Trial Outcomes & Findings for Study Comparing Zevalin Regimen With no Further Treatment in Patients With Diffuse Large B-cell Lymphoma. (NCT NCT00322218)

Results Overview

The primary analysis was based on the full analysis set (FAS). Actually, the prominent efficacy variable OS was analysed in the FAS (identical to the safety analysis set) and Per Protocol Set using Kaplan Meier estimates by treatment group. "Overall survival" was defined as the median time interval (in months)from randomization to death from any cause.This time-to-event variable was censored at the date of the last known follow-up visit (provided that the patient was still alive at that time).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

68 participants

Primary outcome timeframe

5 years or until patient dies or lost to follow up

Results posted on

2022-01-19

Participant Flow

Diffuse large B-cell lymphoma (DLBCL) Patients at the age of at least 60 years and in complete remission (CR or CRu) after 6 or 8 cycles of a first-line treatment with Cyclophosphamide Doxorubicin hydrochloride Vincristine Prednisolone- Rituximab (CHOP-R) were enrolled in the study.

Of the 151 screened patients 68 patients were assigned to treatment (Full analysis set, FAS). Three patients showed major protocol deviations and thus were excluded from the "per protocol set"(PPS). The PPS comprised 65 patients.

Participant milestones

Participant milestones
Measure	Zevalin Zevalin Therapeutic Regimen: Day 1: 250 milligram per meter square (mg/m\^2) Rituxan followed by 5 millicurie (mCi) 111In Zevalin. Day 7: 250 mg/m\^2 Rituxan followed by 0.4 millicurie/kilogram (mCi/kg) Zevalin.	Observation Patients in this arm were diagnosed with diffuse large B-cell lymphoma and were in complete remission after first-line CHOP-R therapy. Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse.
Overall Study STARTED	34	34
Overall Study Per-Protocol Set	33	32
Overall Study COMPLETED	31	28
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Zevalin Zevalin Therapeutic Regimen: Day 1: 250 milligram per meter square (mg/m\^2) Rituxan followed by 5 millicurie (mCi) 111In Zevalin. Day 7: 250 mg/m\^2 Rituxan followed by 0.4 millicurie/kilogram (mCi/kg) Zevalin.	Observation Patients in this arm were diagnosed with diffuse large B-cell lymphoma and were in complete remission after first-line CHOP-R therapy. Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse.
Overall Study Death	3	6

Baseline Characteristics

Study Comparing Zevalin Regimen With no Further Treatment in Patients With Diffuse Large B-cell Lymphoma.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zevalin n=34 Participants Zevalin Therapeutic Regimen: Day 1: 250 mg/m\^2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m\^2 Rituxan followed by 0.4 mCi/kg Zevalin.	Observation n=34 Participants Patients in this arm were diagnosed with diffuse large B-cell lymphoma and were in complete remission after first-line CHOP-R therapy. Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse.	Total n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants	28 Participants n=7 Participants	59 Participants n=5 Participants
Age, Continuous	70.2 years STANDARD_DEVIATION 4.6 • n=5 Participants	68.8 years STANDARD_DEVIATION 4.8 • n=7 Participants	69.5 years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years or until patient dies or lost to follow up

Population: This study was completed in 2008. We have exhausted all efforts and unfortunately, the data cannot be located in our records. Therefore, no data is available to report for this outcome measure.

The primary analysis was based on the full analysis set (FAS). Actually, the prominent efficacy variable OS was analysed in the FAS (identical to the safety analysis set) and Per Protocol Set using Kaplan Meier estimates by treatment group. "Overall survival" was defined as the median time interval (in months)from randomization to death from any cause.This time-to-event variable was censored at the date of the last known follow-up visit (provided that the patient was still alive at that time).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years or until patient disease progresses or lost to follow up

DFS was analysed in the FAS (identical to the safety analysis set) and Per Protocol set using Kaplan Meier estimates by treatment group.Disease-free survival was defined as the median time interval (in months) from randomization to the date of relapse (as assessed by the investigator) or death from any cause. This time-to-event variable was also censored at the date of the last known follow-up visit (provided that the patient was still alive at that time).

