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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00878254
Recruitment Status : Active, not recruiting
First Posted : April 8, 2009
Last Update Posted : August 19, 2022
Sponsor:
Information provided by (Responsible Party):
Izidore Lossos, MD, University of Miami

Study Description
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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).

Condition or disease Intervention/treatment Phase
Mantle-Cell Lymphoma Biological: G-CSF Drug: Rituximab Drug: Cyclophosphamide Drug: Cytarabine Drug: Doxorubicin Drug: Etoposide Drug: Ifosfamide Drug: Leucovorin Drug: Mesna Drug: Methotrexate Drug: Vincristine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Actual Study Start Date : March 25, 2009
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: R-MACLO/IVAM

Four 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.
 Biological: G-CSF
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:
  • Filgrastim
  • Neupogen

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: Rituxan

Drug: 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: Cytoxan

Drug: Cytarabine
Cytarabine 2 grams/m^2 IV on Days 1 and 2 of Cycles 2 and 4, per study protocol.
Other Name: AraC

Drug: Doxorubicin
Doxorubicin 45 mg/m^2 IV bolus Day 1 of Cycles 1 and 3, per study protocol.
Other Name: Adriamycin

Drug: Etoposide
Etoposide 60 mg/m^2 IV on Days 1 through 5 of Cycles 2 and 4, per study protocol.
Other Name: VP16

Drug: Ifosfamide
Ifosfamide 1.5 grams/m^2 IV on Days 1 through 5 of Cycles 2 and 4, per study protocol.
Other Name: Ifex

Drug: 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 acid

Drug: Mesna
Mesna 360 mg/m^2 IV on Days 1 through 5 of Cycles 2 and 4, per study protocol.
Other Name: Mesnex

Drug: 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: MTX

Drug: 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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Progression-Free Survival (PFS) [ Time Frame: Up to 8 years ]
    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. PFS will be evaluated by treating physician from staging Computed Tomography (CT) or Positron Emission Tomography (PET) scans.


Secondary Outcome Measures :
  1. Rate of Overall Survival (OS) [ Time Frame: Up to 8 years ]
    Rate of Overall Survival (OS) in study participants. OS is defined as the length of time from the start of treatment until death from any cause. OS will be evaluated by treating physician from staging CT or PET scans

  2. Rate of Response to Protocol Therapy [ Time Frame: Up to 8 years ]
    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.

  3. Rate of Treatment-Related Toxicity in Study Participants [ Time Frame: Up to 8 years ]
    Rate of adverse events, serious adverse events and other toxicities related to protocol therapy in study participants, as evaluated by treating physician.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878254


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33186
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Izidore S. Lossos, MD University of Miami
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Izidore Lossos, MD, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00878254    
Other Study ID Numbers: 20080803
SCCC-2008043 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Izidore Lossos, MD, University of Miami:
Non-Hodgkin's Lymphoma
MCL
NHL
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leucovorin
Cytarabine
Cyclophosphamide
Ifosfamide
Rituximab
Doxorubicin
 Methotrexate
Etoposide
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors