Trial Outcomes & Findings for Combination Veltuzumab and Fractionated 90Y- Epratuzumab Radioimmunotherapy in Follicular Lymphoma (NCT NCT01147393)
NCT ID: NCT01147393
Last Updated: 2018-02-22
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Results posted on
2018-02-22
Participant Flow
Participant milestones
| Measure |
All Subjects
two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.
90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over \~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.
veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2.
|
|---|---|
|
Dose Level 1
STARTED
|
3
|
|
Dose Level 1
COMPLETED
|
1
|
|
Dose Level 1
NOT COMPLETED
|
2
|
|
Dose Level -1
STARTED
|
1
|
|
Dose Level -1
COMPLETED
|
0
|
|
Dose Level -1
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Subjects
two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.
90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over \~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.
veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2.
|
|---|---|
|
Dose Level 1
Dose limiting Toxicity
|
2
|
|
Dose Level -1
Dose Limited Toxicity
|
1
|
Baseline Characteristics
Combination Veltuzumab and Fractionated 90Y- Epratuzumab Radioimmunotherapy in Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
All Subjects
n=4 Participants
two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.
90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over \~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.
veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2.
|
|---|---|
|
Age, Customized
Patients by Age · 60-69 Years of Age
|
3 Participants
n=5 Participants
|
|
Age, Customized
Patients by Age · 70-79 Years of Age
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Population: Data was not collected
Outcome measures
Outcome data not reported
PRIMARY outcome
Population: Data were not collected
NCI CTC version 3.0 is used to grade all adverse events and to provide management guidelines for infusional toxicity. Dose-limiting toxicity (DLT) is defined as follows: Hematologic: Grade 4 toxicity \>7 days, as specified by hemoglobin levels, platelet counts or absolute neutrophil count (ANC) or failure of hemoglobin levels, platelet counts or ANC to recover to Grade 1 levels within 12 weeks of completing the treatment cycle (with the use of RBC and platelet transfusions or growth factors during the 12 weeks if necessary, but at least one week without any support prior to qualifying Grade 1 levels). Non-Hematologic: Any Grade 3 or Grade 4. Other: Any Grade 2 autoimmune reactions, or the occurrence of Grade 2 immediate-type allergic/hypersensitivity reactions (e.g., urticaria, wheezing, hypoxia and dyspnea) will be considered DLT and will also require the infusion to be permanently terminated. Occurrence of DLT requires a patient's treatment to be permanently discontinued
Outcome measures
Outcome data not reported
PRIMARY outcome
Population: Data was not evaluated
Outcome measures
Outcome data not reported
PRIMARY outcome
Population: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Dose Level -1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose Level -1
n=1 participants at risk
veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 10 mCi/m2
|
Dose Level 1
n=3 participants at risk
veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 15 mCi/m2
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
1/1 • Number of events 3
|
100.0%
3/3 • Number of events 5
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
1/1 • Number of events 1
|
100.0%
3/3 • Number of events 5
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1
|
100.0%
3/3 • Number of events 5
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
1/1 • Number of events 2
|
33.3%
1/3 • Number of events 6
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hives (infusion reaction)
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Flutters (neck and throat)
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Taste alteration
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Easy bruisability
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Bleeding gums
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Nasal congestion
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Cough
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Epistaxis
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Dyspnea
|
100.0%
1/1 • Number of events 1
|
66.7%
2/3 • Number of events 3
|
|
General disorders
Insomnia
|
0.00%
0/1
|
100.0%
3/3 • Number of events 4
|
|
General disorders
Nausea
|
100.0%
1/1 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
|
General disorders
Sore throat
|
0.00%
0/1
|
66.7%
2/3 • Number of events 2
|
|
General disorders
Flatulence
|
0.00%
0/1
|
66.7%
2/3 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation (tongue)
|
0.00%
0/1
|
66.7%
2/3 • Number of events 2
|
|
General disorders
Visual changes (aura)
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Edema
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Pain (groin)
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Cyst (outer labia)
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritic rash (left shoulder,chest)
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Fall
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Pain (left unla, radial head fracture)
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Ear congestion
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Heartburn
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Diplopia
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Pain (joint)
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Neuropathy (numbness, tingling)
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Heat intolerance
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Cold intolerance
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Joint function (stiffness)
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Orthopnea
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation (hands, fingers)
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritic rash
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Muscle weakness (leg)
|
100.0%
1/1 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Dizziness
|
100.0%
1/1 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Constipation
|
100.0%
1/1 • Number of events 1
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place