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

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

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

Trial Locations (1)

33136

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami

All Listed Sponsors
lead

University of Miami

OTHER

NCT00450801 - R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma | Biotech Hunter | Biotech Hunter