Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
Phase II CCOP Trial of High Dose Methotrexate/ARA-C and HCVAD for Newly Diagnosed Nodular and Diffuse Mantle Cell Lymphoma and Their Blastic Variants
NCT00003311CI-TRIAL-00035773completedPhase 2ClinicalTrials.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. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of different regimens of combination chemotherapy in treating patients with 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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regimen A
- description
- Methotrexate IV over 24 hours on day 1. Cytarabine is administered IV over 2 hours every 12 hours on days 2 and 3. Filgrastim (G-CSF) is administered subcutaneously (SC) daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for up to 8 courses.
- interventionNames
- Biological: filgrastim
- Drug: cytarabine
- Drug: methotrexate
- type
- EXPERIMENTAL
- label
- Regimen B
- description
- Cyclophosphamide IV over 3 hours every 12 hours on days 1-3. Doxorubicin is administered IV over 24 hours on days 4 and 5. Vincristine is administered IV over 30 minutes on days 4 and 11. Dexamethasone is administered orally or IV on days 1-4 and 11-14. G-CSF is administered SC beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for up to 7 courses.
- interventionNames
- Biological: filgrastim
- Drug: cyclophosphamide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed previously untreated nodular or diffuse mantle cell lymphoma or their blastic variant * No CNS involvement * Not a candidate for stem cell transplantation or refuses one PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3\* * Platelet count greater than 100,000/mm\^3\* NOTE: \* Unless lymphoma involvement Hepatic: * Bilirubin less than 1.5 mg/dL (unless lymphoma involvement) Renal: * Creatinine less than 2.0 mg/dL (unless lymphoma involvement) Cardiovascular: * Cardiac ejection fraction at least 50% (for patients over age 40) Other: * Must be willing to receive blood transfusion * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No other co-morbid medical or psychiatric illness that would preclude treatment * No prior or concurrent malignancy with poor prognosis (less than 90% probability of survival at 5 years) PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.