Phase 2 Study of Bexxar in Relapsed/Refractory DLCL

Susan Knox9 enrolled

Overview

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).

There is a lack of efficacious treatment options for patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL) who are not appropriate candidates for stem cell transplantation. DLCL is a relatively radiosensitive disease and patients with DLCL have been reported to respond to anti-CD20 monoclonal antibody (MAB) therapy. Therefore, radioimmunotherapy targeting CD20 is a rational and promising therapeutic approach for this patient population. This study evaluated if Bexxar is safe and efficacious for diffuse large cell Non-Hodgkin's lymphoma.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma

Interventions

BexxarDRUG

Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. The radioactive isotope then gives off radiation, which kills the cells. Bexxar will be administered to provide the following patient-specific radiotherapy: * Platelet count of 150,000/mm³ = 75 cGy * Platelet count ≥ 100,000/mm³ but \< 150,000/mm³ = 65 cGy

AcetaminophenDRUG

As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain

DiphenhydramineDRUG

As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

Clinical Response Rate

Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response.

Time frame: 6 years

Secondary Outcomes

Time to Progression (TTP)

Time of disease progression reported as the number of subjects experiencing disease progression at the time point of progression.

Time frame: 1.5 months; 3 months; 6 months; or Not Progressed

Overall Survival (OS) Rate

Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years.

Time frame: 6 years

Data from ClinicalTrials.gov

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