Clinical trial · Interventional
Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
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
NCT00878254CI-TRIAL-00092475completedPhase 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)
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).
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 |
|---|---|---|---|
| Mantle-Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| G-CSF | Biological | — | UNRESOLVED |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Mesna | Drug | — | UNRESOLVED |
| Methotrexate | Drug |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-MACLO/IVAM Group
- description
- Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows: Induction Therapy: * Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin and Granulocyte-colony stimulating factor (G-CSF) * Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF. Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years. Total participation duration is about 4 years. Participants will be followed for survival.
- interventionNames
- Biological: G-CSF
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Doxorubicin
- Drug: Etoposide
- Drug: Ifosfamide
- Drug: Leucovorin
- Drug: Mesna
- Drug: Methotrexate
- Drug: Vincristine
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Previously untreated, histologically confirmed mantle cell lymphoma, 2. Measurable or evaluable disease (at least one site with \>1.5 cm in diameter 3. All stages are eligible 4. Age \> 18 years 5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 6. 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 7. Serum creatinine\< 1.5 mg/dl 8. Ability to give informed consent 9. 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. 10. Life expectancy greater than 6 months. Exclusion Criteria: 1. Previous chemotherapy, immunotherapy or radiotherapy for this mantle cell lymphoma 2. Concurrent active malignancies, with the exception of in situ carcinoma of the cervix and basal cell carcinoma of the skin. 3. Grade 3 or 4 cardiac failure and/or ejection fraction \< 50. 4. Psychological, familial, sociological or geographical conditions that do not permit treatment and/or medical follow-up required to comply with the study protocol. 5. Patients with a known history of human immunodeficiency virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS). 6. Presence of hepatitis or hepatitis B virus (HBV) infection. 7. Pregnant or breast-feeding women. 8. Central Nervous System (CNS) involvement.
References
Publications (1)
- RESULTAlderuccio 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