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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT00878254
Phase
PHASE2
Status
Completed

Conditions

  • Mantle-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • G-CSF — BIOLOGICAL
    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.
  • Rituximab — DRUG
    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.
  • Cyclophosphamide — DRUG
    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.
  • Cytarabine — DRUG
    Cytarabine (AraC) 2 grams/m\^2 IV on Days 1 and 2 of Cycles 2 and 4.
  • Doxorubicin — DRUG
    Doxorubicin 45 mg/m\^2 IV bolus on Day 1 of Cycles 1 and 3.
  • Etoposide — DRUG
    Etoposide (VP16) 60 mg/m\^2 IV on Days 1 through 5 of Cycles 2 and 4.
  • Ifosfamide — DRUG
    Ifosfamide 1.5 grams/m\^2 IV on Days 1 through 5 of Cycles 2 and 4.
  • Leucovorin — DRUG
    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.
  • Mesna — DRUG
    Mesna 360 mg/m\^2 IV on Days 1 through 5 of Cycles 2 and 4.
  • Methotrexate — DRUG
    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.
  • Vincristine — DRUG
    Vincristine 1.5 mg/m\^2 IV push (maximum of 2 mg) on Days 1 and 8 of Cycles 1 and 3.

Study Details

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).

Key Dates

Start date
Mar 25, 2009
Status verified
Jul 2025
Primary completion
Jun 28, 2024
Completion
May 30, 2025

Study Design

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

Arms

  • Experimental: R-MACLO/IVAM Group
    Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows: Induction Therapy: * Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin and Granulocyte-colony stimulating factor (G-CSF) * Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF. Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years. Total participation duration is about 4 years. Participants will be followed for survival.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 12 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33186-

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By research site
University of Miami· Miami, FL

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