Clinical trial NCT00268203: Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma
Official title: Expanded Access Study of Iodine I 131 Tositumomab for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Keywords: expanded access study
refractory low-grade non-Hodgkin's Lymphoma
Bexxar®
Iodine I 131 Tositumomab
EAP
relapsed low-grade non-Hodgkin's lymphoma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-22
Enrollment: 765
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine I 131 Tositumomab more broadly available to patients. Secondary endpoints will be to obtain additional safety and efficacy information for this treatment regimen. Post study drug administration follow-ups will continue for up to ten years. These will include blood-work and adverse event assessments for 13 weeks post dosing, patient response evaluations at Week 13, Months 6, 12, 18, 24, and Long-Term Follow-ups every 6 months until the elapse of 5 years from the dosimetric dose and then annually thereafter through year 10. Thyroid function will be monitored annually during Long-term follow-up.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of low- grade NHL or transformed low-grade NHL (tumor must be CD 20 positive).
* Prior treatment with at least one chemotherapy regimen and have relapsed or progressed, or failed to achieve an objective response on last chemotherapy regimen.
* Karnofsky performance status of at least 60% and anticipated survival of at least 3 months.
* Absolute granulocyte of \>/= 1,500/mm3.
* Platelet count of \>/= 100,000/mm3, and not require sustained support of hematopoietic cytokines, or transfusion of blood products.
* Adequate renal function (i.e., \<1.5x Upper Limit of Normal), and hepatic transaminases (AST \<5 times ULN).
* Signed IRB/IEC-approved informed consent.

Exclusion Criteria:

* Patients with a mean of \>25% of the intratrabecular marrow space involved with lymphoma.
* Patients who received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosurea compounds) or who exhibit persistent clinical evidence of toxicity.
* Patients who have undergone stem cell or bone marrow transplant, active obstructive hydronephrosis, active infection, New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.
* Known HIV infection.
* Pregnant or nursing patients.
* Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer, in-situ cervical cancer, or cancer for which the patient has been disease-free for 5 years.
* Patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with more than 3500 cGy.
* Patients who received prior radioimmunotherapy, known brain or leptomeningeal metastases, HAMA positivity.
* Patients who are receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.

Primary outcomes:
measure: Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response
timeFrame: From randomization until the first documented complete response or partial response (up to 161 months)
measure: Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response
timeFrame: From randomization until the first documented complete response or partial response (up to 161 months)
measure: Duration of Response for Participants With Unconfirmed Response (CR+PR)
timeFrame: From the time of the first documented response (CR or PR) until disease progression (up to 161 months)
measure: Duration of Response for Participants With Confirmed Response (CR+PR)
timeFrame: From the time of the first documented response (CR or PR) until disease progression (up to 161 months)
measure: Duration of Response (DOR) in Unconfirmed Complete Responders
timeFrame: From the time of the first documented unconfirmed CR until PD (up to 161 months)
measure: Duration of Response (DOR) in Confirmed Complete Responders
timeFrame: From the time of the first documented CR until PD (up to 161 months)
measure: Time to Progression or Death
timeFrame: From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months)
Secondary outcomes:
measure: Time to Treatment Failure
timeFrame: From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: