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

Sponsor

Pharmatech Oncology (Industry)

Overall Status

Completed

CT.gov ID

NCT00026351

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma	Biological: rituximab Drug: pentostatin	Phase 2

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.

Study Design

Study Type:

Interventional

Masking:

None (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)

Study Start Date :

Dec 1, 2000

Actual Study Completion Date :

Jun 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Cancer and Blood Institute of the Desert	Rancho Mirage	California	United States	92270
2	Redding Medical Center	Redding	California	United States	96001
3	Oncology-Hematology Associates, P.A.	Clinton	Maryland	United States	20735
4	North Shore Hematology/Oncology Associates, P.C.	East Setauket	New York	United States	11733
5	Hematology Oncology Associates of Central New York, P.C.	Syracuse	New York	United States	13210