Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna (R-MACLO/VAM) in Patients With Previously Untreated Mantle Cell Lymphoma|
- Rate of Progression-Free Survival (PFS) [ Time Frame: 6, 12, 18 and 24 months Post-Treatment ]Rate of Progression-Free Survival (PFS) in study participants. PFS is defined as the time from start of treatment to the earliest one of the following events: relapse (in patients who achieve complete response), disease progression (in patients with partial response or stable disease), or death.
- Rate of Overall Survival (OS) [ Time Frame: 6, 12, 18 and 24 months Post-Treatment ]Rate of Overall Survival (OS) in study participants. Overall survival is defined as the length of time from the start of treatment until death from any cause.
- Rate of Response to Protocol Therapy [ Time Frame: End of Cycles 2 and 4, End of Treatment, Up to 5 years Post-Treatment ]Rate of response to protocol therapy in study participants. Response is defined as complete response (CR), complete response/unconfirmed (CRu) or partial response (PR) to protocol therapy according to criteria assignable to Non-Hodgkin's Lymphoma (NHL). Response assessment will be done by CT and Positron emission tomography (PET) scans, and bone marrow biopsy/aspirate, if clinically indicated.
- Rate of Treatment-Related Toxicity in Study Participants [ Time Frame: Up to the End of Protocol Therapy ]Rate of adverse events, serious adverse events and other toxicities related to protocol therapy in study participants.
|Actual Study Start Date:||March 25, 2009|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
Four 21-day cycles, followed by Maintenance Therapy as follows:
Granulocyte-colony stimulating factor (G-CSF) 480 mcg subcutaneously (SQ) starting on Day 13 of Cycles 1 and 3; and Day 7 of Cycles 2 and 4, per study protocol.
Other Names:Drug: Rituximab
Rituximab 375 mg/m^2 intravenously (IV) on Day 1 for 4 Cycles, per study protocol. For study participants achieving complete remission, during maintenance therapy every 6 months for up to three years, per study protocol.
Other Name: RituxanDrug: 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, per study protocol.
Other Name: CytoxanDrug: Cytarabine
Cytarabine 2 grams/m^2 IV on Days 1 and 2 of Cycles 2 and 4, per study protocol.
Other Name: AraCDrug: Doxorubicin
Doxorubicin 45 mg/m^2 IV bolus Day 1 of Cycles 1 and 3, per study protocol.
Other Name: AdriamycinDrug: Etoposide
Etoposide 60 mg/m^2 IV on Days 1 through 5 of Cycles 2 and 4, per study protocol.
Other Name: VP16Drug: Ifosfamide
Ifosfamide 1.5 grams/m^2 IV on Days 1 through 5 of Cycles 2 and 4, per study protocol.
Other Name: IfexDrug: 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 per study protocol.
Other Name: Folinic acidDrug: Mesna
Mesna 360 mg/m^2 IV on Days 1 through 5 of Cycles 2 and 4, per study protocol.
Other Name: MesnexDrug: Methotrexate
Methotrexate 1,200 mg/m^2 in 250 mL 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, per study protocol.
Other Name: MTXDrug: Vincristine
Vincristine 1.5 mg/m^2 IV push (maximum of 2 mg) on Days 1 and 8 of Cycles 1 and 3, per study protocol.
Other Name: Oncovin
This is a phase 2 study of Rituximab in combination with Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna (R-MACLO/IVAM) in subjects with previously untreated Mantle Cell Lymphoma (MCL). Treatment will consist of up to 4 cycles of therapy. Response assessment by CT and PET scans will be performed post Cycle 2. Once the final cycle of therapy is completed, response evaluation will be performed based on pre-study CT scans, PET/ Scan/endoscopy or any staging scans that were positive at baseline. (PI approval required if treating with less than 4 cycles).
Subjects in complete remission will be given Rituximab per institution guidelines, as 4 weekly doses every 6 months for a total of 3 years, or until progression of disease, or if the subject is unable to tolerate further treatment. Rituximab should begin 6 months from date of discharge +/- 21 days. Maintenance therapy, premedications can be changed based on clinical consideration from treating physician. Timelines for giving premedications are given per institutional guidelines. Subject may be discharged after administration of Rituximab, once stable.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878254
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33186|
|Contact: Izidore S. Lossos, MD 305-243-4785 firstname.lastname@example.org|
|Principal Investigator: Izidore S Lossos, MD|
|Principal Investigator:||Izidore S. Lossos, MD||University of Miami|