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Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna (Maclo/Ivam) in Patients With Previously Untreated Mantle Cell Lymphoma


Phase 2
18 Years
64 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna (Maclo/Ivam) in Patients With Previously Untreated Mantle Cell Lymphoma


OBJECTIVES:

Primary

- Determine the progression-free survival of patients with previously untreated mantle
cell lymphoma treated with rituximab and combination chemotherapy comprising
vincristine, doxorubicin hydrochloride, cyclophosphamide, methotrexate, ifosfamide,
cytarabine, and etoposide followed by thalidomide.

Secondary

- Determine the overall survival of patients treated with this regimen.

- Determine the response rate in patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive rituximab IV and doxorubicin hydrochloride IV over 3-5 minutes on
day 1, vincristine IV on days 1 and 8, cyclophosphamide IV over 30 minutes on days 1-5,
methotrexate IV over 24 hours on day 10, and leucovorin calcium IV every 6 hours beginning
on day 11 and continuing until the level of methotrexate in the blood is within a safe
range. Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day
13 and continuing until blood counts recover. When absolute neutrophil count (ANC) reaches
1,500/mm^3, patients receive rituximab IV on day 1 (i.e., the day ANC reaches 1,500/mm^3),
ifosfamide IV over 1 hour on days 1-5, cytarabine IV over 3 hours every 12 hours on days 1
and 2, and etoposide IV over 1 hour on days 1-5. Patients also receive G-CSF SC once daily
beginning on day 7 and continuing until blood counts recover. Approximately 2-3 weeks later,
patients receive another course of therapy as above.

Patients in complete remission after 2 courses of rituximab and combination chemotherapy
receive oral thalidomide daily. Treatment with thalidomide continues for 1 year in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed monthly for 3 months, every 3
months for 2 years, every 6 months for 3-5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.


Inclusion Criteria:



DISEASE CHARACTERISTICS:

- Histologically confirmed mantle cell lymphoma

- All stages allowed

- Previously untreated disease

- Measurable or evaluable disease

- No CNS involvement

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy > 6 months

- Bilirubin < 3 mg/dL

- SGOT and/or SGPT < 2.5 times upper limit of normal (unless due to lymphomatous
involvement)

- Creatinine < 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception during and for ≥ 4
weeks after completion of study treatment (if receiving thalidomide)

- No other concurrent active malignancies, except for in situ carcinoma of the cervix
or basal cell carcinoma of the skin

Exclusion Criteria:

Grade 3-4 cardiac failure

- LVEF that is less than ≥ 50%

- psychological, familial, sociological, or geographical conditions that would preclude
study compliance

- known history of HIV or AIDS

- hepatitis or hepatitis B virus infection

PRIOR CONCURRENT THERAPY:

- Any prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 6, 12, 18, and 24 months

Outcome Time Frame:

6, 12, 18, and 24 months

Safety Issue:

No

Principal Investigator

Izidore S. Lossos, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20030165

NCT ID:

NCT00450801

Start Date:

April 2004

Completion Date:

April 2014

Related Keywords:

  • Lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage I mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136