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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00026351
First received: November 9, 2001
Last updated: February 1, 2013
Last verified: July 2002
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Biological: rituximab
Drug: pentostatin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2000
Study Completion Date: June 2003
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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.

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 6 months

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

  • 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

Radiotherapy:

  • No concurrent radiotherapy to an indicator lesion

Surgery:

  • Not specified

Other:

  • No other concurrent investigational drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026351

Locations
United States, California
Cancer and Blood Institute of the Desert
Rancho Mirage, California, United States, 92270
Redding Medical Center
Redding, California, United States, 96001
United States, Maryland
Oncology-Hematology Associates, P.A.
Clinton, Maryland, United States, 20735
United States, New York
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, United States, 11733
Hematology Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13210
Sponsors and Collaborators
Pharmatech Oncology
Investigators
Study Chair: Judy Poehlman Pharmatech Oncology
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00026351     History of Changes
Other Study ID Numbers: CDR0000069021, PHARMATECH-N007, PHARMATECH-20001631, SUPERGEN-PHARMATECH-N007
Study First Received: November 9, 2001
Last Updated: February 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
refractory chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
prolymphocytic leukemia
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II small lymphocytic lymphoma
noncontiguous stage II marginal zone lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage I marginal zone lymphoma

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Pentostatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adenosine Deaminase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 19, 2014