Trial Outcomes & Findings for Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma (NCT NCT01468311)
NCT ID: NCT01468311
Last Updated: 2021-10-06
Results Overview
The MTD is defined as the dose level below the dose at which 2 out of 2 to 6 patients at a given dose level develop dose limiting toxicity (DLT). A DLT is defined as patients who develop either a Common Terminology Criteria in Adverse Events (CTCAE) v4.0 grade 3 or greater non-hematologic toxicity, with the exception of fatigue, of more than 5 days duration possibly, probably or definitely related to the infusion of 90Y-daclizumab prior to the start of BEAM chemotherapy (Day - 6) will have developed by definition a dose-limiting toxicity (DLT).
TERMINATED
PHASE1/PHASE2
6 participants
Day 100 post autologous stem cell transplant
2021-10-06
Participant Flow
Participant milestones
| Measure |
Yttrium-90-labeled Daclizumab + Chemotherapy
Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Yttrium-90-labeled Daclizumab + Chemotherapy
Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant
|
|---|---|
|
Overall Study
mobilization failure
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Yttrium-90-labeled Daclizumab + Chemotherapy
n=6 Participants
Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
29.05 years
STANDARD_DEVIATION 8.35 • n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Ethnicity, customized · Mexican, Puerto Rican, Cuban, Central or South Am.
|
2 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Ethnicity, customized · Not provided or available
|
2 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Ethnicity, customized · Not Hispanic
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Day 100 post autologous stem cell transplantPopulation: MTD was not determined due to low enrollment into the study.
The MTD is defined as the dose level below the dose at which 2 out of 2 to 6 patients at a given dose level develop dose limiting toxicity (DLT). A DLT is defined as patients who develop either a Common Terminology Criteria in Adverse Events (CTCAE) v4.0 grade 3 or greater non-hematologic toxicity, with the exception of fatigue, of more than 5 days duration possibly, probably or definitely related to the infusion of 90Y-daclizumab prior to the start of BEAM chemotherapy (Day - 6) will have developed by definition a dose-limiting toxicity (DLT).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 30 monthsHere is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Yttrium-90-labeled Daclizumab + Chemotherapy
n=6 Participants
Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant
|
|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
PRIMARY outcome
Timeframe: 30 monthsPatients who develop either a Common Terminology Criteria in Adverse Events (CTCAE) v4.0 grade 3 or greater non-hematologic toxicity, with the exception of fatigue, of more than 5 days duration possibly, probably or definitely related to the infusion of 90Y-daclizumab prior to the start of Carmustine, Etoposide, Cytarabine, \[Ara-C, Cytosine Arabinoside\] and Melphalan (BEAM) chemotherapy (Day - 6) will have developed by definition a dose-limiting toxicity (DLT).
Outcome measures
| Measure |
Yttrium-90-labeled Daclizumab + Chemotherapy
n=6 Participants
Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant
|
|---|---|
|
Number of Participants With A Dose Limiting Toxicity
|
0 Participants
|
SECONDARY outcome
Timeframe: Response is evaluated at day 100 post autologous stem cell transplant, then 1-4 times yearly for 5 yearsOverall response rate is defined as the number of complete and partial responses in patients with refractory or relapsed Hodgkin's disease. Response is assessed by the Revised Response Criteria for Malignant Lymphoma. Complete response requires all of the following: complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy. A post treatment residual mass is permitted as long as it is positron emission tomography negative. Partial response requires all of the following: at least a 50% reduction in the sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to all of the following: they should be clearly measurable in at least two perpendicular dimensions; if possible they should be from disparate regions of the body; and they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.
Outcome measures
| Measure |
Yttrium-90-labeled Daclizumab + Chemotherapy
n=4 Participants
Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant
|
|---|---|
|
Overall Response Rate
Complete Response (CR)
|
2 Participants
|
|
Overall Response Rate
Partial Response (PR)
|
2 Participants
|
SECONDARY outcome
Timeframe: 20 months post autologous stem cell transplantComplete response rate is defined as the time it takes a participant to achieve a complete response. Response is assessed by the Revised Response Criteria for Malignant Lymphoma. Complete response requires all of the following: complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy. A post treatment residual mass is permitted as long as it is positron emission tomography (PET) negative. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on computed tomography (CT) to normal size (\<1.5 cm in their greatest transverse diameter for nodes \>1.5 cm before therapy); Previously involved nodes that were 1.1 to 1.5 cm in their long axis and more than 1.0 cm in their short axis before treatment must have decreased to \<1.0 cm in their short axis after treatment.
Outcome measures
| Measure |
Yttrium-90-labeled Daclizumab + Chemotherapy
n=2 Participants
Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant
|
|---|---|
|
Complete Response Rate
|
7.5 months
Interval 6.0 to 9.0
|
SECONDARY outcome
Timeframe: DFS is evaluated at day 100 post autologous stem cell transplant, then 1-4 times yearly for 5 yearsDFS is defined as the amount of time participants remain disease free.
Outcome measures
| Measure |
Yttrium-90-labeled Daclizumab + Chemotherapy
n=4 Participants
Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant
|
|---|---|
|
Disease Free Survival (DFS)
|
36 months
Interval 30.0 to 42.0
|
SECONDARY outcome
Timeframe: OS is evaluated at day 100 post autologous stem cell transplant, then 1-4 times yearly for 5 yearsOverall survival is defined as the time from the date of registration to the date of death due to any cause or if no death occurs to the last documented information on the patient.
Outcome measures
| Measure |
Yttrium-90-labeled Daclizumab + Chemotherapy
n=4 Participants
Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant
|
|---|---|
|
Overall Survival
|
36 months
Interval 30.0 to 42.0
|
Adverse Events
Yttrium-90-labeled Daclizumab + Chemotherapy
Serious adverse events
| Measure |
Yttrium-90-labeled Daclizumab + Chemotherapy
n=6 participants at risk
Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant
|
|---|---|
|
Reproductive system and breast disorders
Menopause
|
16.7%
1/6 • Number of events 1 • 30 months
|
Other adverse events
| Measure |
Yttrium-90-labeled Daclizumab + Chemotherapy
n=6 participants at risk
Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Number of events 2 • 30 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 3 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • 30 months
|
|
General disorders
Fever
|
50.0%
3/6 • Number of events 6 • 30 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Infections and infestations
Infections and infestations - Other, strep mitis bacteremia
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Investigations
Lymphocyte count decreased
|
33.3%
2/6 • Number of events 3 • 30 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, Low zinc
|
33.3%
2/6 • Number of events 2 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Nervous system disorders
Nervous system disorders - Other, convulsive syncopal episode
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Oral pain
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 2 • 30 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Nervous system disorders
Seizure
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
2/6 • Number of events 2 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • 30 months
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • Number of events 1 • 30 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place