Trial Outcomes & Findings for Iodine I 131 Monoclonal Antibody BC8 Before Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma (NCT NCT00860171)

Results Overview

Dose escalation/de-escalation will be conducted by the "two-stage" approach introduced by Storer. Escalation will continue until a dose-limiting toxicity (DLT) occurs. A DLT will be defined as a therapy-related grade III or IV Bearman (transplant) toxicity. The MTD is estimated to be the dose that is associated with a toxicity rate of 25% (Bearman grade 3-4).

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Within 30 days post-transplant

Results posted on

2020-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT) Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0. Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter Iodine I 131 Monoclonal Antibody BC8: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Iodine I 131 Monoclonal Antibody BC8 Before Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT) n=16 Participants Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0. Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter Iodine I 131 Monoclonal Antibody BC8: Given IV Laboratory Biomarker Analysis: Correlative studies
Age, Continuous	56.81 years STANDARD_DEVIATION 15.63 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 days post-transplant

Dose escalation/de-escalation will be conducted by the "two-stage" approach introduced by Storer. Escalation will continue until a dose-limiting toxicity (DLT) occurs. A DLT will be defined as a therapy-related grade III or IV Bearman (transplant) toxicity. The MTD is estimated to be the dose that is associated with a toxicity rate of 25% (Bearman grade 3-4).

Outcome measures

Outcome measures
Measure	Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT) n=16 Participants Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0. Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter Iodine I 131 Monoclonal Antibody BC8: Given IV Laboratory Biomarker Analysis: Correlative studies
Maximum Tolerated Dose (MTD) of I-131-BC8 That Can be Delivered Prior to Transplant	NA Gray of I-131 (absorbed dose that the I No dose-limiting toxicities observed. Funding ran out, and no MTD identified by the time last patient treated.

PRIMARY outcome

Timeframe: At time of I-131 therapy

Outcome measures

Outcome measures
Measure	Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT) n=16 Participants Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0. Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter Iodine I 131 Monoclonal Antibody BC8: Given IV Laboratory Biomarker Analysis: Correlative studies
I-131 Activity Administered	668.15 mCi I-131 Interval 344.0 to 1064.0

SECONDARY outcome

Timeframe: Up to 6 years

Descriptive statistics will be calculated. DLT will be defined by the Bearman Scale that is designed to address the specific toxicities associated with transplantation.

Outcome measures

Outcome measures
Measure	Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT) n=16 Participants Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0. Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter Iodine I 131 Monoclonal Antibody BC8: Given IV Laboratory Biomarker Analysis: Correlative studies
Adverse Events	0 number of adverse events

SECONDARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome measures
Measure	Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT) n=16 Participants Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0. Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter Iodine I 131 Monoclonal Antibody BC8: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Survival	1057 days Standard Deviation 633.59

SECONDARY outcome

Timeframe: Up to 6 years

number of people with progression free survival

Outcome measures

Outcome measures
Measure	Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT) n=16 Participants Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0. Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter Iodine I 131 Monoclonal Antibody BC8: Given IV Laboratory Biomarker Analysis: Correlative studies
Progression-free Survival	5 Participants

SECONDARY outcome

Timeframe: Up to 6 years

Number of relapse

Outcome measures

Outcome measures
Measure	Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT) n=16 Participants Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0. Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter Iodine I 131 Monoclonal Antibody BC8: Given IV Laboratory Biomarker Analysis: Correlative studies
Relapse Rate	5 Participants

Adverse Events

Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT) n=16 participants at risk Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0. Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter Iodine I 131 Monoclonal Antibody BC8: Given IV Laboratory Biomarker Analysis: Correlative studies
General disorders Fever	6.2% 1/16 • Number of events 1
Gastrointestinal disorders Mucositis/stomatitis	6.2% 1/16 • Number of events 1
Respiratory, thoracic and mediastinal disorders dyspnea	6.2% 1/16 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Ajay K. Gopal, MD

Fred Hutchinson Cancer Research Center

Phone: 206-288-2037

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place