Phase 2
N=15
Iodine-131 Anti-B1 Antibody Consolidation for Patients With Non-Hodgkin's Lymphoma Following First-line CHOP
Lymphoma, Non-Hodgkin
Bottom Line
View on ClinicalTrials.gov: NCT01868035 ↗Enrolled (actual)
15
Serious AEs
20.0%
Results posted
Sep 2013
Primary outcome: Primary: Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody — 1; 1; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- tositumomab and iodine I-131 tositumomab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody |
1; 1; 1; 1 | — |
| SECONDARY Number of Participants (Par.) With Confirmed (Con.) Complete Response (CR) Confirmed, Confirmed Complete Response Unconfirmed (CRu), Confirmed Partial Response (PR), Relapse Disease (RD), and Progressive Disease (PD) |
12; 0; 13; 1; 0; 0 | — |
| SECONDARY Duration of Response and Duration of Confirmed Complete Response |
58.4; 58.4 | — |
| SECONDARY Progression-free Survival (PFS) |
63.0 | — |
| SECONDARY Time to Treatment Failure (TTF) |
63.0 | — |
| SECONDARY Total Body Residence Time (TBRT) |
105.5 | — |
| SECONDARY Number of Participants With an Adverse Experience, Including Adverse Events (AEs) and Serious Adverse Events (SAEs) |
14; 3 | — |
| SECONDARY Time to Recovery From the Indicated Hematology Toxicities |
78.5; 69.0; 51.0; 77.0 | — |
| SECONDARY Nadir for the Indicated Hematology Toxicities |
1.1; 10.5; 89.9; 2.2 | — |
| SECONDARY Time to Nadir for the Indicated Hematology Toxicities |
55.0; 49.5; 35.5; 52.7 | — |
| SECONDARY Number of Participants Needing Supportive Care at Week 7 and Week 13 |
3; 3 | — |
| SECONDARY Number of Participants Converting to Human Anti-Murine (Mouse) Antibody (HAMA) Positivity at Any Follow-up Visit From HAMA Negativity at Baseline |
1; 14 | — |
| SECONDARY Overall Survival |
NA | — |
Summary
This is a multicenter study for the long-term follow-up of surviving patients who are expected to complete or who have completed at least two years of follow-up after treatment with Iodine I 131 Tositumomab (BEXXAR) on studies CP-97-011, CP-98-025, CP-99-032, or CP-99-036. All patients will be assessed for survival and disease status, including subsequent therapy for Diffuse Large B-cell Non-Hodgkin's Lymphoma (NHL), and for long-term safety. Additionally laboratory evaluations consisting of a thyroid stimulating hormone (TSH) level and a complete blood cell (CBC) count with a differential and platelet count will be obtained annually. Additionally, patients who remain in long-term response following Iodine I 131 Tositumomab treatment will be followed for response and progression.
Eligibility Criteria
Inclusion Criteria
- male or female subjects age 18 to 80 years, inclusive, with any International Prognostic Index score; treated with 6 or more cycles of first-line CHOP chemotherapy and achieved a PR, CRu, or CR
- de novo diffuse large B-cell NHL according to the REAL classification; Ann Arbor stage III, stage IV, or bulky stage II disease (any mass ≥10 cm in diameter)
- less than an average of 25% of the intratrabecular marrow space involved by NHL in bilateral bone marrow biopsy specimens or 5 years)
- human immunodeficiency virus infection
- HAMA positive
- brain or leptomeningeal metastases at any time since diagnosis
- active infection requiring intravenous anti-infectives
- pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT01868035). 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.