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Completed

NCT Number: NCT00878254

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

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).

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Key information

Conditions

Mantle-Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami

Miami, Florida, 33186, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously untreated, histologically confirmed mantle cell lymphoma,
  • Measurable or evaluable disease (at least one site with >1.5 cm in diameter
  • All stages are eligible
  • Age > 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • 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
  • Serum creatinine< 1.5 mg/dl
  • Ability to give informed consent
  • 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.
  • Life expectancy greater than 6 months.

Exclusion criteria

  • Previous chemotherapy, immunotherapy or radiotherapy for this mantle cell lymphoma
  • Concurrent active malignancies, with the exception of in situ carcinoma of the cervix and basal cell carcinoma of the skin.
  • Grade 3 or 4 cardiac failure and/or ejection fraction < 50.
  • Psychological, familial, sociological or geographical conditions that do not permit treatment and/or medical follow-up required to comply with the study protocol.
  • Patients with a known history of human immunodeficiency virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS).
  • Presence of hepatitis or hepatitis B virus (HBV) infection.
  • Pregnant or breast-feeding women.
  • Central Nervous System (CNS) involvement.

Treatment and study plan

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.

Other names: Filgrastim, Neupogen

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.

Other names: Rituxan

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.

Other names: Cytoxan

Cytarabine

Drug

Cytarabine (AraC) 2 grams/m^2 IV on Days 1 and 2 of Cycles 2 and 4.

Other names: AraC

Doxorubicin

Drug

Doxorubicin 45 mg/m^2 IV bolus on Day 1 of Cycles 1 and 3.

Other names: Adriamycin

etoposide

Drug

Etoposide (VP16) 60 mg/m^2 IV on Days 1 through 5 of Cycles 2 and 4.

Other names: VP16

ifosfamide

Drug

Ifosfamide 1.5 grams/m^2 IV on Days 1 through 5 of Cycles 2 and 4.

Other names: Ifex

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.

Other names: Folinic acid

Mesna

Drug

Mesna 360 mg/m^2 IV on Days 1 through 5 of Cycles 2 and 4.

Other names: Mesnex

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.

Other names: MTX

Vincristine

Drug

Vincristine 1.5 mg/m^2 IV push (maximum of 2 mg) on Days 1 and 8 of Cycles 1 and 3.

Other names: Oncovin

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Up to 12 years

    Progression-Free Survival (PFS) among study participants. PFS is defined as the time in years 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.

  2. Progression-Free Survival (PFS) Rate at 5 Years Using Kaplan-Meier Method

    Time frame: 5 years

    Progression-Free Survival (PFS) rate at 5 years estimated by the Kaplan-Meier method will be reported as percentage probability of participants alive without relapse or disease progression at 5 years after starting study therapy. 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 outcomes

  1. Overall Survival (OS) Rate at 5 Years Using Kaplan-Meier Method

    Time frame: 5 years

    Overall Survival (OS) rate at 5 years estimated by the Kaplan-Meier method will be reported as percentage probability of survival beyond 5 years. OS is defined as elapsed time from start date of treatment to date of death from any cause. Alive participants will be censored at last date known to be alive.

  2. Rate of Response to Study Therapy

    Time frame: Up to 8 years

    The rate of response to study therapy will be reported as the number of participants achieving 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. Number of Participants Experiencing Treatment-Related Serious Adverse Events During R-MACLO/IVAM Induction Therapy

    Time frame: Up to 4 months

    The number of participants experiencing treatment-related serious adverse events (SAEs) during R-MACLO/IVAM induction therapy. AEs and SAEs will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0, as evaluated by treating physician.

  4. Number of Participants Experiencing Treatment-Related Adverse Events During R-MACLO/IVAM Induction Therapy

    Time frame: Up to 4 months

    The number of participants experiencing treatment-related adverse events (AEs) during R-MACLO/IVAM induction therapy. AEs and SAEs will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0, as evaluated by treating physician.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna (R-MACLO/IVAM) in Patients With Previously Untreated Mantle Cell Lymphoma

Important dates

Study start
2009
Primary completion
2024
Study completion
2025
First posted
Apr 8, 2009
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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