Trial Outcomes & Findings for Rituximab, Yttrium Y 90 Ibritumomab Tiuxetan in Patients W/Relapsed Stage II, III, or IV Follicular NHL (NCT NCT00732498)
NCT ID: NCT00732498
Last Updated: 2019-09-04
Results Overview
To evaluate the 1-year progression-free survival (PFS) of patients with relapsed follicular non-Hodgkin's lymphoma (NHL) treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
1 year
Results posted on
2019-09-04
Participant Flow
Participant milestones
| Measure |
ESHAP Followed by Zevalin and Rituximab
Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.
Methylprednisolone: 250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Etoposide: 40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cytarabine: 2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cisplatin: 25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be admin
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
ESHAP Followed by Zevalin and Rituximab
Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.
Methylprednisolone: 250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Etoposide: 40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cytarabine: 2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cisplatin: 25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be admin
|
|---|---|
|
Overall Study
Ineligible
|
1
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
Rituximab, Yttrium Y 90 Ibritumomab Tiuxetan in Patients W/Relapsed Stage II, III, or IV Follicular NHL
Baseline characteristics by cohort
| Measure |
ESHAP Followed by Zevalin and Rituximab
n=28 Participants
Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.
Methylprednisolone: 250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Etoposide: 40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cytarabine: 2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cisplatin: 25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be admin
|
|---|---|
|
Age, Customized
Median age, years
|
61 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
|
Baseline B Symptoms
|
15 Participants
n=5 Participants
|
|
Bone marrow involvement
|
12 Participants
n=5 Participants
|
|
Prior transplant history
|
1 Participants
n=5 Participants
|
|
Tumor bulk >5cm
|
7 Participants
n=5 Participants
|
|
Prior chemotherapy regimens
Zero cycles
|
0 Participants
n=5 Participants
|
|
Prior chemotherapy regimens
One cycle
|
16 Participants
n=5 Participants
|
|
Prior chemotherapy regimens
Two cycles
|
7 Participants
n=5 Participants
|
|
Prior chemotherapy regimens
Three cycles
|
3 Participants
n=5 Participants
|
|
Prior chemotherapy regimens
Four cycles
|
2 Participants
n=5 Participants
|
|
Elevated beta2-microglobin
|
11 Participants
n=5 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI)
0
|
1 Participants
n=5 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI)
1
|
4 Participants
n=5 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI)
2
|
10 Participants
n=5 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI)
3
|
8 Participants
n=5 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI)
4
|
5 Participants
n=5 Participants
|
|
The Follicular Lymphoma International Prognostic Index-2 (FLIPI2)
0
|
4 Participants
n=5 Participants
|
|
The Follicular Lymphoma International Prognostic Index-2 (FLIPI2)
1
|
9 Participants
n=5 Participants
|
|
The Follicular Lymphoma International Prognostic Index-2 (FLIPI2)
2
|
8 Participants
n=5 Participants
|
|
The Follicular Lymphoma International Prognostic Index-2 (FLIPI2)
3
|
5 Participants
n=5 Participants
|
|
The Follicular Lymphoma International Prognostic Index-2 (FLIPI2)
4
|
2 Participants
n=5 Participants
|
|
Response to prior chemotherapy regimens
Complete reponse
|
9 Participants
n=5 Participants
|
|
Response to prior chemotherapy regimens
Partial response
|
4 Participants
n=5 Participants
|
|
Response to prior chemotherapy regimens
Stable disease
|
1 Participants
n=5 Participants
|
|
Response to prior chemotherapy regimens
Progressive disease
|
11 Participants
n=5 Participants
|
|
Response to prior chemotherapy regimens
Unknown
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearTo evaluate the 1-year progression-free survival (PFS) of patients with relapsed follicular non-Hodgkin's lymphoma (NHL) treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy.
Outcome measures
| Measure |
ESHAP Followed by Zevalin and Rituximab
n=22 Participants
Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.
