Trial Outcomes & Findings for Open Label Multicenter Study of CVP Followed by Iodine-131 Anti-B1 Antibody for Subjects With Untreated Low-Grade Non Hodgkin's Lymphoma. (NCT NCT01663714)

Last Updated: 2017-01-11

Results Overview

Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Complete Response/unconfirmed (CRu: complete resolution of all disease-related symptoms; residual lymph node mass \>1.5 centimeters in the greatest transverse diameter that has regressed by \>75%, indeterminate bone marrow, are present), or Partial Response (PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome 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.

Results posted on

2017-01-11

Participant Flow

Participants (par.) received cyclophosphamide (C), vincristine (V), prednisone (P) in the first study phase (P). Upon completion of this P, par. began the first of 2 phases of radio immunotherapy: P1, dosimetric dose (DD); P2, therapeutic dose. Par. completing 2 years of the study could enter a long-term follow-up study (BEX104528; NCT00240578).

Participant milestones

Participant milestones
Measure	Chemotherapy; TST and Iodine I 131 TST Par. received 6 cycles of chemotherapy (chemo.): oral Cyclophosphamide (400 milligrams/meters squared \[mg/m\^2\]/day) for 1-5 days; intravenous (IV) Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Dosimetric and Therapeutic Treatment STARTED	30
Dosimetric and Therapeutic Treatment COMPLETED	0
Dosimetric and Therapeutic Treatment NOT COMPLETED	30
Long-Term Follow-Up STARTED	22
Long-Term Follow-Up COMPLETED	16
Long-Term Follow-Up NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemotherapy; TST and Iodine I 131 TST Par. received 6 cycles of chemotherapy (chemo.): oral Cyclophosphamide (400 milligrams/meters squared \[mg/m\^2\]/day) for 1-5 days; intravenous (IV) Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Dosimetric and Therapeutic Treatment Lost to Follow-up	3
Dosimetric and Therapeutic Treatment Progressive Disease	11
Dosimetric and Therapeutic Treatment Rolled Over to Study BEX104528	16
Long-Term Follow-Up Lost to Follow-up	1
Long-Term Follow-Up Death	4
Long-Term Follow-Up Non-compliance	1

Baseline Characteristics

Open Label Multicenter Study of CVP Followed by Iodine-131 Anti-B1 Antibody for Subjects With Untreated Low-Grade Non Hodgkin's Lymphoma.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Age, Continuous	50.6 Years STANDARD_DEVIATION 9.5 • n=5 Participants
Gender Female	17 Participants n=5 Participants
Gender Male	13 Participants n=5 Participants
Race/Ethnicity, Customized White	28 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 participants n=5 Participants

PRIMARY outcome

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.

Population: Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Number of Participants (Par.) With Unconfirmed Response (Complete Response, Complete Response/Unconfirmed, or Partial Response), as Assessed by the Investigator	30 participants

PRIMARY outcome

CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. CRu: complete resolution of all disease-related symptoms; residual lymph node mass \>1.5 centimeters in the greatest transverse diameter that has regressed by \>75%, indeterminate bone marrow, are present. PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Confirmed response required CR, CRu, or PR, which were confirmed by 2 separate response evaluations \>=4 weeks apart.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Number of Participants (Par.) With Confirmed Response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as Assessed by the Investigator	30 participants

SECONDARY outcome

Population: ITT Exposed Population

CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Number of Participants With Unconfirmed Complete Response (CR), as Assessed by the Investigator	21 participants

SECONDARY outcome

Population: ITT Exposed Population

CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy. Confirmed response required CR, which was confirmed by 2 separate response evaluations \>=4 weeks apart.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Number of Participants With Confirmed Complete Response (CR), as Assessed by the Investigator	21 participants

SECONDARY outcome

Population: ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.

