Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant
2015년 7월 2일 업데이트: GlaxoSmithKline
An Open-label, Single-arm. Multi-center Phase 2 Trial With Ofatumumab in Patients With Relapsed/Progressive Diffuse Large B-Cell Lymphoma (DLBCL) Ineligible for Transplant or Relapse/Progression After Autologous Transplant
The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant
연구 개요
연구 유형
중재적
등록 (실제)
81
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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London, 영국, EC1M 6BQ
- GSK Investigational Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
Patients with DLBCL
- and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation
- and relapse after complete remission or disease progression after partial remission following autologous stem cell transplantation.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Ofatumumab
8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg
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8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants With Objective Response
기간: 6-month period from start of treatment (up to Week 24)
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Objective response of ofatumumab treatment was assessed according to the "revised response criteria for malignant lymphoma."
Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease.
CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease.
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6-month period from start of treatment (up to Week 24)
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Number of Participants Classified as Responders and Non-responders for Objective Response
기간: 6-month period from start of treatment (up to Week 24)
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According to the "revised response criteria for malignant lymphoma," responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD).
Participants not evaluable (NE) were also considered to be non-responders.
PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline.
SD is defined as failure to attain CR, PR, or PD.
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6-month period from start of treatment (up to Week 24)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Duration of Response
기간: From date of start of treatment to 2 years or withdrawal
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The duration of response was defined as the time from the initial response (CR or PR) to the time of relapse, progression, or death.
If the participant was lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.
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From date of start of treatment to 2 years or withdrawal
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Progression-free Survival (PFS)
기간: From date of start of treatment to 2 years or withdrawal
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PFS was defined as the time from treatment start until progression or death.
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From date of start of treatment to 2 years or withdrawal
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Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy
기간: From date of start of treatment to 5 years or withdrawal
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Time to next DLBCL therapy was defined as the time from the first infusion date to the time of the first administration of the next DLBCL treatment other than ofatumumab.
If the participants were lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.
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From date of start of treatment to 5 years or withdrawal
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Overall Survival (OS)
기간: From date of start of treatment to 5 years or withdrawal
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Overall survival is defined as the time from first infusion to death.
Overall survival was a secondary endpoint in the study.
However, since many participants withdrew from the study after developing disease progression overall survival could not be reliably estimated.
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From date of start of treatment to 5 years or withdrawal
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Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18
기간: Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)
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HAHA are indicators of immune response to ofatumumab.
Blood samples were collected from participants at Visits 1, 12, 13, 14, and 18 and analyzed in batches.
The number of participants with positive results at each visit is reported.
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Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)
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Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
기간: Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)
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B cells (CD45+CD19+ and CD45+CD20+) were measured in peripheral blood samples by flow cytometry.
Percent change from Baseline = (value at the indicated visits minus the value at Baseline divided by the value at Baseline) * 100.
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Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)
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Number of Participants Who Experienced at Least One Adverse Event (AE)
기간: Time frame is from date of start of treatment to 2 years or withdrawal
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An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
The protocol-defined AE reporting period was from the first infusion (Visit 2/Week 0) to Visit 18 (Month 24 of follow-up) or time of withdrawal (treatment and follow-up).
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Time frame is from date of start of treatment to 2 years or withdrawal
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Percent Change From Screening in Complement (CH50) Levels
기간: Screening and post-baseline visits (last visit was to occur 24 months post first dose)
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CH50 was mistakenly registered as an outcome measure with the protocol record.
Samples were not collected, and no analysis will take place.
Thus, no data will be reported for this outcome measure.
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Screening and post-baseline visits (last visit was to occur 24 months post first dose)
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AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion
기간: Visit 9 (Week 7; up to 11 months after last dose)
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AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure.
AUC(0-168) is the AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is the AUC from the start of infusion extrapolated to infinity.
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Visit 9 (Week 7; up to 11 months after last dose)
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Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions
기간: Visit 2 (Week 0) and Visit 9 (Week 7)
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Cmax is defined as the maximum concentration of drug in serum samples.
Ctrough is defined as the minimum observed concentration prior to the start of the next dose.
No drug is present prior to the first infusion; therefore, there are no Ctrough results for the first dose.
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Visit 2 (Week 0) and Visit 9 (Week 7)
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Half-life (T1/2) for Ofatumumab at the Eighth Infusion
기간: Visit 9 (Week 7; up to 11 months after last dose)
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t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.
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Visit 9 (Week 7; up to 11 months after last dose)
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Clearance (CL) of Ofatumumab at the Eighth Infusion
기간: Visit 9 (Week 7; up to 11 months after last dose)
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CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.
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Visit 9 (Week 7; up to 11 months after last dose)
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Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion
기간: Visit 9 (Week 7; up to 11 months after the last dose)
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Vss is the volume of distribution at steady state of ofatumumab.
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Visit 9 (Week 7; up to 11 months after the last dose)
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스폰서
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2007년 12월 1일
기본 완료 (실제)
2010년 5월 1일
연구 완료 (실제)
2014년 8월 1일
연구 등록 날짜
최초 제출
2008년 2월 13일
QC 기준을 충족하는 최초 제출
2008년 2월 13일
처음 게시됨 (추정)
2008년 2월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 7월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 7월 2일
마지막으로 확인됨
2015년 1월 1일
추가 정보
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