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BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

2020년 8월 10일 업데이트: Boehringer Ingelheim

A Phase I, Open-Label, Dose-Escalation Trial With BI 836826 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma of B Cell Origin

The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma with at least prior treatments.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

48

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 대한민국
      • Seoul, 대한민국, 135-710
        • Samsung Medical Center
      • Seoul, 대한민국, 110-744
        • Seoul National University Hospital
  • 독일
      • Berlin, 독일, 12200
        • Charité - Universitätsmedizin Berlin
      • Dresden, 독일, 01307
        • Universitatsklinikum Carl Gustav Carus Dresden
      • Frankfurt am Main, 독일, 60590
        • Universitätsklinikum Frankfurt
      • Göttingen, 독일, 37075
        • Universitätsmedizin Göttingen, Georg-August-Universität
      • Hamburg, 독일, 20099
        • Asklepios Klinik St. Georg
      • Heidelberg, 독일, 69120
        • Universitätsklinikum Heidelberg
      • Jena, 독일, 07740
        • Universitätsklinikum Jena
      • Ulm, 독일, 89081
        • Universitätsklinikum Ulm
  • 프랑스
      • Marseille Cedex 09, 프랑스, 13273
        • INS Paoli-Calmettes
      • Pierre Bénite, 프랑스, 69495
        • HOP Lyon Sud

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:

  1. Patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin (mature B cell lymphoma according to WHO) not considered candidates for intensive anti-lymphoma therapy
  2. Patients must have either aggressive NHL and received at least one prior anti-CD20 containing immunochemotherapy or indolent NHL and received anti-CD20 therapy and at least two prior therapies
  3. Measurable disease on computed tomography (CT) scan with involvement of one clearly demarcated lesion =2 cm or two or more clearly demarcated lesions of >1.5 cm at longest diameter (this criterion applies only for the expansion cohort)
  4. Relapse or progression of disease with an indication for therapy as per investigator's judgement
  5. Life expectancy of =3 months
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion criteria:

  1. Primary central nervous system (CNS) lymphoma or known CNS involvement
  2. Prior history of malignancy other than a mature B cell neoplasm according to WHO classification (except basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the uterine cervix or breast treated with curative therapy) unless the subject has been free of disease and without treatment for at least 5 years
  3. Last chemotherapy <4 weeks prior to visit 1
  4. Last anti-CD20 therapy (non-radiolabelled) <4 weeks prior to visit 1
  5. Last corticosteroid <2 weeks prior to visit 1 unless the dose is less or equal of 10 mg/day prednisolone or equivalent
  6. High-dose therapy with stem cell support <6 months prior to visit 1
  7. Radio-immunotherapy <3 months prior to visit 1

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
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Patients with relapsed or refractory NHL
Adult patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin after at least two prior treatments
의약품: BI 836826
Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
기간: From the first administration of trial medication to 7 days after the second administration, upto 36 days
The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients. The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course. In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration.. A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826.
From the first administration of trial medication to 7 days after the second administration, upto 36 days
Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients
기간: From the first administration of trial medication to 7 days after the second administration, up to 36 days
Number of subjects with Dose Limiting Toxicities (DLT) in first Cycle during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL).
From the first administration of trial medication to 7 days after the second administration, up to 36 days

2차 결과 측정

결과 측정
측정값 설명
기간
Tumour Size Reduction
기간: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
Tumour size reduction (lymph nodes, spleen, & liver nodules) defined as best percentage change from baseline in sum of products of diameter (SPD). Negative value represents decrease in tumour size, & positive value represents an increase in size. The tumour size of lymph nodes was to be measured as SPD of 2 perpendicular dimensions for up to 6 indicator lesions identified at baseline CT scan. Spleen & liver were to be described if considered enlarged at baseline by physical examination or CT scan. If nodules present in spleen &/or liver, was to be measured in 2 perpendicular dimensions. Median, 25th & 75th percentiles are calculated from unadjusted Kaplan-Meier curve for each treatment cohort.
Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
Best Overall Response Based on All Assessment
기간: Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)

Best overall response was best response at any of CT scans and investigator assesment (incase the recent CT scan was not available). Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:

  1. Complete remission (CR)
  2. Complete remission unconfirmed (CRu)
  3. Partial remission (PR)
  4. Stable disease (SD)
  5. progressive disease (PD)
Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)
Best Overall Response Based on Imaging Data
기간: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.

Best overall response based on imaging data. Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:

  1. Complete remission
  2. Complete remission unconfirmed
  3. Partial remission
  4. Stable disease:
  5. progressive disease
Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
Progression Free Survival (PFS)
기간: from first treatment until disease progression or death from any cause, up to 12 months.

PFS was defined as the time from first treatment with BI 836826 until disease progression or death from any cause. For disease progression one of the following criteria was required:

• Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort.
from first treatment until disease progression or death from any cause, up to 12 months.
Failure Free Survival (FFS)
기간: from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.

FFS was defined as the time from first treatment with BI 836826 until objective disease progression, death, or start of next Non-Hodgkin lymphoma (NHL) therapy.For disease progression one of the following criteria was required:

• Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort.
from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

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 (실제)

2011년 8월 1일

기본 완료 (실제)

2017년 11월 14일

연구 완료 (실제)

2018년 2월 28일

연구 등록 날짜

최초 제출

2011년 7월 26일

QC 기준을 충족하는 최초 제출

2011년 7월 26일

처음 게시됨 (추정)

2011년 7월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 8월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 8월 10일

마지막으로 확인됨

2020년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1270.2
  • 2010-024456-29 (EudraCT 번호)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

림프종, 비호지킨에 대한 임상 시험

BI 836826에 대한 임상 시험

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스폰서 및 공동 작업자

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약물 개입

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