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A Phase II Trial of Cisplatinum, Cytosine Arabinoside, Dexamethasone (DHAP) With Rituxan in Patients With Relapsed CD20+ B-Cell Non-Hodgkin's Lymphoma

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

A Phase II Trial of Cisplatinum, Cytosine Arabinoside, Dexamethasone (DHAP) With Rituxan in Patients With Relapsed CD20+ B-Cell Non-Hodgkin's Lymphoma


- Determine response rate to cisplatin, cytarabine, and dexamethasone (DHAP) plus
rituximab in patients with relapsed CD20+ B-cell non-Hodgkin's lymphoma.

- Determine the percentage of patients able to proceed to transplant after two courses of
this treatment regimen.

- Determine the duration of response and overall survival of the patients not proceeding
to transplant after two courses of this treatment regimen.

OUTLINE: Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only.
Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24
hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and
sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover.
Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6
months for 3 years.

PROJECTED ACCRUAL: A total of 17-50 patients will be accrued for this study within 11

Inclusion Criteria


- Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma

- Relapsed following chemotherapy and eligible for platinum-containing regimen

- Measurable disease

- Must be at least 1.5 x 1.5 cm



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 75,000/mm^3


- Bilirubin no greater than 2.0 mg/dL


- Creatinine no greater than 1.5 times upper limit of normal


- No uncontrolled hypertension


- HIV negative

- No other active malignancy

- No uncontrolled diabetes mellitus

- No uncontrolled peptic ulcer disease

- No uncontrolled infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- See Disease Characteristics

Endocrine therapy:

- Not specified


- Not specified


- Not specified

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Thomas E. Witzig, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

October 2000

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Mayo Clinic Jacksonville, Florida  32224
Medcenter One Health System Bismarck, North Dakota  58501
CentraCare Health Plaza Saint Cloud, Minnesota  56303