drugset / Trial / NCT00450801
R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2004-04
- Primary completion
- 2015-07
- Completion
- 2015-07
Publications
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 200 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 2 g | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 45 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Ifosfamide | Small molecule | 1.5 g | Intravenous |
| Subject | Methotrexate | Small molecule | 5520 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Thalidomide | Other / unclassified | 200 mg | Oral |
| Subject | Vincristine | Small molecule | 1.5 mg/m2 | Intravenous |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 360 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 10 mg | Intravenous |
| Background | Granisetron | Other / unclassified | 1 mg | Intravenous |
| Background | Leucovorin | Small molecule | 12 mg/m2 | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 480 ug | Subcutaneous |