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Completed

NCT Number: NCT00450801

R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma

RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases 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 Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

About this study

OBJECTIVES:

Primary

  • Determine the progression-free survival of patients with previously untreated mantle cell lymphoma treated rituximab in combination with methotrexate, doxorubicin, cyclophosphamide, leucovorin, vincristine, ifosfamide, etoposide, cytarabine and mesna (MACLO/IVAM) followed by thalidomide.

Secondary

  • Determine the overall survival of patients treated with this regimen.
  • Determine the response rate in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: During cycle 1, patients will receive rituximab intravenous (IV), granisetron IV, decadron IV, doxorubicin IV bolus, vincristine intravenous pyelogram (IVP) on day 1; cyclophosphamide IV on day 1-5; vincristine IVP on day 8; methotrexate IV, methotrexate by continuous infusion, then leucovorin IV until methotrexate level is below 0.01 nanomolar (nM) on day 10. Patients will receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 13 and continuing until blood counts recover.

When absolute neutrophil count (ANC) reaches1,500/mm^3, patients will start cycle 2. Patients will receive rituximab IV on day 1; cytarabine IV on day 1 and 2; ifosfamide IV, mesna IV, etoposide IV on day 1-5; and G-CSF SC daily beginning on day 7 and continuing until ANC is greater than 1,000 cells/mm^3.

Approximately 2-3 weeks later, patients receive another course of therapy as above.After cycle 4, patients in complete remission will take oral thalidomide until progression of disease. After completion of study treatment, patients are followed monthly for 3 months, every 3 months for 2 years, every 6 months for 3-5 years, and then annually thereafter or at study termination.

PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.

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.
  • 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 (SGOT and/or 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 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 HIV or AIDS
  • Presence of hepatitis or hepatitis B virus (HBV) infection
  • Pregnant or breast-feeding women.
  • Central nervous system (CNS) involvement

Treatment and study plan

Rituximab

Drug

Rituximab 375 mg/m2 IV, Days 1 of all cycles

Other names: Rituxan

Cyclophosphamide

Drug

Cyclophosphamide 800 mg/m2 IV, Day 1, Cyclophosphamide 200 mg/m2 IV Days 2 - 5, Cycles 1 and 3. Cyclophosphamide will be given in 100 cc NS IV over 30 minutes.

Other names: Cytoxan

Cytarabine

Drug

Cytarabine 2 grams/m2 IV every 12 hours x 4 doses, Days 1 and 2, Cycles 2 and 4.

Other names: AraC

Doxorubicin

Drug

Doxorubicin 45 mg/m2 IV bolus, Day 1, Cycles 1 and 3

Other names: Adriamycin

etoposide

Drug

Etoposide 60 mg/m2 IV daily x 5 days, Cycles 2 and 4

Other names: VP16

ifosfamide

Drug

Ifosfamide 1.5 grams/m2 IV once a day (QD) x 5 days, Cycles 2 and 4

Other names: Ifex

Leucovorin

Drug

Leucovorin 180 mg/m2 IV beginning 36 hours after start of methotrexate infusion and then 12 mg/m2 IV every 6 hours until methotrexate level is below 0.01 nM. Day 10, Cycles 1 and 3.

Other names: Folinic Acid

methotrexate

Drug

Methotrexate 1,200 mg/m2 in 250 cc 5 percent dextrose in water (D5W) IV over 1 hour followed by Methotrexate 5,520 mg/m2 in 1,000 cc D5W by continuous infusion over 23 hours (240 mg/m2 every hour for 23 hours). Day 10, Cycles 1 and 3.

Other names: amethopterin

thalidomide

Drug

Maintenance therapy.

Other names: Thalomid

Vincristine

Drug

Vincristine 1.5 mg/m2 IVP (maximum of 2 mg), Day 1 and 8 , Cycles 1 and 3.

Other names: Oncovin

Mesna

Drug

Mesna 360 mg/m2 IV every 3 hours x 5 days, Cycles 2 and 4

Other names: Mesnex

Filgrastim (G-CSF)

Drug

G-CSF 480 mcg subcutaneous (SQ) starting Day 13 (Cycles 1 and 3), Day 7 (Cycles 2 and 4)

Other names: Neupogen

Granisetron

Drug

Granisetron 1 mg IV on Day 1, Cycle 1 and 3

Other names: Sancuso, Granisol

Decadron

Drug

Decadron 10 mg IV on Day 1, Cycles 1 and 3

Other names: Maxidex, Ozurdex, Baycadron

Primary outcomes

  1. Progression-free Survival Rate

    Time frame: Up to 5 years

    Percentage of participants achieving progression-free survival at 1, 3 and 5 years after the start of protocol therapy, based upon the International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL). Progression is defined as a ≥ 50% increase from nadir in the product of the two largest perpendicular diameters (PPD-size) of any previously identified abnormal node, or appearance of any new lesion.

Secondary outcomes

  1. Overall Survival Rate

    Time frame: Up to 5 years

    Percentage of participants who are alive up to five years after receipt of protocol therapy.

  2. Response Rate

    Time frame: Up to 5 years

    Percentage of participants achieving complete response (CR) to protocol therapy according to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL) using the CT imaging method. Patients were classified by best tumor response; CR was defined as normalization of the lactate dehydrogenase (LDH), complete disappearance of disease-related symptoms and lymph nodes, and clearance of lymphoma from involved organs; complete response unconfirmed (CRu) as a residual lymph node greater than 1.5 cm in greatest transverse diameter that had regressed by more than 75% or an indeterminate bone marrow examination; partial response (PR) as greater than 50% reduction in the involved lymph nodes, or disappearance of the involved lymph nodes but persistent bone marrow involvement; relapse/progression as new or increased lymph nodes, organomegaly, or reappearance of bone marrow involvement.

  3. Number of Patients Experiencing Adverse Events.

    Time frame: Up to 5 years

    Number of patients experiencing adverse events during the course of protocol therapy.

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 (MACLO/IVAM) in Patients With Previously Untreated Mantle Cell Lymphoma

Important dates

Study start
2004
Primary completion
2015
Study completion
2015
First posted
Mar 22, 2007
Registry last updated
Nov 10, 2015

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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