R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma
NCT ID: NCT00450801
Last Updated: 2015-11-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2004-04-30
2015-07-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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R-MACLO-IVAM-T
Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
Rituximab
Rituximab 375 mg/m2 IV, Days 1 of all cycles
Cyclophosphamide
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.
Cytarabine
Cytarabine 2 grams/m2 IV every 12 hours x 4 doses, Days 1 and 2, Cycles 2 and 4.
Doxorubicin
Doxorubicin 45 mg/m2 IV bolus, Day 1, Cycles 1 and 3
Etoposide
Etoposide 60 mg/m2 IV daily x 5 days, Cycles 2 and 4
Ifosfamide
Ifosfamide 1.5 grams/m2 IV once a day (QD) x 5 days, Cycles 2 and 4
Leucovorin
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.
Methotrexate
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.
Thalidomide
Maintenance therapy.
Vincristine
Vincristine 1.5 mg/m2 IVP (maximum of 2 mg), Day 1 and 8 , Cycles 1 and 3.
Mesna
Mesna 360 mg/m2 IV every 3 hours x 5 days, Cycles 2 and 4
Filgrastim (G-CSF)
G-CSF 480 mcg subcutaneous (SQ) starting Day 13 (Cycles 1 and 3), Day 7 (Cycles 2 and 4)
Granisetron
Granisetron 1 mg IV on Day 1, Cycle 1 and 3
Decadron
Decadron 10 mg IV on Day 1, Cycles 1 and 3
Interventions
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Rituximab
Rituximab 375 mg/m2 IV, Days 1 of all cycles
Cyclophosphamide
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.
Cytarabine
Cytarabine 2 grams/m2 IV every 12 hours x 4 doses, Days 1 and 2, Cycles 2 and 4.
Doxorubicin
Doxorubicin 45 mg/m2 IV bolus, Day 1, Cycles 1 and 3
Etoposide
Etoposide 60 mg/m2 IV daily x 5 days, Cycles 2 and 4
Ifosfamide
Ifosfamide 1.5 grams/m2 IV once a day (QD) x 5 days, Cycles 2 and 4
Leucovorin
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.
Methotrexate
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.
Thalidomide
Maintenance therapy.
Vincristine
Vincristine 1.5 mg/m2 IVP (maximum of 2 mg), Day 1 and 8 , Cycles 1 and 3.
Mesna
Mesna 360 mg/m2 IV every 3 hours x 5 days, Cycles 2 and 4
Filgrastim (G-CSF)
G-CSF 480 mcg subcutaneous (SQ) starting Day 13 (Cycles 1 and 3), Day 7 (Cycles 2 and 4)
Granisetron
Granisetron 1 mg IV on Day 1, Cycle 1 and 3
Decadron
Decadron 10 mg IV on Day 1, Cycles 1 and 3
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Izidore Lossos
Professor
Principal Investigators
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Izidore S. Lossos, MD
Role: STUDY_CHAIR
University of Miami Sylvester Comprehensive Cancer Center
Locations
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University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States
Countries
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References
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Lossos IS, Hosein PJ, Morgensztern D, Coleman F, Escalon MP, Byrne GE Jr, Rosenblatt JD, Walker GR. High rate and prolonged duration of complete remissions induced by rituximab, methotrexate, doxorubicin, cyclophosphamide, vincristine, ifosfamide, etoposide, cytarabine, and thalidomide (R-MACLO-IVAM-T), a modification of the National Cancer Institute 89-C-41 regimen, in patients with newly diagnosed mantle cell lymphoma. Leuk Lymphoma. 2010 Mar;51(3):406-14. doi: 10.3109/10428190903518345.
Alderuccio JP, Saul EE, Iyer SG, Reis IM, Alencar AJ, Rosenblatt JD, Lossos IS. R-MACLO-IVAM regimen followed by maintenance therapy induces durable remissions in untreated mantle cell lymphoma - Long term follow up results. Am J Hematol. 2021 Jun 1;96(6):680-689. doi: 10.1002/ajh.26163. Epub 2021 Apr 7.
Other Identifiers
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SCCC-2003027
Identifier Type: OTHER
Identifier Source: secondary_id
WIRB-20051242
Identifier Type: OTHER
Identifier Source: secondary_id
20030165
Identifier Type: -
Identifier Source: org_study_id
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