Clinical trial · Interventional
S0213 Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma
Pilot Trial of Hyper-CVAD and Methotrexate/ARA C Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
NCT00041132CI-TRIAL-00008387completedPhase 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining rituximab with chemotherapy may kill more cancer cells. PURPOSE: Phase II pilot study to study the effectiveness of combining chemotherapy with rituximab in treating patients who have newly diagnosed 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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| leucovorin | Drug | Leucovorin | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyper-CVAD + MTX/Ara-C + Rituximab
- description
- 21-day cycles of Hyper-CVAD and high-dose methotrexate/cytarabine are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6. Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m\^2 on day 1, mesna 600 mg/m\^2 on days 2-4, cyclophosphamide 300 mg/m\^2 on days 2-4, doxorubicin 16.6 mg/m\^2/day on days 5-7, vincristine 1.4 mg/m\^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and filgrastim 5 ug/kg on days 8-21. Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m\^2 on day 1, methotrexate 1000 mg/m\^2 over days 2-3, Ara-C 12 g/m\^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21.
- interventionNames
- Biological: filgrastim
- Biological: rituximab
- Drug: cyclophosphamide
- Drug: cytarabine
- Drug: dexamethasone
- Drug: doxorubicin
- Drug: leucovorin
- Drug: methotrexate
- Drug: vincristine
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven stage III/IV or bulky stage II mantle cell lymphoma of one of the following histologic subtypes: * Nodular * Diffuse * Mantle zone * Blastic * Newly diagnosed and previously untreated disease * Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: * 18 to 69 Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 (50,000/mm\^3 if marrow involvement present) Hepatic: * Bilirubin no greater than 1.5 mg/dL (5.0 mg/dL if hepatic involvement present) Renal: * Creatinine no greater than 2.0 mg/dL * Creatinine clearance greater than 50 mL/min Cardiovascular: * Ejection fraction at least 50% by MUGA or 2-D echocardiogram * No significant abnormalities by EKG Other: * Not pregnant or nursing * Fertile patients must use effective contraception * Willing to receive blood product transfusions * No known sensitivity to E. coli-derived proteins * No known AIDS syndrome or HIV-associated complex * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior monoclonal antibody therapy Chemotherapy: * No prior chemotherapy for lymphoma Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for lymphoma Surgery: * Not specified
References
Publications (1)
- RESULTA multi center trial of hyperCVAD+rituxan in patients with newly diagnosed mantle cell lymphoma EM Epner; J Unger; T Miller; L Rimsza; C Spier; M LeBlanc; R Fisher. Blood 110(11):#387. (2007).