NCT Number: NCT00026351
Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Cancer and Blood Institute of the Desert, Rancho Mirage, California, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
pentostatin
DrugSponsors and collaborators
Lead sponsor
Pharmatech Oncology
Industry
Registry information
Official study 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)
Important dates
- Study start
- 2000
- Study completion
- 2003
- First posted
- Jun 25, 2003
- Registry last updated
- Feb 4, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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