Phase 2
Completed N=39
Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma
Source: ClinicalTrials.gov NCT00577629 ↗Enrolled (actual)
39
Serious AEs
71.8%
Results posted
Apr 2013
Primary outcomePrimary: 1 Year Progression-free Survival Rate — 0.74 percentage of participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1 Year Progression-free Survival Rate |
0.74 | — |
| SECONDARY Disease-free Survival |
54.10 | — |
| SECONDARY Overall Survival |
82 | — |
| SECONDARY Overall Response |
92 | — |
| SECONDARY Secondary Malignancies |
3; 1; 1; 1; 1; 1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00577629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.