Clinical trial · Interventional
Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma
Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma
NCT00577629CI-TRIAL-00027840completedPhase 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 purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).
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, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| rituximab | Drug | Rituximab | ALIAS |
| tositumomab | Drug | Tositumomab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction + Consolidation + Bexxar
- description
- Induction:Cyclophosphamide, Etoposide, and Rituxan (rituximab) followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar (tositumomab)
- interventionNames
- Drug: cyclophosphamide
- Drug: etoposide
- Drug: rituximab
- Drug: cytarabine
- Drug: doxorubicin
- Drug: tositumomab
Primary outcomes (1)
- measure
- 1 Year Progression-free Survival Rate
- timeFrame
- 1 year
- description
- Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death. Definitions of response criteria are as described by Cheson. Progressive Disease: \>50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Untreated, biopsy proven B-cell non-Hodgkin's lymphoma * Age \>/= 18 years * No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for one year. The patient cannot have been exposed to chemotherapy to treat any of these diseases for at least 3 years prior to study entry. * Meet staging studies and laboratory tests prior to induction, consolidation and radioimmunotherapy. Exclusion Criteria: * Significant medical and/or psychiatric illness which may compromise planned treatment; * Pregnant or lactating; * HIV-infection. * Patients with follicular lymphoma grade 1, 2 or 3A are not eligible for this trial.
References
Publications (0)
Data not yet available
No reference posted for this study.