Trial | NCT00026351  Report issue

Title

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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
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.
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 Started
Dec 31
2000
Study Completion
Jun 30
2003
Last Update
Feb 04
2013
Estimate

Biological rituximab

Drug pentostatin

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
No Results Posted