Trial Outcomes & Findings for Yttrium-90 Anti-CD45 Monoclonal Antibody BC8 Followed by Donor Stem Cell Transplant in Treating Patients With High-Risk AML, ALL, or MDS (NCT NCT01300572)

Last Updated: 2019-12-10

Results Overview

The MTD will be defined as the dose that is associated with a true DLT rate of 25%. The highest dose achieved was 28 Gy but none of the patients experienced a DLT. Thus, the MTD was not reached.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Within the first 30 days following transplant

Results posted on

2019-12-10

Participant Flow

This protocol is open to participants age 18 and above, of either gender and any race/ethnicity. The study is looking at the use of Y-90-DOTA-BC8 in conjunction with a standard reduced-intensity transplant regimen.

Participant milestones

Participant milestones
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or bone marrow transplant Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Indium In 111 Anti-CD45 Monoclonal Antibody BC8: Given IV (dosimetric dose)
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or bone marrow transplant Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Indium In 111 Anti-CD45 Monoclonal Antibody BC8: Given IV (dosimetric dose)
Overall Study HAMA + post dosimetry	1

Baseline Characteristics

Yttrium-90 Anti-CD45 Monoclonal Antibody BC8 Followed by Donor Stem Cell Transplant in Treating Patients With High-Risk AML, ALL, or MDS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) n=16 Participants Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with \~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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

PRIMARY outcome

Timeframe: Within the first 30 days following transplant

Population: Study participants who completed the study regimen.

The MTD will be defined as the dose that is associated with a true DLT rate of 25%. The highest dose achieved was 28 Gy but none of the patients experienced a DLT. Thus, the MTD was not reached.

Outcome measures

Outcome measures
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) n=15 Participants Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with \~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
The MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS.	28 Gy

SECONDARY outcome

Timeframe: 4 weeks after transplant

Population: Study participants who completed the study regimen

Number of participants who are in complete remission (CR) 4 weeks after transplant. CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following: 1. Normal bone marrow with blasts \<5% with normal cellularity, normal megakaryopoiesis, \> 15% erythropoiesis and \> 25% granulocytopoiesis 2. Normalization of blood counts (no blasts, platelets \> 100000/mm3, granulocytes \>1500/mm3) 3. No extramedullary disease.

Outcome measures

Outcome measures
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) n=15 Participants Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with \~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
Achievement of Remission	13 Participants

SECONDARY outcome

Timeframe: 100 days after transplant

Population: Study participants who completed study regimen and in CR after transplant.

Number of study participants who are alive and remains in complete remission after transplant.

Outcome measures

Outcome measures
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) n=15 Participants Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with \~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
Disease-free Survival	7 participants

SECONDARY outcome

Timeframe: 1 year

Population: Study participants who relapsed after achieving complete remission after transplant.

Median time to relapse after achieving complete remission (CR). CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following: 1. Normal bone marrow with blasts \<5% with normal cellularity, normal megakaryopoiesis, \> 15% erythropoiesis and \> 25% granulocytopoiesis 2. Normalization of blood counts (no blasts, platelets \> 100000/mm3, granulocytes \>1500/mm3) 3. No extramedullary disease. Relapse Criteria: 1. After CR: \>5% blasts in the bone marrow and/or peripheral blood 2. After partial remission (PR): increase of blasts cells in the marrow to \>50% of those during PR 3. Extramedullary disease confirmed cytologically or histologically.

Outcome measures

Outcome measures
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) n=13 Participants Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with \~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
Duration of Remission	213 days Interval 69.0 to 351.0

SECONDARY outcome

Timeframe: Approximately day -20 to day -12 prior to transplant

Population: All study participants who completed the study regimen.

The amount of energy absorbed per unit weight of the organ or tissue is called absorbed dose and is expressed in units of gray (Gy). One gray dose is equivalent to one joule radiation energy absorbed per kilogram of organ or tissue weight.

Outcome measures

Outcome measures
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) n=15 Participants Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with \~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor Average absorbed dose to the marrow	11.4 Gy Standard Deviation 9.2
Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor Average absorbed dose to the liver	17.2 Gy Standard Deviation 6.8
Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor Average abosorbed dose total body	3.1 Gy Standard Deviation 5.7
Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor Average absorbed dose to the spleen	70 Gy Standard Deviation 43

SECONDARY outcome

Timeframe: Up to 5 years

Number of participants who are still alive after transplant with or without disease.

Outcome measures

Outcome measures
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) n=15 Participants Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with \~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
Overall Survival	7 Participants

SECONDARY outcome

Timeframe: Up to 84 days post-transplant

Population: Overall number of participants analyzed is 14 because one patient died prior to d+84 after transplant.

Number of participants who developed acute GVHD post-transplant, aGVHD stages: Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Outcome measures

Outcome measures
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) n=14 Participants Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with \~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
Rates of Acute GvHD Grade 0 acute GVHD	4 Participants
Rates of Acute GvHD Grade I acute GVHD	1 Participants
Rates of Acute GvHD Grade II acute GVHD	6 Participants
Rates of Acute GvHD Grade III acute GVHD	2 Participants
Rates of Acute GvHD Grade IV acute GVHD	1 Participants

SECONDARY outcome

Timeframe: Up to 100 days post-transplant

Population: Overall number of participants analyzed is 14 because one patient died prior to d+84 after transplant.

