Clinical Trials /

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

NCT00878254

Description:

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).

Related Conditions:
  • Mantle Cell Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 20080803
  • SECONDARY ID: SCCC-2008043
  • NCT ID: NCT00878254

Conditions

  • Mantle-Cell Lymphoma

Interventions

DrugSynonymsArms
G-CSFFilgrastim, NeupogenR-MACLO/IVAM
RituximabRituxanR-MACLO/IVAM
CyclophosphamideCytoxanR-MACLO/IVAM
CytarabineAraCR-MACLO/IVAM
DoxorubicinAdriamycinR-MACLO/IVAM
EtoposideVP16R-MACLO/IVAM
IfosfamideIfexR-MACLO/IVAM
LeucovorinFolinic acidR-MACLO/IVAM
MesnaMesnexR-MACLO/IVAM
MethotrexateMTXR-MACLO/IVAM
VincristineOncovinR-MACLO/IVAM

Purpose

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 Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
R-MACLO/IVAMExperimentalFour 21-day cycles, followed by Maintenance Therapy as follows: Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin, and G-CSF per study protocol. Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF per study protocol. Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years, per study protocol.
  • G-CSF
  • Rituximab
  • Cyclophosphamide
  • Cytarabine
  • Doxorubicin
  • Etoposide
  • Ifosfamide
  • Leucovorin
  • Mesna
  • Methotrexate
  • Vincristine

Eligibility Criteria

        Inclusion Criteria:

          1. Previously untreated, histologically confirmed mantle cell lymphoma,

          2. Measurable or evaluable disease (at least one site with >1.5 cm in diameter

          3. All stages are eligible

          4. Age > 18 years

          5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

          6. Adequate hepatic function:

               -  Bilirubin < 3 mg/dL

               -  Transaminases (serum glutamic oxaloacetic transaminase (SGOT) and/or serum
                  glutamate-pyruvate transaminase (SGPT)) < than 2.5 times the upper limit of
                  normal for the institution, unless due to lymphomatous involvement

          7. Serum creatinine< 1.5 mg/dl

          8. Ability to give informed consent

          9. Women of childbearing potential must have a negative pregnancy test within 72 hours of
             entering into the study. Males and females must agree to use adequate birth control if
             conception is possible during the study. Women must avoid pregnancy and men avoid
             fathering children while in the study.

         10. Life expectancy greater than 6 months.

        Exclusion Criteria:

          1. Previous chemotherapy, immunotherapy or radiotherapy for this mantle cell lymphoma

          2. Concurrent active malignancies, with the exception of in situ carcinoma of the cervix
             and basal cell carcinoma of the skin.

          3. Grade 3 or 4 cardiac failure and/or ejection fraction < 50.

          4. Psychological, familial, sociological or geographical conditions that do not permit
             treatment and/or medical follow-up required to comply with the study protocol.

          5. Patients with a known history of human immunodeficiency virus (HIV) or Acquired
             Immunodeficiency Syndrome (AIDS).

          6. Presence of hepatitis or hepatitis B virus (HBV) infection.

          7. Pregnant or breast-feeding women.

          8. Central Nervous System (CNS) involvement.
      
Maximum Eligible Age:72 Years
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Rate of Progression-Free Survival (PFS)
Time Frame:6, 12, 18 and 24 months Post-Treatment
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Rate of Overall Survival (OS)
Time Frame:6, 12, 18 and 24 months Post-Treatment
Safety Issue:
Description: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.
Measure:Rate of Response to Protocol Therapy
Time Frame:End of Cycles 2 and 4, End of Treatment, Up to 5 years Post-Treatment
Safety Issue:
Description: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.
Measure:Rate of Treatment-Related Toxicity in Study Participants
Time Frame:Up to the End of Protocol Therapy
Safety Issue:
Description:Rate of adverse events, serious adverse events and other toxicities related to protocol therapy in study participants.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:University of Miami

Trial Keywords

  • Mantle Cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • MCL
  • NHL

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