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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Previou

Brief Summary: 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).

Detailed Summary:

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.


Sponsor: University of Miami

Current Primary Outcome: 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.


Original Primary Outcome: Progression-free survival

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

Information By: University of Miami

Dates:
Date Received: April 7, 2009
Date Started: March 25, 2009
Date Completion: December 2019
Last Updated: March 16, 2017
Last Verified: March 2017