Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00026351
Recruitment Status : Completed
First Posted : June 25, 2003
Last Update Posted : February 4, 2013
Information provided by:
National Cancer Institute (NCI)

November 9, 2001
June 25, 2003
February 4, 2013
December 2000
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Complete list of historical versions of study NCT00026351 on Archive Site
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Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Phase II Multicenter Trial Of Pentostatin and Rituximab In Patients With Previously Treated and Untreated Low Grade B-Cell Non-Hodgkin's Lymphoma (NHL) Including Chronic Lymphocytic Leukemia (CLL)

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining pentostatin and rituximab in treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.


  • Determine the response rate in patients with low-grade B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with pentostatin and rituximab.
  • Determine the duration of response, median time to progression, and survival of patients treated with this regimen.
  • Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV alone on day 1 of course 1 only. Patients then receive rituximab IV and pentostatin IV on days 8, 15, and 22. An additional course with both drugs is administered on days 36, 43, and 50. Patients with progressive disease or a complete response receive no further treatment. Patients with responsive disease, but less than a complete response, receive one additional course of therapy as above.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 50 non-Hodgkin's lymphoma and 50 chronic lymphocytic leukemia patients will be accrued for this study.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
  • Biological: rituximab
  • Drug: pentostatin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2003
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  • Histologically confirmed low-grade non-Hodgkin's lymphoma

    • REAL classification:

      • B-cell chronic lymphocytic leukemia
      • Prolymphocytic leukemia
      • Small lymphocytic lymphoma
      • Follicular center lymphoma (grade I, II, or III)
      • Extranodal marginal zone B-cell lymphoma Malt type
    • International Working Group classification:

      • Small lymphocytic/chronic lymphocytic leukemia (CLL)

        • CLL with lymph node involvement allowed
      • Small lymphocytic plasmacytoid
      • Follicular small cleaved cell
      • Follicular mixed small and large cell
      • Follicular predominantly large cell
  • Measurable disease

    • Lymph node more than 1 cm in longest transverse diameter NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 6 months


  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 9 g/dL


  • Bilirubin no greater than 2.0 mg/dL
  • AST no greater than 5 times upper limit of normal


  • Creatinine less than 2.0 mg/dL
  • BUN normal
  • Urinalysis normal


  • LVEF normal in patients with history of stable heart disease for at least 2 years


  • HIV negative
  • No thyroid disease with thyroid function that cannot be maintained in the normal range
  • No other prior malignancy unless progression free for more than 5 years
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Prior rituximab, Y2B8, or iodine I 131 tositumomab allowed provided at least 6 months have elapsed and patient has had clear disease progression
  • No other concurrent immunotherapy


  • No more than 6 prior chemotherapy drugs
  • No more than 3 prior treatments with pentostatin
  • At least 3 weeks since prior chemotherapy
  • No prior cumulative lifetime dose of more than 480 mg/m2 of doxorubicin or an equivalent dose of any anthracycline
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • No concurrent radiotherapy to an indicator lesion


  • Not specified


  • No other concurrent investigational drug
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Pharmatech Oncology
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Study Chair: Judy Poehlman Pharmatech Oncology
National Cancer Institute (NCI)
July 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP