Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma
2018년 12월 14일 업데이트: Pfizer
A Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma
To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).
연구 개요
연구 유형
중재적
등록 (실제)
79
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Mainz, 독일, 55131
- Universitaetsmedizin der Johannes Gutenberg-Universitaet
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Muenchen, 독일, 81377
- Medizinische Klinik und Poliklinik III, Klinikum der Universitat Muenchen-Grosshadern
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Muenchen, 독일, 81377
- Universitaet Muenchen Klinikum Grosshadern
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NRW
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Bonn, NRW, 독일, 53105
- Universitatsklinikum Bonn
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, 미국, 35233
- UAB CCC Clinical Studies Unit
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Birmingham, Alabama, 미국, 35233
- University of Alabama at Birmingham Kirklin Clinic
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Birmingham, Alabama, 미국, 35294
- UAB Russell Ambulatory Pharmacy
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern Memorial Hospital
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Chicago, Illinois, 미국, 60611
- Northwestern Medical Faculty Foundation
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New York
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Buffalo, New York, 미국, 14263
- Roswell Park Cancer Institute
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Ohio
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Cleveland, Ohio, 미국, 44195
- The Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania
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Texas
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Houston, Texas, 미국, 77030-4009
- M.D. Anderson Cancer Center
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Leuven, 벨기에, 3000
- Universitair Ziekenhuis Gasthuisberg
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Lausanne, 스위스, 1011
- Centre Hospitalier Universitaire Vaudois
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Barcelona, 스페인, 08025
- Hospital de La Santa Creu i Sant Pau
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Barcelona, 스페인, 08036
- Hospital Clinic I Provincial
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London, 영국, EC1A 7BE
- St Bartholomew's Hospital
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Paris, 프랑스, 75010
- Hopital Saint Louis
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Pierre Benite Cedex, 프랑스, 69495
- Centre Hospitalier Lyon-Sud
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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 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according to WHO classification, which has progressed after at least 2 prior therapies of probable clinical benefit
- At the expanded cohort, part 2 of the study, subjects must have one of the following:
- Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy
- Diffuse large B-cell lymphoma
- Age 18 years or older
Exclusion Criteria:
- Candidate for potentially curative therapies in the opinion of the investigator
- Chronic lymphocytic leukemia
- Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic lymphoma
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
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Inotuzumab ozogamicin
Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2
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CMC-544, IV, dose escalation trial
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: Baseline up to 42 days after last dose of study drug (up to Day 225)
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent adverse events (TEAE) are defined as any new event reported after first dose of study drug up to 42 days after last dose of study drug, or any event that is worse in severity than at any time during the baseline period.
AEs included both SAEs and non-serious adverse events (non-SAEs).
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Baseline up to 42 days after last dose of study drug (up to Day 225)
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Number of Participants With Grade 3 or Higher Grades Treatment-Emergent Adverse Events (TEAEs) Based on Severity
기간: Baseline up to 42 days after last dose of study drug (up to Day 225)
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AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
AE severity was defined to be the maximum toxicity grade of the treatment-emergent adverse events (TEAEs) experienced by the participants during the study.
AE was assessed according to severity; Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening or disabling AE), Grade 5 (death related to AE).
Participants with Grade 3 or higher grades TEAEs were reported.
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Baseline up to 42 days after last dose of study drug (up to Day 225)
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Maximum Tolerated Dose (MTD): Part 1 (Dose Escalation Cohorts)
기간: Baseline up to Day 28
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MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT).
DLT was defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 2 weeks.
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Baseline up to Day 28
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Number of Participants With Dose-limiting Toxicity (DLT)
기간: Baseline up to Day 28
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DLT was classified as per National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 3.0 and defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 14 days.
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Baseline up to Day 28
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
기간: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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PFS was based on Kaplan-Meier estimates.
PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per the International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Progression-Free Survival (PFS): Intent-to-treat Population-Part 2 (Lead-in + Expanded Cohorts)
기간: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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PFS was based on Kaplan-Meier estimates.
PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Overall Survival (OS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
기간: Baseline up to Year 5
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OS was based on Kaplan-Meier method.
Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline up to Year 5
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Overall Survival (OS): Intent-to-treat Population: Part 2 (Lead-in + Expanded Cohorts)
기간: Baseline up to Year 5
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Interval OS was based on Kaplan-Meier method.
Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline up to Year 5
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Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)
기간: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Participants with BOR=with complete response(CR),unconfirmed CR(CRu) or partial response (PR) as per International Response Criteria for NHL.
CR: Total disappearance of all detectable clinical,radiographic sign of disease/related symptoms,normalization biochemical abnormalities related to NHL;if enlarged before therapy all lymph nodes,nodal masses,other organs regressed to normal size and spleen regressed in size,undetectable on physical exam,clear bone marrow infiltrate.
CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow.
PR:>=50% decrease in sum of products of greatest diameters(SPD) of 6 largest dominant nodes/nodal masses,no increase in size of other nodes/spleen/liver, 50% decrease in SPD of splenic,hepatic nodules,involvement of other organs considered assessable,not measurable disease with exception of splenic,hepatic nodules.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Duration of Overall Response (DoR): Part 2 (Lead-in + Expanded Cohorts)
기간: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Duration of overall response was defined as the time from the date that measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the first date that relapsed disease was objectively documented as per International Response Criteria for NHL, taking as reference for relapsed disease the smallest measurements recorded since the treatment started.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Time-to-Tumor Progression: Part 2 (Expanded Cohorts)
기간: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Time to tumor progression was defined as the interval from the start of the treatment until the first date on which relapsed disease or progression is documented, censored at the last disease assessment.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants With Objective Response- Evaluable Population: Part 2 (Lead-in + Expanded Cohorts)
기간: Baseline up to 42 days after last dose (Day 225)
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Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL.
CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate.
CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow.
PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.
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Baseline up to 42 days after last dose (Day 225)
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Percentage of Participants With Objective Response- Intent-to-treat Population: Part 2 (Lead in+ Expanded Cohorts)
기간: Baseline up to 42 days after last dose of study drug (Day 225)
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Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL.
CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate.
CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow.
PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.
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Baseline up to 42 days after last dose of study drug (Day 225)
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (실제)
2003년 8월 1일
기본 완료 (실제)
2010년 12월 1일
연구 완료 (실제)
2010년 12월 1일
연구 등록 날짜
최초 제출
2003년 12월 4일
QC 기준을 충족하는 최초 제출
2003년 12월 4일
처음 게시됨 (추정)
2003년 12월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 12월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 12월 14일
마지막으로 확인됨
2018년 12월 1일
추가 정보
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. .