R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma

Summary

RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma.

Conditions

• Lymphoma

Interventions

DRUG

Rituximab

Rituximab 375 mg/m2 IV, Days 1 of all cycles

DRUG

Cyclophosphamide

Cyclophosphamide 800 mg/m2 IV, Day 1, Cyclophosphamide 200 mg/m2 IV Days 2 - 5, Cycles 1 and 3. Cyclophosphamide will be given in 100 cc NS IV over 30 minutes.

DRUG

Cytarabine

Cytarabine 2 grams/m2 IV every 12 hours x 4 doses, Days 1 and 2, Cycles 2 and 4.

DRUG

Doxorubicin

Doxorubicin 45 mg/m2 IV bolus, Day 1, Cycles 1 and 3

DRUG

Etoposide

Etoposide 60 mg/m2 IV daily x 5 days, Cycles 2 and 4

DRUG

Ifosfamide

Ifosfamide 1.5 grams/m2 IV once a day (QD) x 5 days, Cycles 2 and 4

DRUG

Leucovorin

Leucovorin 180 mg/m2 IV beginning 36 hours after start of methotrexate infusion and then 12 mg/m2 IV every 6 hours until methotrexate level is below 0.01 nM. Day 10, Cycles 1 and 3.

DRUG

Methotrexate

Methotrexate 1,200 mg/m2 in 250 cc 5 percent dextrose in water (D5W) IV over 1 hour followed by Methotrexate 5,520 mg/m2 in 1,000 cc D5W by continuous infusion over 23 hours (240 mg/m2 every hour for 23 hours). Day 10, Cycles 1 and 3.

DRUG

Thalidomide

Maintenance therapy.

DRUG

Vincristine

Vincristine 1.5 mg/m2 IVP (maximum of 2 mg), Day 1 and 8 , Cycles 1 and 3.

DRUG

Mesna

Mesna 360 mg/m2 IV every 3 hours x 5 days, Cycles 2 and 4

DRUG

Filgrastim (G-CSF)

G-CSF 480 mcg subcutaneous (SQ) starting Day 13 (Cycles 1 and 3), Day 7 (Cycles 2 and 4)

DRUG

Granisetron

Granisetron 1 mg IV on Day 1, Cycle 1 and 3

DRUG

Decadron

Decadron 10 mg IV on Day 1, Cycles 1 and 3

Sponsors & Collaborators

• University of Miami

  lead OTHER

Principal Investigators

• Izidore S. Lossos, MD · University of Miami Sylvester Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-04-30

Primary Completion

2015-07-31

Completion

2015-07-31

Countries

• United States

Study Locations