Number of participants who has 100% donor chimerism within 100 days after transplant

Outcome measures

Outcome measures
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) n=14 Participants Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with \~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
Rates of Donor Chimerism	14 Participants

SECONDARY outcome

Timeframe: Up to 84 days post-transplant

Population: Study participants with an ANC \<= to 500 after transplant

Average number of days to ANC \>= 500 after transplant

Outcome measures

Outcome measures
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) n=14 Participants Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with \~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
Rates of Engraftment	16 days Standard Deviation 6.0

SECONDARY outcome

Timeframe: Within the first 100 days following transplant

Transplant-related deaths within 100 days after transplant

Outcome measures

Outcome measures
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) n=15 Participants Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with \~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
Rates of Non-relapse Mortality Severe refractory GVHD	1 Participants
Rates of Non-relapse Mortality Bacterial infection	1 Participants

Adverse Events

Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)

Serious events: 9 serious events

Other events: 11 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) n=15 participants at risk PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
Blood and lymphatic system disorders Febrile neutropenia	46.7% 7/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Gastrointestinal disorders Vomiting	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Investigations Creatinine increased	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Metabolism and nutrition disorders Anorexia	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Cardiac disorders Atrial fibrillation	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Gastrointestinal disorders Oral pain	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
General disorders Fever	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Infections and infestations Skin infection	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Metabolism and nutrition disorders Hypokalemia	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Musculoskeletal and connective tissue disorders Bone pain	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Nervous system disorders Headache	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Vascular disorders Hematoma	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Vascular disorders Hypertension	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.

Other adverse events

Other adverse events
Measure	Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) n=15 participants at risk PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
Blood and lymphatic system disorders Febrile neutropenia	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Cardiac disorders Chest pain - cardiac	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Cardiac disorders Heart failure	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Cardiac disorders Pericarditis	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Gastrointestinal disorders Abdominal pain	20.0% 3/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Gastrointestinal disorders Constipation	20.0% 3/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Gastrointestinal disorders Diarrhea	40.0% 6/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Gastrointestinal disorders Dry mouth	13.3% 2/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Gastrointestinal disorders Dyspepsia	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Gastrointestinal disorders Mucositis, oral	13.3% 2/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Gastrointestinal disorders Nausea	60.0% 9/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Gastrointestinal disorders Stomach pain	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Gastrointestinal disorders Vomiting	33.3% 5/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
General disorders Chills	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
General disorders Edema limbs	26.7% 4/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
General disorders Edema trunk	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
General disorders Fatigue	40.0% 6/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
General disorders Fever	13.3% 2/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Immune system disorders Allergic reaction	40.0% 6/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Infections and infestations Coag negative staph infection	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Infections and infestations CMV reactivation	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Infections and infestations Lung infection	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Infections and infestations Sepsis	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Infections and infestations Sinusitis	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Infections and infestations Upper respiratory infection - Rhinovirus	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Infections and infestations Upper respiratory infection - Rhinorrea	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Infections and infestations Upper respiratory infection - Metapneumovirus	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Investigations Blood bilirubin increased	20.0% 3/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Investigations Creatinine increased	13.3% 2/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Metabolism and nutrition disorders Anorexia	26.7% 4/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Metabolism and nutrition disorders Hyperglycemia	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Metabolism and nutrition disorders Hypokalemia	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Metabolism and nutrition disorders Hypomagnesemia	26.7% 4/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Metabolism and nutrition disorders Hyponatremia	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Musculoskeletal and connective tissue disorders Back pain	13.3% 2/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Musculoskeletal and connective tissue disorders Muscle weakness, lower limb	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Musculoskeletal and connective tissue disorders Muscle weakness, trunk	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 5/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Musculoskeletal and connective tissue disorders Neck pain	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Nervous system disorders Dizziness	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Nervous system disorders Dysgeusia	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Nervous system disorders Headache	26.7% 4/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Nervous system disorders Peripheral sensory neuropathy	13.3% 2/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Nervous system disorders Tremor	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Psychiatric disorders Depression	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Psychiatric disorders Hallucinations	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Psychiatric disorders Insomnia	13.3% 2/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Renal and urinary disorders Hematuria	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Renal and urinary disorders Urinary frequency	13.3% 2/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Renal and urinary disorders Urinary tract pain	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 3/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Respiratory, thoracic and mediastinal disorders Epistaxis	13.3% 2/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Respiratory, thoracic and mediastinal disorders Hypoxia	13.3% 2/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Respiratory, thoracic and mediastinal disorders Postnasal drip	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Respiratory, thoracic and mediastinal disorders Sinus disorder	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Respiratory, thoracic and mediastinal disorders Sore throat	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Skin and subcutaneous tissue disorders Pruritis	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Skin and subcutaneous tissue disorders Rash acneiform	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Skin and subcutaneous tissue disorders Rash maculo-papular	40.0% 6/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Vascular disorders Hematoma	6.7% 1/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Vascular disorders Hypertension	13.3% 2/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
Vascular disorders Hypotension	13.3% 2/15 • Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician. Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.

Additional Information

Brenda Sandmaier, MD

Fred Hutchinson Cancer Research Center

Phone: (206) 667-4961

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place