Rituximab, Cyclophosphamide, and Pegfilgrastim in Treating Patients With Leukemia or Non-Hodgkin's Lymphoma

NCT ID: NCT00278161

Last Updated: 2018-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2011-07-31

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving rituximab and cyclophosphamide together with pegfilgrastim may be effective in treating leukemia or non-Hodgkin's lymphoma.

PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide together with pegfilgrastim works in treating patients with B-cell leukemia, low-grade non-Hodgkin's lymphoma, or mantle cell lymphoma.

Detailed Description

OBJECTIVES:

• Determine the safety of high-dose cyclophosphamide, rituximab, and pegfilgrastim in patients with B-cell leukemia or low-grade or mantle cell lymphoma.
• Determine the molecular response rate in patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive rituximab IV over 30-60 minutes on days 1, 4, 8,11, 45, and 52, cyclophosphamide IV over 1 hour on days 15-18, and pegfilgrastim subcutaneously on day 19 or 20 in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Conditions

Leukemia; Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-HiCy

Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.

Group Type: EXPERIMENTAL

Pegfilgrastim

Intervention Type: BIOLOGICAL

6 mg SQ 24-48 hours after last dose of cyclophosphamide.

Rituximab

Intervention Type: BIOLOGICAL

375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.

Cyclophosphamide

Intervention Type: DRUG

50 mg/kg/day on Days 15, 16, 17, and 18.

Interventions

Pegfilgrastim

6 mg SQ 24-48 hours after last dose of cyclophosphamide.

Intervention Type: BIOLOGICAL

Rituximab

375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.

Intervention Type: BIOLOGICAL

Cyclophosphamide

50 mg/kg/day on Days 15, 16, 17, and 18.

Intervention Type: DRUG

Other Intervention Names

Neulasta; Rituxan; Cytoxan; Cy; CTX

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• One of the following B-cell leukemias or lymphomas, as defined by World Health Organization criteria:

• Chronic lymphocytic leukemia/small lymphocytic lymphoma
• B-cell prolymphocytic leukemia
• Lymphoplasmacytic leukemia
• Marginal zone lymphoma (splenic, extranodal, or nodal)
• Follicular lymphoma (grade 1 or 2)
• Mantle cell lymphoma
• No more than minimal (approximately 10%) morphologically identifiable cancer cells on bone marrow biopsy

• When cancer cells are morphologically difficult to distinguish from normal cells, flow cytometry must show no more than 10% identifiable cancer cells
• Must have received ≤ 12 months of prior cytotoxic therapy, achieving at least a partial response 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:

• ECOG performance status 0-1
• WBC ≥ 3,000/mm^3
• Hemoglobin ≥ 10.0 g/dL
• Platelet count ≥ 75,000/mm^3
• Serum creatinine ≤ 2.0 mg/dL
• Total bilirubin ≤ 2 mg/dL unless secondary to tumor
• AST or ALT < 2 times upper limit of normal
• Normal (≥ 45%) left ventricular cardiac ejection fraction (determined by echocardiogram or MUGA scan)
• DLCO > 50% predicted
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No known sensitivity to E. coli-derived products (e.g. filgrastim [G-CSF], insulin, asparaginase, growth hormone, or recombinant interferon alfa-2b) or any treatment study drugs
• No active infections requiring oral or intravenous antibiotics
• No other second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix unless the malignancy was localized and treated or resected with > 90% probability of cure

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Prior anti-CD20 therapy allowed provided patient achieved a partial or complete response
• No concurrent steroids during rituximab administration

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lode J. Swinnen, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

References

Gladstone DE, Bolanos-Meade J, Huff CA, Zahurak M, Flinn I, Borrello I, Luznik L, Fuchs E, Kasamon Y, Matsui W, Powell J, Levitsky H, Brodsky RA, Ambinder R, Jones RJ, Swinnen LJ. High-dose cyclophosphamide and rituximab without stem cell transplant: a feasibility study for low grade B-cell, transformed and mantle cell lymphomas. Leuk Lymphoma. 2011 Nov;52(11):2076-81. doi: 10.3109/10428194.2011.594191. Epub 2011 Jul 14.

Reference Type: RESULT

PMID: 21756035 (View on PubMed)

Other Identifiers

P50CA096888

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00041511

Identifier Type: OTHER

Identifier Source: secondary_id

J0260

Identifier Type: -

Identifier Source: org_study_id