotherapy

Chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- No concurrent anticancer hormonal therapy

- No concurrent corticosteroids for the treatment of NHL

- Concurrent corticosteroids allowed for the following conditions:

- Tapering doses of corticosteroids for resolving graft-versus-host disease (GVHD)

- Low-dose maintenance corticosteroids for the treatment of an autoimmune disorder

- Corticosteroids as premedication prior to denileukin diftitox administration or
as transient treatment for hypersensitivity reactions

Radiotherapy

- More than 4 weeks since prior and no concurrent radiotherapy

- No prior radiotherapy to the only site of evaluable disease unless disease
progression has occurred at that site

Surgery

- Not specified

Other

- At least 3 weeks since prior antilymphoma therapy

- More than 4 weeks since prior and no other concurrent experimental therapy, including
approved drugs tested in an investigational setting

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective clinical response (complete or partial response)

Safety Issue:

No

Principal Investigator

Lauren C. Pinter-Brown, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

LIGAND-PIND-123

NCT ID:

NCT00138164

Start Date:

December 2004

Completion Date:

November 2008

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent small lymphocytic lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781