Outcome measures

Outcome measures
Measure	Zevalin n=34 Participants Zevalin Therapeutic Regimen: Day 1: 250 mg/m\^2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m\^2 Rituxan followed by 0.4 mCi/kg Zevalin.	Observation n=34 Participants Patients in this arm were diagnosed with diffuse large B-cell lymphoma and were in complete remission after first-line CHOP-R therapy. Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse.
Proportion of Participants With Disease Free Survival (DFS)	0.7058 proportion of participants	0.7957 proportion of participants

SECONDARY outcome

Timeframe: Up to Month 36

HRQL questionnaire consists of 27 questions each scores ranging from 0 - 4. The minimum score was 0 which is termed as 'worst imaginable health state' and the maximum score for a patient was 100 which is termed as 'best imaginable health state'. The descriptive classification defines health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension is subdivided into 3 levels: no problem, some or moderate problems, unable or extreme problems.

Outcome measures

Outcome measures
Measure	Zevalin n=34 Participants Zevalin Therapeutic Regimen: Day 1: 250 mg/m\^2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m\^2 Rituxan followed by 0.4 mCi/kg Zevalin.	Observation n=34 Participants Patients in this arm were diagnosed with diffuse large B-cell lymphoma and were in complete remission after first-line CHOP-R therapy. Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse.
The Health-related Quality of Life (HRQL)	84.2 scores on a scale Standard Deviation 14.2	88.7 scores on a scale Standard Deviation 12.6

Adverse Events

Zevalin

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Observation

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zevalin n=34 participants at risk Zevalin Therapeutic Regimen: Day 1: 250 mg/m\^2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m\^2 Rituxan followed by 0.4 mCi/kg Zevalin.	Observation n=34 participants at risk Patients in this arm were diagnosed with diffuse large B-cell lymphoma and were in complete remission after first-line CHOP-R therapy. Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse.
Blood and lymphatic system disorders cytopenia	5.9% 2/34 • Number of events 3 • Followed up until last anti-lymphoma treatment or 42 months whichever is longer. Only study drug-related AEs was collected until the end of Stage 1 in case of a relapse.Patients who relapsed before study treatment were to be followed up in the same way as patients in observation arm,if a patient randomized to the observation arm received treatment for a relapse, no further AE reporting was required.	2.9% 1/34 • Number of events 1 • Followed up until last anti-lymphoma treatment or 42 months whichever is longer. Only study drug-related AEs was collected until the end of Stage 1 in case of a relapse.Patients who relapsed before study treatment were to be followed up in the same way as patients in observation arm,if a patient randomized to the observation arm received treatment for a relapse, no further AE reporting was required.

Other adverse events

Other adverse events
Measure	Zevalin n=34 participants at risk Zevalin Therapeutic Regimen: Day 1: 250 mg/m\^2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m\^2 Rituxan followed by 0.4 mCi/kg Zevalin.	Observation n=34 participants at risk Patients in this arm were diagnosed with diffuse large B-cell lymphoma and were in complete remission after first-line CHOP-R therapy. Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse.
Infections and infestations Infections and manifestations	14.7% 5/34 • Number of events 5 • Followed up until last anti-lymphoma treatment or 42 months whichever is longer. Only study drug-related AEs was collected until the end of Stage 1 in case of a relapse.Patients who relapsed before study treatment were to be followed up in the same way as patients in observation arm,if a patient randomized to the observation arm received treatment for a relapse, no further AE reporting was required.	2.9% 1/34 • Number of events 6 • Followed up until last anti-lymphoma treatment or 42 months whichever is longer. Only study drug-related AEs was collected until the end of Stage 1 in case of a relapse.Patients who relapsed before study treatment were to be followed up in the same way as patients in observation arm,if a patient randomized to the observation arm received treatment for a relapse, no further AE reporting was required.

Additional Information

Gajanan Bhat

Spectrum Pharmaceuticals,Inc.

Phone: 949-743-9219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place