Methylprednisolone: 250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Etoposide: 40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cytarabine: 2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cisplatin: 25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be admin
|
|---|---|
|
Progression-free Survival at 1 Year
|
38 percentage of participants
|
PRIMARY outcome
Timeframe: 5 yearsTo evaluate the median TTP of patients with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy.
Outcome measures
| Measure |
ESHAP Followed by Zevalin and Rituximab
n=22 Participants
Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.
Methylprednisolone: 250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Etoposide: 40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cytarabine: 2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cisplatin: 25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be admin
|
|---|---|
|
Median Time to Progression
|
10 months
Interval 8.0 to 18.0
|
SECONDARY outcome
Timeframe: 5 yearsTo evaluate the overall (ORR) response rate with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. Descriptive and summary statistics for demographic and clinical variables obtained. The incidences of reported adverse events (AEs) tabulated. Kaplan-Meier survival analysis for PFS and OS performed on TPP. All the analyses were performed using Stata \[12\].
Outcome measures
| Measure |
ESHAP Followed by Zevalin and Rituximab
n=22 Participants
Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.
Methylprednisolone: 250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Etoposide: 40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cytarabine: 2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cisplatin: 25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be admin
|
|---|---|
|
Overall Response Rate
|
77.3 percentage of participants
|
SECONDARY outcome
Timeframe: 5 yearsTo evaluate the complete (CR) response rate with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy
Outcome measures
| Measure |
ESHAP Followed by Zevalin and Rituximab
n=22 Participants
Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.
Methylprednisolone: 250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Etoposide: 40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cytarabine: 2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cisplatin: 25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be admin
|
|---|---|
|
Complete Response Rate
|
10 Participants
|
Adverse Events
ESHAP Followed by Zevalin and Rituximab
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ESHAP Followed by Zevalin and Rituximab
n=28 participants at risk
Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.
Methylprednisolone: 250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Etoposide: 40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cytarabine: 2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cisplatin: 25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be admin
|
|---|---|
|
Gastrointestinal disorders
Perforated duodenal ulcer
|
3.6%
1/28 • Five years
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
3.6%
1/28 • Five years
|
|
Blood and lymphatic system disorders
Myelodysplastic syndrome
|
7.1%
2/28 • Five years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.6%
1/28 • Five years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metachronous colon carcinoma
|
3.6%
1/28 • Five years
|
Other adverse events
| Measure |
ESHAP Followed by Zevalin and Rituximab
n=28 participants at risk
Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.
Methylprednisolone: 250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Etoposide: 40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cytarabine: 2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
Cisplatin: 25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be admin
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
71.4%
20/28 • Five years
|
|
General disorders
Fatigue
|
75.0%
21/28 • Five years
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
21/28 • Five years
|
|
Blood and lymphatic system disorders
Leukopenia
|
67.9%
19/28 • Five years
|
|
Gastrointestinal disorders
Nausea
|
64.3%
18/28 • Five years
|
|
General disorders
Pain
|
57.1%
16/28 • Five years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia
|
35.7%
10/28 • Five years
|
|
Blood and lymphatic system disorders
Neutropenia
|
32.1%
9/28 • Five years
|
|
Metabolism and nutrition disorders
Anorexia
|
32.1%
9/28 • Five years
|
|
Gastrointestinal disorders
Constipation
|
25.0%
7/28 • Five years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
7/28 • Five years
|
|
Nervous system disorders
Dizziness
|
21.4%
6/28 • Five years
|
|
Gastrointestinal disorders
Diarrhea
|
17.9%
5/28 • Five years
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
4/28 • Five years
|
|
Nervous system disorders
Neuropathy
|
17.9%
5/28 • Five years
|
|
Metabolism and nutrition disorders
Weight loss
|
17.9%
5/28 • Five years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
4/28 • Five years
|
|
Ear and labyrinth disorders
Tinnitus
|
14.3%
4/28 • Five years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.7%
3/28 • Five years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place