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

Phase 2

Completed

• Conditions: Leukemia; Lymphoma
• Interventions: Biological: Pegfilgrastim; Biological: Rituximab; Drug: Cyclophosphamide

• Registration Number: NCT00278161
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-01-16
• Study First Submitted QC: 2006-01-16
• Study First Posted: 2006-01-18
• Primary Completion: 2009-12
• Study Completion: 2011-07
• Status Verified: 2018-10
• Results First Submitted: 2018-10-04
• Results First Submitted QC: 2018-10-31
• Last Update Submitted: 2018-10-31
• Results First Posted: 2018-11-05
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R-HiCy	Rituximab	Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
R-HiCy	Pegfilgrastim	Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
R-HiCy	Cyclophosphamide	Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.

Primary Outcome Measures

Name	Time	Method
Non-relapse Mortality	5 years	Number of participants who died for reasons related to protocol treatment.
Event-free Survival	5 years	Percentage of participants alive without disease relapse.
Engraftment	Up to 43 days	Median days to neutrophil and platelet recovery. Neutrophil recovery is defined as absolute neutrophil count \>= 500 cells per microliter; platelet recovery is defined as untransfused platelet count \>= 20 \* 10\^9 cells per liter.

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States