A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia
2019년 6월 17일 업데이트: Celgene
A Phase 2, Multicenter, Randomized, Open-label, Parallel-group Study of a Lenalidomide (Revlimid®) Regimen or a Sequential Azacitidine (Vidaza®) Plus Lenalidomide (Revlimid®) Regimen Versus an Azacitidine (Vidaza®) Regimen for Therapy of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia
The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).
연구 개요
상태
완전한
상세 설명
On September 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was temporarily suspended based on review of the data from the first 13 participants and a high rate of discontinuation (11/13 participants).
The Data Monitoring Committee assessed the study data on September 20, 2013 and reported no safety concerns.
The high rate of early discontinuation is inconsistent with the treatment duration required for testing the study primary endpoint of survival at one year.
Consequently, Celgene has decided not to reopen the lenalidomide only arm.
연구 유형
중재적
등록 (실제)
88
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Arizona
-
Tucson, Arizona, 미국, 85724
- (210) University of Arizona Cancer Center
-
-
California
-
La Jolla, California, 미국, 92093-0960
- (180) University of California, San Diego
-
Los Angeles, California, 미국, 90048
- (240) Cedars-Sinai Medical Center
-
Orange, California, 미국, 92868
- (215) Hematology Oncology Medical Group
-
Sacramento, California, 미국, 95857
- (130) UC Davis Medical Center
-
San Luis Obispo, California, 미국, 93401
- (200) Coastal Integrative Cancer Care
-
Stanford, California, 미국, 94305
- (125) University of Stanford
-
-
Colorado
-
Aurora, Colorado, 미국, 80045
- (115) University of Colorado Anschultz Cancer Center
-
-
Florida
-
Miami Beach, Florida, 미국, 33140
- (145) Mount Sinai Comprehensive Cancer Center
-
-
Illinois
-
Chicago, Illinois, 미국, 60612
- (140) Rush University Medical Center
-
-
Kansas
-
Westwood, Kansas, 미국, 66205
- (185) The University of Kansas Cancer Center
-
-
Kentucky
-
Louisville, Kentucky, 미국, 40202
- (175) University Lousiville
-
-
Louisiana
-
New Orleans, Louisiana, 미국, 70072
- (195) Tulane University Hospital Tulane Cancer Center
-
-
Minnesota
-
Minneapolis, Minnesota, 미국, 55455
- (235) University of Minnesota
-
-
Missouri
-
Saint Louis, Missouri, 미국, 63110-1093
- (100) Washington University School of Medicine
-
-
Montana
-
Billings, Montana, 미국, 59101
- (150) Billings Clinic
-
-
New York
-
New York, New York, 미국, 10029-65749
- (165) Mount Sinai Medical Center New York
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, 미국, 15224-1791
- (160) The Western Pennsylvania Hospital- Cancer Institute
-
-
South Carolina
-
Greenville, South Carolina, 미국, 29605
- (205) Greenville Hospital System
-
-
South Dakota
-
Sioux Falls, South Dakota, 미국, 57105
- (120) Avera Cancer Institute
-
-
Tennessee
-
Nashville, Tennessee, 미국, 37203
- (230) Tennessee Oncology, PLLC
-
-
Texas
-
Dallas, Texas, 미국, 75390-9179
- (105) University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center
-
San Antonio, Texas, 미국, 78229
- (155) Cancer Care Centers of South Texas
-
-
Wisconsin
-
Madison, Wisconsin, 미국, 53792
- (135) University of Wisconsin
-
-
-
-
Alberta
-
Calgary, Alberta, 캐나다, T2N 4N2
- (402) Tom Baker Cancer Centre
-
Edmonton, Alberta, 캐나다, T6G 1Z1
- (405) University of Alberta Hospital
-
-
Manitoba
-
Winnipeg, Manitoba, 캐나다, R3E 0V9
- (401) Cancer Care Manitoba
-
-
Nova Scotia
-
Halifax, Nova Scotia, 캐나다, B3H 2Y9
- (403) Queen Elizabeth II Health Sciences Centre - VG Site
-
-
Ontario
-
Ottawa, Ontario, 캐나다, K1H 8L6
- (404) The Ottawa Hospital
-
Toronto, Ontario, 캐나다, M5G 2M9
- (400) Princess Margaret Hospital
-
-
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
65년 이상 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder or therapy-related AML
- Male or female subjects aged ≥ 65
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- White blood cell (WBC) count ≤ 10 x 10⁹/L at screening
Exclusion Criteria:
- Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide
- Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted therapy agents.
- Suspected or proven acute promyelocytic leukemia
- Prior bone marrow or stem cell transplantation
- Candidate for allogeneic bone marrow or stem cell transplantation
- AML antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms
- Presence of malignant disease within the previous 12 months with exceptions
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Lenalidomide in combination with azacitidine
Repeated cycles of azacitidine 75 mg/m^2/day subcutaneous (SC) on Days 1-7 and lenalidomide 50 mg/day by mouth (PO) on Days 8-28 followed by a 14-day break plus best supportive care
|
Azacitidine at 75 mg/m^2/day subcutaneous on Days 1-7
다른 이름들:
Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily
다른 이름들:
The use of BSC was considered as concomitant treatment and must be documented as concomitant medication. BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support |
|
실험적: Lenalidomide - single agent
Lenalidomide 50 mg PO daily for 28 days for the first 2 cycles and lenalidomide 25 mg daily for 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg daily PO plus best supportive care
|
Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily
다른 이름들:
The use of BSC was considered as concomitant treatment and must be documented as concomitant medication. BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support |
|
실험적: Azacitidine-single agent
Repeated cycles of azacitidine 75mg/m^2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care
|
Azacitidine at 75 mg/m^2/day subcutaneous on Days 1-7
다른 이름들:
The use of BSC was considered as concomitant treatment and must be documented as concomitant medication. BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Kaplan Meier Estimates for One Year Survival
기간: Up to 24 months
|
One-year survival rate was defined as all deaths within one year from the date of randomization.
