Phase 2
N=9
Phase 2 Study of Bexxar in Relapsed/Refractory DLCL
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00490009 ↗Enrolled (actual)
9
Serious AEs
100.0%
Results posted
Feb 2017
Primary outcome: Primary: Clinical Response Rate — 2; 0; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bexxar (Drug); Acetaminophen (Drug); Diphenhydramine (Drug); Potassium Iodide (KI) (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Susan Knox
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response Rate |
2; 0; 1; 1; 6; 1 | — |
| SECONDARY Time to Progression (TTP) |
1; 2; 2; 3 | — |
| SECONDARY Overall Survival (OS) Rate |
37.5 | — |
Summary
The purpose of this study is to obtain safety and efficacy data using Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).
Eligibility Criteria
Inclusion Criteria
- Histologically-confirmed, diffuse large cell lymphoma (DLCL), CD20+ B-cell non-Hodgkin lymphoma (NHL) who have relapsed after chemotherapy or are chemotherapy resistant, without prior history of low grade NHL. The patient must have failed at least one chemotherapy regimen containing an anthracycline or equivalent chemotherapeutic agent.
- No anticancer treatment for three weeks prior to the treatment dose of Bexxar (6 weeks if Rituximab, nitrosourea or Mitomycin C)
- Fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy
- An Institutional Review Board (IRB)-approved signed informed consent
- Age 19 years or older
- Prestudy Karnofsky Performance Status of ≥ 70%
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hct > 30%
- Hgb > 9.0 gm%
- Bilirubin ≤ 2.0
- Creatinine ≤ 2.0
- Bone marrow involvement with lymphoma less than 25% (bilateral bone marrow) within 6 weeks of enrollment
- Acceptable birth control method for men and women
- Female patients who are not pregnant
- Not lactating
Exclusion Criteria
- Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue
- Platelet count < 100,000/mm³
- Hypocellular bone marrow (≤ 15% cellularity)
- Marked reduction in bone marrow precursors of one or more cell lines
- History of failed stem cell collection
- Prior treatment with Fludarabine
- Prior radioimmunotherapy
- Presence of central nervous system (CNS) lymphoma
- Patients with known HIV or AIDS-related lymphoma
- Patients with evidence of myelodysplasia on bone marrow biopsy
- Patients who have received prior external beam radiation therapy to more than 25% of active bone marrow
- Patients who have received filgrastim or sargramostim therapy within 3 weeks prior to treatment
- Pregnant
- Lactating
- Presence of human anti-mouse antibody (HAMA) reactivity in patients with prior exposure to murine antibodies or proteins
- Serious nonmalignant disease or infection, which, in the opinion of the investigator, would compromise other protocol objectives
- Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with stable prostate specific antigen levels) for which the patients has not been disease-free for at least 3 years
- Major surgery, other than diagnostic surgery, within 4 weeks
- Patients with pleural effusion
Data sourced from ClinicalTrials.gov (NCT00490009). 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.