Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma
NCT00006250CI-TRIAL-00012184unknownPhase 3ClinicalTrials.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. It is not yet known which combination chemotherapy regimen is more effective for non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have stage III or stage IV non-Hodgkin's 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chlorambucil | Drug | Chlorambucil | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Time to treatment failure
- measure
- Progression-free survival rate
- measure
- Overall survival rate
Secondary outcomes (2)
- measure
- Clinical remission rate
- measure
- Molecular remission rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma * REAL classification grade I, II, or III * Treatment necessity indicated by presence of the following: * B symptoms * Bone marrow failure * Bulky or progressive disease * Compression syndromes * No CNS involvement PATIENT CHARACTERISTICS: Age: * 18 to 70 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * No autoimmune hemolytic anemia or active hemolysis * Direct Coombs' negative Hepatic: * Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)\* * Bilirubin no greater than 2.5 times ULN\* NOTE: \*Unless attributable to lymphoma Renal: * Creatinine no greater than 2.5 times ULN (unless attributable to lymphoma) Cardiovascular: * No severe cardiac failure * Ejection fraction at least 45% Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for at least 6 months after study * HIV negative * No prior malignancy except carcinoma in situ of the cervix or squamous cell skin cancer * No other serious medical disease that would limit lifespan or ability to tolerate chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No concurrent systemic corticosteroids Radiotherapy: * Not specified Surgery: * Not specified Other: * No prior therapy
References
Publications (0)
Data not yet available
No reference posted for this study.