Clinical trial · Interventional
R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma
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
NCT00450801CI-TRIAL-00019740completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Decadron | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Filgrastim (G-CSF) | Drug | Filgrastim | ALIAS |
| Granisetron | Drug | — | UNRESOLVED |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Leucovorin |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-MACLO-IVAM-T
- description
- 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.
- interventionNames
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Doxorubicin
- Drug: Etoposide
- Drug: Ifosfamide
- Drug: Leucovorin
- Drug: Methotrexate
- Drug: Thalidomide
- Drug: Vincristine
- Drug: Mesna
- Drug: Filgrastim (G-CSF)
- Drug: Granisetron
- Drug: Decadron
Primary outcomes (1)
- measure
- Progression-free Survival Rate
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTLossos 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. PMID 20038221
- DERIVEDAlderuccio 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. PMID 33735476