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Phase II Study of High Dose Cyclophosphamide and Rituximab in Low Grade and Mantle Cell Lymphoma


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Leukemia, Lymphoma

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Trial Information

Phase II Study of High Dose Cyclophosphamide and Rituximab in Low Grade and Mantle Cell Lymphoma


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Achievement of count recovery within 30 days

Safety Issue:

No

Principal Investigator

Lode J. Swinnen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000451458

NCT ID:

NCT00278161

Start Date:

January 2005

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • stage 0 chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • small lymphocytic lymphoma
  • stage I small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • B-cell chronic lymphocytic leukemia
  • splenic marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage I mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Waldenstrom macroglobulinemia
  • prolymphocytic leukemia
  • stage I marginal zone lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • refractory chronic lymphocytic leukemia
  • stage IV marginal zone lymphoma
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell

Name

Location
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410