Last reviewed · How we verify
Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma
Phase 2 trial testing Etoposide, carboplatin, ifosfamide in Non-Hodgkin's Lymphoma in 96 participants. Completed in 12 March 2021.
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 96 |
| Start date | 1 July 2008 |
| Primary completion | 12 March 2021 |
| Estimated completion | 12 March 2021 |
| Sites | 1 location across United States |
Memorial Sloan Kettering Cancer Center — full company profile →
Adults 18 to 65, any sex, with Non-Hodgkin's Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
2-year PFS from the start of induction therapy conditional on attaining either a negative FDG-PET or a negative biopsy at the interim evaluation.
| Group | Value | 95% CI |
|---|---|---|
| Consolidation A | 86.6 | 78.4 – 95.7 |
| Consolidation B | 90.6 | 81.1 – 100.0 |
| Consolidation C | 0.4 | 0.2 – 0.5 |
Overall survival from the start of induction therapy conditional on attaining either a negative FDG-PET or a negative biopsy at the interim evaluation.
| Group | Value | 95% CI |
|---|---|---|
| Consolidation A | 98.3 | 95.1 – 100.0 |
| Consolidation B | 96.9 | 91.0 – 100.0 |
| Consolidation C | 50.0 | 18.8 – 100.0 |
Time frame: Up to 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Consolidation A | Consolidation B | Consolidation C |
|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Hemoglobin | Blood and lymphatic system disorders | — | — | — |
| Leukocytes | Investigations | — | — | — |
| Platelets | Investigations | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — |
| Fever (in the absence of neutropenia) | General disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Pain - Chest/thorax NOS | General disorders | — | — | — |
| Allerg react/hypersens (incl drug fever) | Immune system disorders | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — |
| Blood/Bone Marrow, other | Blood and lymphatic system disorders | — | — | — |
| Colitis | Gastrointestinal disorders | — | — | — |
| Confusion | Psychiatric disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Creatinine | Investigations | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Encephalopathy | Nervous system disorders | — | — | — |
| Enteritis | Gastrointestinal disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Neutrophils/granulocytes | Investigations | — | — | — |
| Pain - Anus | Gastrointestinal disorders | — | — | — |
| Pain - Back | Musculoskeletal and connective tissue disorders | — | — | — |
Most-reported serious reactions: Febrile neutropenia, Constipation, Hemoglobin, Leukocytes, Platelets, Diarrhea, Fever (in the absence of neutropenia), Nausea.
Data from ClinicalTrials.gov NCT00712582 adverse events section.
About 60% of patients with DLBCL can be cured with a chemotherapy program. It is called RCHOP-21 (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). It is given once every 3 weeks, for 18 weeks. Each three weeks is a cycle. Some factors predict that you may not be cured with R-CHOP-21. The most common ones are: * Stage - how much DLBCL, PMBL, or FL3B you have * LDH - a blood chemistry marker; and * Whether you can do your normal daily activities. (performance status) We think that the best way to cure more patients with poor risk factors is to add new treatment to R-CHOP. You will get different chemotherapy after 4 cycles. This type of treatment is called risk-adapted therapy.
5 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00712582.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing