Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma

Summary

The investigator(s) hypothesize that Rituximab together with combination chemotherapy, followed by Rituximab maintenance therapy, will provide better disease control with improved response rates and overall survival in patients with previously untreated Mantle Cell Lymphoma (MCL).

Conditions

• Mantle-Cell Lymphoma

Interventions

BIOLOGICAL

G-CSF

Granulocyte-colony stimulating factor (G-CSF) 480 mcg subcutaneously starting on Day 13 of Cycles 1 and 3; and Day 7 of Cycles 2 and 4.

DRUG

Rituximab

Rituximab 375 mg/m\^2 intravenously (IV) on Day 1 for 4 Cycles during induction therapy. Participants achieving complete remission will then receive Rituximab maintenance therapy every 6 months for up to three years.

DRUG

Cyclophosphamide

Cyclophosphamide 800 mg/m\^2 IV on Day 1 and 200 mg/m\^2 IV on Days 2 through 5 of Cycles 1 and 3.

DRUG

Cytarabine

Cytarabine (AraC) 2 grams/m\^2 IV on Days 1 and 2 of Cycles 2 and 4.

DRUG

Doxorubicin

Doxorubicin 45 mg/m\^2 IV bolus on Day 1 of Cycles 1 and 3.

DRUG

Etoposide

Etoposide (VP16) 60 mg/m\^2 IV on Days 1 through 5 of Cycles 2 and 4.

DRUG

Ifosfamide

Ifosfamide 1.5 grams/m\^2 IV on Days 1 through 5 of Cycles 2 and 4.

DRUG

Leucovorin

Leucovorin 100 mg/m\^2 IV beginning 36 (+/-4) hours after start of Methotrexate infusion, and then 10 mg/m\^2 at 6 hour (+/- 30 min) intervals until Methotrexate level is \< 0.1 µmol/L during Cycles 1 and 3.

DRUG

Mesna

Mesna 360 mg/m\^2 IV on Days 1 through 5 of Cycles 2 and 4.

DRUG

Methotrexate

Methotrexate (MTX) 1,200 mg/m\^2 in 250 mL with Dextrose 5% in water (D5W) IV over 1 hour, followed by Methotrexate 3,000 mg/m\^2 in 1,000 mL D5W by continuous infusion over 23 (+/-2) hours on Day 10 of Cycles 1 and 3.

DRUG

Vincristine

Vincristine 1.5 mg/m\^2 IV push (maximum of 2 mg) on Days 1 and 8 of Cycles 1 and 3.

Sponsors & Collaborators

• University of Miami

  lead OTHER

Principal Investigators

• Izidore S. Lossos, MD · University of Miami

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-25

Primary Completion

2024-06-28

Completion

2025-05-30

FDA Drug

Yes

Countries

• United States

Study Locations