Phase 2 N=81 Treatment

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

Leukemia · Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00278161 ↗

Enrolled (actual)

Serious AEs

18.5%

Results posted

Nov 2018

Primary outcome: Primary: Engraftment — 15; 15 days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pegfilgrastim (Biological); Rituximab (Biological); Cyclophosphamide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Engraftment	15; 15	—
PRIMARY Non-relapse Mortality	—	—
PRIMARY Event-free Survival	39; 40	—

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.

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00278161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.