DOR=the time from the first documented response (for par. with CR, CRu, or PR) until disease progression (DP). DP=a \>=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>1.5 centimeters (cm) in diameter by radiographic evaluation or \>1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=14 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Duration of Response (DOR), as Assessed by the Investigator Unconfirmed Responders	129.6 months Interval 42.1 to There were not enough events of progression to be able to determine/calculate the upper limit of the 95% confidence interval (CI).
Duration of Response (DOR), as Assessed by the Investigator Confirmed Responders	129.6 months Interval 42.1 to There were not enough events of progression to be able to determine/calculate the upper limit of the 95% CI.

SECONDARY outcome

Population: ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.

DOR=the time from the first documented response (for par. with CR) until disease progression (DP). DP=a \>=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>1.5 centimeters (cm) in diameter by radiographic evaluation or \>1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=7 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
DOR for Unconfirmed and Confirmed Complete Response, as Assessed by the Investigator Unconfirmed Responders with CR	129.6 months Interval 74.8 to There were not enough events of progression to be able to determine/calculate the upper limit of the 95% CI.
DOR for Unconfirmed and Confirmed Complete Response, as Assessed by the Investigator Confirmed Responders with CR	129.6 months Interval 74.8 to There were not enough events of progression to be able to determine/calculate the upper limit of the 95% CI.

SECONDARY outcome

Population: ITT Exposed Population. If a participant did not have progression or did not die, that participant was censored in the survival analysis.

Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a \>=50% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>1.5 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Time to Progression of Disease or Death, as Assessed by the Investigator	110.2 months Interval 38.3 to There were not enough events of progression to be able to determine/calculate the upper limit of the 95% CI.

SECONDARY outcome

Population: ITT Exposed Population. If a participant did not have treatment failure, that participant was censored in the survival analysis.

Time to treatment failure is defined as the time from the start of treatment to the first occurrence of study withdrawal, progression, or death.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Time to Treatment Failure, as Assessed by the Investigator	78.9 months Interval 36.5 to There were not enough events to be able to determine/calculate the upper limit of the 95% CI.

SECONDARY outcome

Timeframe: Day (D) 0; D 2, 3, or 4; and D 6 or 7

Population: ITT Exposed Population

To determine TBRT, the percent-injected activity (PIA) is calculated from the background-corrected (BC) total body count (TBC) at D 0; D 2/3/4; and D 7. The time from the DD to the acquisition of whole body count (WBC) is then determined. The PIA remaining at each time point (TP) is then calculated by dividing the BC WBC for that TP by the BC WBC from the first TP (D 0) \* 100. To determine RT, a best-fit line from 100% (pre-plotted D 0 value) through 2 plotted points (other TPs) is made. TBRT=the x-axis value at the point where the line intersects the horizontal 37% injected activity line.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
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	103.7 hours Standard Deviation 8.55

SECONDARY outcome

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)

Population: ITT Exposed Population

Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count ANC	49.0 days Interval 15.0 to 78.0
Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count Hemoglobin	49.0 days Interval 34.0 to 85.0
Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count Platelets	35.5 days Interval 26.0 to 56.0
Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count WBC count	44.0 days Interval 15.0 to 78.0

SECONDARY outcome

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)

Population: ITT Exposed Population. Only those participants with hematologic toxicity were evaluated for time to recovery to baseline.

TTR to BL grade (gr.) for par. with a Gr. 0 toxicity (tox.=lab. value outside the normal range) at BL=time from the last administration of study drug (SD) to the first post-nadir (PN) date with Gr. 0 toxicity with no other Gr. 1-4 toxicities recorded within the next week. For par. with a higher gr. tox. at BL, TTR=time from the last administration of SD to the first PN date with the BL gr. or better with no other higher gr. toxicities recorded during the next week. Each lab. established its own reference range using data from its own equipment/methods; there is no standard reference range.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations Time to recovery to baseline ANC, n=30	77.0 days Interval 70.0 to 91.0
Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations Time to recovery to baseline hemoglobin, n=28	76.5 days Interval 62.0 to 168.0
Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations Time to recovery to baseline platelets, n=30	60.5 days Interval 50.0 to 75.0
Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations Time to recovery to baseline WBC count, n=29	126.5 days Interval 75.0 to 170.0

