Open label Multicenter Study of CVP Followed by Iodine-131 Anti-B1 Antibody for subjects with Untreated Low-Grade Non Hodgkin's Lymphoma.
Trial overview
Number of participants (par.) with unconfirmed response (Complete Response, Complete Response/Unconfirmed, or Partial Response), as assessed by the Investigator
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Number of participants (par.) with confirmed response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as assessed by the Investigator
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Number of participants with unconfirmed Complete Response (CR), as assessed by the Investigator
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Number of participants with confirmed Complete Response (CR), as assessed by the Investigator
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Duration of response (DOR), as assessed by the Investigator
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
DOR for unconfirmed and confirmed complete response, as assessed by the Investigator
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Time to progression of disease or death, as assessed by the Investigator
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Time to treatment failure, as assessed by the Investigator
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Total body residence time (TBRT; average amount of time TST spends in the body, calculated from the rate of TB clearance of radioactivity during the dosimetric dose [DD]) of Iodine 131 TST antibody following the DD
Timeframe: Day (D) 0; D 2, 3, or 4; and D 6 or 7
Time to nadir for hematological parameters: absolute neutrophil count (ANC), hemoglobin, platelets, and white blood cell (WBC) count
Timeframe: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)
Time to recovery (TTR) to baseline (BL) for hematologic laboratory (lab.) evaluations
Timeframe: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)
Nadir values for absolute neutrophil count (ANC)
Timeframe: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)
Nadir values for hemoglobin
Timeframe: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)
Nadir values for platelet count
Timeframe: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)
Nadir values for WBC count
Timeframe: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)
Number of participants with the indicated Grade 3 or Grade 4 Adverse Events (AEs)
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Number of participants with the indicated Grade 3 or Grade 4 AEs possibly or probably related to study drug
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Number of participants with any treatment-related serious adverse event (SAE)
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Number of participants with the indicated primary cause of death
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Number of participants who received any supportive care
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Number of participants who were negative for human anti-murine antibodies (HAMA) at Baseline (study entry) but positive or negative at Month 24
Timeframe: Day 1 to Day 730 (24 months) after receiving the dosimetric dose
Overall Survival
Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
- Subjects must have a histologically confirmed initial diagnosis of low-grade non-Hodgkin's B-cell lymphoma according to the International Working Formulation (IWF) (32) (i.e., small lymphocytic with or without plasmacytoid differentiation; follicular small cleaved cell; or follicular, mixed small cleaved and large cell).
- Subjects must have Ann Arbor Stage III, Stage IV, or bulky Stage II disease at diagnosis. Bulky Stage II is defined as a mediastinal mass greater than one-third of the maximum chest diameter, or any other mass greater than or equal to 10 cm in maximum diameter.
- Subjects who have received prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for their NHL.
- Subjects with active obstructive hydronephrosis.
- Subjects must have a histologically confirmed initial diagnosis of low-grade non-Hodgkin's B-cell lymphoma according to the International Working Formulation (IWF) (32) (i.e., small lymphocytic with or without plasmacytoid differentiation; follicular small cleaved cell; or follicular, mixed small cleaved and large cell).
- Subjects must have Ann Arbor Stage III, Stage IV, or bulky Stage II disease at diagnosis. Bulky Stage II is defined as a mediastinal mass greater than one-third of the maximum chest diameter, or any other mass greater than or equal to 10 cm in maximum diameter.
- Subjects must have evidence that their tumor tissue expresses the CD20 antigen. Immunoperoxidase stains of paraffin-embedded tissue showing positive reactivity with L26 antibody or immunoperoxidase stains of frozen tissue showing positive reactivity with Anti B1 Antibody (Coulter Clone®) or similar commercially available CD20 antibody or evidence of CD20 positivity by flow cytometry are acceptable evidence of CD20 positivity. Testing of tumor tissue from any time in the course of the patient's disease is acceptable.
- Subjects must have a performance status of at least 60% on the Karnofsky Performance Scale and an anticipated survival of at least 3 months.
- Subjects must have an ANC≥1500 cells/mm3 and a platelet count ≥100,000 cells/mm3 within 14 days of study enrollment. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
- Subjects must have adequate renal function (defined as serum creatinine <1.5 times the upper limit of normal) and hepatic function (defined as total bilirubin <1.5 times the upper limit of normal and AST <5 times the upper limit of normal) within 14 days of study enrollment.
- Subjects must have bi-dimensionally measurable disease. At least one lesion must be ≥2.0x2.0 cm by computerized tomography scan.
- Subjects must be at least 18 years of age.
- Subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment. -Subjects must give written informed consent and sign an IRB-approved informed consent form prior to study enrollment.
- Subjects who have received prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for their NHL. -Subjects with active obstructive hydronephrosis.
- Subjects with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation. -Subjects with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years. Patients who have been disease-free of another cancer for greater than 5 years must be carefully assessed at the time of study entry to rule out recurrent disease.
- Subjects with known HIV infection.
- Subjects who are HAMA positive.
- Subjects with known brain or leptomeningeal metastases.
- Subjects who are pregnant or breastfeeding. Males and females must agree to use a contraceptive method from enrollment to 6 months after receiving Iodine 131 Anti B1 Antibody.
- Subjects with active infection requiring IV anti-infectives at the time of study enrollment.
- Subjects with intermediate- or high-grade NHL.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.