Know Cancer

or
forgot password

Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincritine, Ifosfamide, Etoposide, Cytarabine and Mesna (R-MACLO/VAM) in Patients With Previously Untreaded 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, Vincritine, Ifosfamide, Etoposide, Cytarabine and Mesna (R-MACLO/VAM) in Patients With Previously Untreaded Mantle Cell Lymphoma


OBJECTIVES:

Primary

- To evaluate progression-free survival of patients with previously untreated mantle cell
lymphoma treated with rituximab and combination chemotherapy comprising methotrexate,
doxorubicin hydrochloride, cyclophosphamide, leucovorin calcium, vincristine sulfate,
ifosfamide, etoposide, and cytarabine.

Secondary

- To evaluate overall survival of patients treated with this regimen.

- To evaluate the response rate in patients treated with this regimen.

- To evaluate the toxicity of this regimen in these patients.

OUTLINE:

- Courses 1 and 3: Patients receive rituximab IV and doxorubicin hydrochloride IV on day
1; vincristine sulfate IV on days 1 and 8; cyclophosphamide IV over 30 minutes on days
1-5; methotrexate IV continuously over 24 hours on day 10; leucovorin calcium IV every
6 hours beginning beginning 36 hours after start of methotrexate infusion and
continuing until methotrexate level is below 0.05 nM; and filgrastim (G-CSF)
subcutaneously (SC) beginning on day 13 and continuing until blood counts recover.

- Courses 2 and 4: Patients receive rituximab IV on day 1; cytarabine IV over 3 hours
every 12 hours on days 1 and 2; ifosfamide IV over 1 hour and etoposide IV over 1 hour
on days 1-5; and G-CSF SC beginning on day 7 and continuing until blood counts recover.

Patients who achieve complete remission after completion of course 4 receive rituximab IV
once weekly for 4 weeks. Treatment repeats every 6 months for up to 3 years 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 yearly thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed mantle cell lymphoma

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

- Serum creatinine < 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No grade 3-4 cardiac failure

- LVEF ≥ 50%

- No known history of HIV or AIDS

- No hepatitis or hepatitis B virus infection

- No other concurrent active malignancy, except carcinoma in situ of the cervix and
basal cell carcinoma of the skin

- No psychological, familial, sociological, or geographical conditions that would
prohibit treatment and/or medical follow-up required to comply with study protocol

PRIOR CONCURRENT THERAPY:

- No 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

Outcome Time Frame:

8 years

Safety Issue:

No

Principal Investigator

Izidore S. Lossos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20080803

NCT ID:

NCT00878254

Start Date:

March 2009

Completion Date:

December 2017

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