SECONDARY outcome

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)

Population: ITT Exposed Population

Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Nadir Values for Absolute Neutrophil Count (ANC)	0.4 10^3 cells/cubic millimeters (mm^3) Interval 0.0 to 4.0

SECONDARY outcome

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)

Population: ITT Exposed Population

Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Nadir Values for Hemoglobin	10.6 Grams/deciliter (g/dL) Interval 6.0 to 15.0

SECONDARY outcome

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)

Population: ITT Exposed Population

Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Nadir Values for Platelet Count	57.0 10^3 cells/microliter (µL) Interval 4.0 to 145.0

SECONDARY outcome

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)

Population: ITT Exposed Population

Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Nadir Values for WBC Count	1.8 10^3 cells/µL Interval 0.0 to 5.0

SECONDARY outcome

Population: ITT Exposed Population

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Lymphopenia	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Alopecia	9 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Perirectal abscess	2 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Depression	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) ANC <1000 cells/mm^3	29 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) WBC <2000 cells/mm^3	23 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Platelets <50000 cells/mm^3	12 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Hemoglobin <8.0 g/dL	2 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Neutropenia	15 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Leukopenia	6 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Febrile neutropenia	5 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Thrombocytopenia	4 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Anemia	3 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Granulocytopenia	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Night sweats	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Acute myeloid leukaemia	2 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Basal cell carcinoma	2 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Myelodysplastic syndrome	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Prostate cancer	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Squamous cell carcinoma	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Urinary tract infection	2 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Cystitis	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Neutropenic infection	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Otitis media	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Periorbital cellulitis	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Aphasia	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Cerebrovascular accident	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Headache	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Hypoaesthesia	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) VIIth nerve paralysis	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Asthenia	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Pyrexia	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Myalgia	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Pain in extremity	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Insomnia	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Amenorrhoea	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Breast mass	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Conjunctivitis	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Constipation	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Drug hypersensitivity	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Aspartate aminotransferase increased	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Cystitis hemorrhagic	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Epistaxis	1 participants

SECONDARY outcome

Population: ITT Exposed Population

AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug ANC <1000 cells/mm^3	29 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug WBC <2000 cells/mm^3	23 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Platelets <50000 cells/mm^3	12 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Hemoglobin <8.0 g/dL	2 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Neutropenia	15 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Leukopenia	6 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Febrile neutropenia	5 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Thrombocytopenia	4 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Anemia	3 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Granulocytopenia	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Lymphopenia	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Alopecia	9 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Night sweats	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Perirectal abscess	2 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Urinary tract infection	2 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Cystitis	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Neutropenic infection	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Otitis media	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Periorbital cellulitis	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Acute myeloid leukaemia	2 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Basal cell carcinoma	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Myelodysplastic syndrome	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Squamous cell carcinoma	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Headache	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug VIIth nerve paralysis	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Depression	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Insomnia	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Conjunctivitis	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Constipation	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Pyrexia	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Aspartate aminotransferase increased	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Myalgia	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Cystitis hemorrhagic	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Amenorrhoea	1 participants
Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug Epistaxis	1 participants

SECONDARY outcome

Population: ITT-Exposed Population. All participants who experienced a treatment-related SAE were analyzed.

An SAE is defined as any event occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=11 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Febrile neutropenia	5 participants
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Anaemia	2 participants
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Neutropenia	2 participants
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Thrombocytopenia	2 participants
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Granulocytopenia	1 participants
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Leukopenia	1 participants
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Acute myeloid leukaemia	2 participants
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Basal cell carcinoma	1 participants
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Myelodysplastic syndrome	1 participants
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Squamous cell carcinoma	1 participants
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Perirectal abscess	2 participants
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Neutropenic infection	1 participants
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Pyrexia	1 participants
Number of Participants With Any Treatment-related Serious Adverse Event (SAE) Cystitis hemorrhagic	1 participants

SECONDARY outcome

Population: ITT Exposed Population. All participants who died during the study were analyzed.

