Trial Outcomes & Findings for Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies (NCT NCT01678443)
NCT ID: NCT01678443
Last Updated: 2021-04-02
Results Overview
A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
2 participants
Primary outcome timeframe
Up to 30 days after receiving study drug
Results posted on
2021-04-02
Participant Flow
Participant milestones
| Measure |
Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies
Baseline characteristics by cohort
| Measure |
Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
n=2 Participants
Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant
|
|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 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
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after receiving study drugA DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.
Outcome measures
| Measure |
Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
n=2 Participants
Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant
|
|---|---|
|
Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsOutcome measures
| Measure |
Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
n=2 Participants
Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant
|
|---|---|
|
Overall Response Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsOutcome measures
| Measure |
Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
n=2 Participants
Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant
|
|---|---|
|
Overall Survival
|
750.5 days
Interval 243.0 to 1258.0
|
SECONDARY outcome
Timeframe: Up to 6 yearsOutcome measures
| Measure |
Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
n=2 Participants
Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant
|
|---|---|
|
Progression-free Survival
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: This outcome measure was not done. Only two patients were enrolled before the study was closed early. Tumor to normal organ ratios was not determined due to small sample size.
Derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of 90Y.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
n=2 participants at risk
Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
1/2 • Number of events 1 • AEs will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to the investigational product in this study (i.e., the start of the first dosimetry infusion) through day +30 post transplant or through discharge prior to that date from the SCCA system to care of the patient's primary physician
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 1 • AEs will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to the investigational product in this study (i.e., the start of the first dosimetry infusion) through day +30 post transplant or through discharge prior to that date from the SCCA system to care of the patient's primary physician
|
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