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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT00450801
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 375 mg/m2 IV, Days 1 of all cycles
  • Cyclophosphamide — DRUG
    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.
  • Cytarabine — DRUG
    Cytarabine 2 grams/m2 IV every 12 hours x 4 doses, Days 1 and 2, Cycles 2 and 4.
  • Doxorubicin — DRUG
    Doxorubicin 45 mg/m2 IV bolus, Day 1, Cycles 1 and 3
  • Etoposide — DRUG
    Etoposide 60 mg/m2 IV daily x 5 days, Cycles 2 and 4
  • Ifosfamide — DRUG
    Ifosfamide 1.5 grams/m2 IV once a day (QD) x 5 days, Cycles 2 and 4
  • Leucovorin — DRUG
    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.
  • Methotrexate — DRUG
    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.
  • Thalidomide — DRUG
    Maintenance therapy.
  • Vincristine — DRUG
    Vincristine 1.5 mg/m2 IVP (maximum of 2 mg), Day 1 and 8 , Cycles 1 and 3.
  • Mesna — DRUG
    Mesna 360 mg/m2 IV every 3 hours x 5 days, Cycles 2 and 4
  • Filgrastim (G-CSF) — DRUG
    G-CSF 480 mcg subcutaneous (SQ) starting Day 13 (Cycles 1 and 3), Day 7 (Cycles 2 and 4)
  • Granisetron — DRUG
    Granisetron 1 mg IV on Day 1, Cycle 1 and 3
  • Decadron — DRUG
    Decadron 10 mg IV on Day 1, Cycles 1 and 3

Study Details

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.

Key Dates

Start date
Apr 30, 2004
Status verified
Oct 2015
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R-MACLO-IVAM-T
    Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.

Primary Outcome Measure

Progression-free Survival Rate [ Time Frame: Up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiamiFlorida33136-

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University of Miami Sylvester Comprehensive Cancer Center - Miami· Miami, FL

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