The primary cause of death of the participants was assessed by the Investigator.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=9 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Number of Participants With the Indicated Primary Cause of Death Progression of lymphoma	5 participants
Number of Participants With the Indicated Primary Cause of Death Complications related to study drug	1 participants
Number of Participants With the Indicated Primary Cause of Death Other	3 participants

SECONDARY outcome

Population: ITT-Exposed Population

Supportive care is defined as interventions that help the participants achieve comfort but do not affect the course of a disease.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Number of Participants Who Received Any Supportive Care	17 participants

SECONDARY outcome

Timeframe: Day 1 to Day 730 (24 months) after receiving the dosimetric dose

Population: ITT Exposed Population

The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). To be "positive," a participant had to have a positive HAMA assessment during the first 24 months.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=30 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Month 24 Positive	0 participants
Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Month 24 Negative	30 participants

SECONDARY outcome

Population: ITT Exposed Population

Overall survival is defined as the time from the treatment start date to the date of death from any cause.

Outcome measures

Outcome measures
Measure	Chemotherapy; TST and Iodine I 131 TST n=9 Participants Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Overall Survival	NA months There were not enough events to be able to calculate the median or the confidence interval.

Adverse Events

Period After CVP

Serious events: 7 serious events

Other events: 30 other events

Deaths: 0 deaths

Period After Dosimetric and Therapeutic Dose

Serious events: 8 serious events

Other events: 30 other events

Deaths: 0 deaths

Combined Regimen Period

Serious events: 13 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Period After CVP n=30 participants at risk Par. received 6 cycles of chemotherapy as follows: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; intravenous Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days	Period After Dosimetric and Therapeutic Dose n=30 participants at risk After receiving Cyclophosphamide, Vincristine, and Prednisone, par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose.	Combined Regimen Period n=30 participants at risk Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m\^2/day) for 1-5 days; IV Vincristine (1.4 mg/m\^2) on Day 1; oral Prednisone (100 mg/m\^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) \>=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
Blood and lymphatic system disorders Febrile neutropenia	16.7% 5/30 • 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 both Study BEX104514 and Study BEX104528.	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	16.7% 5/30 • 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 both Study BEX104514 and Study BEX104528.
Blood and lymphatic system disorders Anemia	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	6.7% 2/30 • 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 both Study BEX104514 and Study BEX104528.	6.7% 2/30 • 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 both Study BEX104514 and Study BEX104528.
Blood and lymphatic system disorders Neutropenia	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.	6.7% 2/30 • 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 both Study BEX104514 and Study BEX104528.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	6.7% 2/30 • 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 both Study BEX104514 and Study BEX104528.	6.7% 2/30 • 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 both Study BEX104514 and Study BEX104528.
Blood and lymphatic system disorders Granulocytopenia	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.
Blood and lymphatic system disorders Leukopenia	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	6.7% 2/30 • 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 both Study BEX104514 and Study BEX104528.	6.7% 2/30 • 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 both Study BEX104514 and Study BEX104528.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	6.7% 2/30 • 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 both Study BEX104514 and Study BEX104528.	6.7% 2/30 • 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 both Study BEX104514 and Study BEX104528.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.
Infections and infestations Perirectal abscess	6.7% 2/30 • 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 both Study BEX104514 and Study BEX104528.	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	6.7% 2/30 • 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 both Study BEX104514 and Study BEX104528.
Infections and infestations Neutropenic infection	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.
General disorders Pyrexia	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.
Nervous system disorders Cerebrovascular accident	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.
Renal and urinary disorders Cystitis hemorrhagic	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.	0.00% 0/30 • 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 both Study BEX104514 and Study BEX104528.	3.3% 1/30 • 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 both Study BEX104514 and Study BEX104528.