Phase 2 N=39 Treatment

Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

Lymphoma, B-Cell

Bottom Line

View on ClinicalTrials.gov: NCT00577629 ↗

Enrolled (actual)

Serious AEs

71.8%

Results posted

Apr 2013

Primary outcome: Primary: 1 Year Progression-free Survival Rate — 0.74 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: cyclophosphamide (Drug); etoposide (Drug); rituximab (Drug); cytarabine (Drug); doxorubicin (Drug); tositumomab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Apr 2012

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	—

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).

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.

View full record on ClinicalTrials.gov →

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.