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A Phase II Clinical Trial of Denileukin Diftitox in Combination With Rituximab in Previously Untreated Follicular B-Cell Non-Hodgkin's Lymphoma

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Clinical Trial of Denileukin Diftitox in Combination With Rituximab in Previously Untreated Follicular B-Cell Non-Hodgkin's Lymphoma



- Determine the response rate (complete response [CR], unconfirmed CR, and partial
response) in patients with previously untreated stage III or IV follicular B-cell
non-Hodgkin's lymphoma treated with rituximab and denileukin diftitox.

- Assess the overall survival, time-to-progression, duration of response, and time-to-new
therapy in patients treated with this regimen.


- Determine whether this regimen depletes or inhibits the function of regulatory T cells
in these patients.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on days 1, 8, 15, and 22. Patients also receive denileukin
diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every
21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Blood is collected at baseline; on day 1 of courses 2-4; and 1 and 4 months after completion
of study treatment for research studies. Research studies include analysis of peripheral
blood lymphocyte subsets expressing CD3, CD4, CD8, CD19, CD25, and CD26 by flow cytometry;
quantitation of CD4+, CD25+ regulatory T cells by flow cytometry; tumor-specific
γ-interferon-secreting T cells by enzyme-linked immunospot assay; tumor-specific cytotoxic
T-lymphocyte activity; and immune activation by enzyme-linked immunosorbent assay.

After completion of study treatment, patients are followed periodically for up to 5 years
after registration.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

Inclusion Criteria


- Pathologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)

- Stage III or IV disease

- Grade 1 or 2 disease

- Previously untreated disease

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques

- Clearly defined bidimensional diameter ≥ 2 x 2 cm on physical examination OR >
2.0 cm in 1 of the dimensions by CT scan, MRI, or plain radiograph imaging

- Splenic enlargement may be used as a measurable parameter if the spleen is
palpable ≥ 3 cm below the left costal margin

- Circulating tumor cells < 5,000/mm³

- Must have paraffin-embedded tissue blocks/slides available

- No CNS lymphoma


- ECOG performance status 0-2

- Life expectancy ≥ 1 year

- WBC ≥ 3,400/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10.0 g/dL

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

- Alkaline phosphatase ≤ 3 times ULN

- AST ≤ 3 times ULN

- Creatinine ≤ 1.5 times ULN

- Albumin ≥ 3 g/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 year after
completion of study therapy

- No HIV infection

- No other active malignancies

- No active uncontrolled infection

- No known hypersensitivity to denileukin diftitox or any of its components, including
diphtheria toxin, aldesleukin, or excipients


- No prior chemotherapy, immunotherapy, vaccines, or radiotherapy for NHL

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of confirmed tumor response (complete response [CR], unconfirmed CR, and partial response)

Safety Issue:


Principal Investigator

Stephen M. Ansell, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

April 2008

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



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HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
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Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
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St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Lakeside Cancer Specialists, PLLC Saint Joseph, Michigan  49085
Fergus Falls Medical Group, PA Fergus Falls, Minnesota  56537
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Mary Rutan Hospital Bellefontaine, Ohio  43311
Grant Medical Center Cancer Care Columbus, Ohio  43215
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Adventist Medical Center Portland, Oregon  97216
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Mid Dakota Clinic, PC Bismarck, North Dakota  58501
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