All others censored at the at year 1 or date of discontinuation
|
Up to 24 months
|
|
Overall Survival
기간: From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)
|
Overall Survival reported at the end of the study are for those participants who were alive at the end of the study
|
From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants With a Complete Response or Morphologic Incomplete Response.
기간: Complete Response or Morphologic Incomplete Response data not analyzed.
|
Based on IWG response criteria for AML. Complete remission (CR), morphologic complete remission (CR) was defined as < 5% bone marrow blasts, an absolute neutrophil count ≥ 1 x 10^9/L, platelets ≥100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response. Morphologic CR with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC count may be <1 x 10^9/L and/or the platelet count may be <100 x 10^9/L. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed. |
Complete Response or Morphologic Incomplete Response data not analyzed.
|
|
Duration of Remission (DoR)
기간: Duration of Remission (DoR) time frame not analyzed.
|
Duration of remission was defined as the time from the date of CR or CRi until relapse.
Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
|
Duration of Remission (DoR) time frame not analyzed.
|
|
Cytogenetic Complete Remission Rate (CRc)
기간: Cytogenetic Complete Remission timeframe was not analyzed.
|
The CRc response category is comprised of the subset of participants who had abnormal cytogenetics at baseline and subsequently achieved CR during treatment in conjunction with a reversion to a normal karyotype.
For the primary definition of CRc, a normal karyotype is defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques.
Cytogenetic complete remission rate (CRc) 1) CR criteria met AND 2) Abnormal karyotype present at baseline AND 3) Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment.
Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
|
Cytogenetic Complete Remission timeframe was not analyzed.
|
|
Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)
기간: Overall response rate time frame was not analyzed.
|
Morphologic complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a one marrow aspirate with spicules and with at least 200 nucleated cells (there should be no blasts with auer rods) and ANC of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, no transfusions for 1 week prior to each assessment.
No duration of these findings is required for confirmation of this response.
Morphologic complete remission with incomplete blood count recovery was defined as a morphologic complete remission but the ANC may be < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L.
Partial remission was defined as an ANC > 1 x 10^9/L and platelet count ≥ 100 x 10^9/L with a > 50% decrease in the percentage of bone marrow blasts to 5% to 25% (a blast count value of ≤ 5% may also be considered a partial remission if auer rods are present).
Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
|
Overall response rate time frame was not analyzed.
|
|
Progression-Free Survival (PFS)
기간: Progression-Free survival data and time frame was not analyzed.
|
PFS is defined as the time from randomization to the first observation of documented disease progression or death from any cause whichever occurred first.
Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
|
Progression-Free survival data and time frame was not analyzed.
|
|
Event-Free Survival (EFS)
기간: Event-Free survival time was not analyzed.
|
EFS was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after CR or CRi, or death from any cause, whichever occurred first.
Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
|
Event-Free survival time was not analyzed.
|
|
Relapse-Free Survival (RFS)
기간: Relapse-Free survival time frame was not analyzed.
|
RFS is defined only for subjects that achieve CR and CRi and is measured as the interval from that date to the date of disease relapse, death from any cause, whichever occurs first, censoring at the last visit date for subjects alive in continuous CR/CRi.
Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
|
Relapse-Free survival time frame was not analyzed.
|
|
Percentage of Participants With 30-Day Treatment-Related Mortality
기간: 30 days
|
30-day mortality rate was defined as death from any cause within 30 days after first dose.
|
30 days
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE)
기간: From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018
|
TEAEs were defined as those events that started on or after the first day of study drug up until 28 days after the last dose of study drug; Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; constitutes an important medical event.
Severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); and according to the scale: Grade (Gr) 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
|
From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018
|
|
Number of Participants With a Second Primary Malignancy
기간: From randomization of the last participant up to a minimum of 4 years following discontinuation
|
Second primary malignancies were monitored as events of interest and reported as serious adverse events regardless of the treatment arm the participant was enrolled in.
|
From randomization of the last participant up to a minimum of 4 years following discontinuation
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Alive at One Year
기간: Up to 12 months
|
Defined as the percentage of participants who survived at one year
|
Up to 12 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Robert Gale, MD, Celgene
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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)
2012년 4월 27일
기본 완료 (실제)
2015년 5월 19일
연구 완료 (실제)
2018년 5월 15일
연구 등록 날짜
최초 제출
2011년 5월 19일
QC 기준을 충족하는 최초 제출
2011년 5월 20일
처음 게시됨 (추정)
2011년 5월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 6월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 6월 17일
마지막으로 확인됨
2019년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CC-5013-AML-001
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. .