SNDX-5613용 확장 액세스 프로그램
HOXA 과발현과 관련된 유전자 변형이 있는 재발성/불응성 급성 백혈병 환자의 SNDX-5613에 대한 확장 액세스 프로그램
This expanded access program will provide an investigational treatment option in a controlled clinical setting for participants who are not otherwise eligible to participate in other Syndax-sponsored clinical studies and have no approved treatment options.
연구 개요
연구 유형
확장 액세스 유형
- 치료 IND/프로토콜
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35233
- Alabama Center for Childhood Cancer And Blood Disorders, Children's of Alabama
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Arizona
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Phoenix, Arizona, 미국, 85016
- Phoenix Children's Hospital
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California
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Duarte, California, 미국, 91010
- City of Hope
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Irvine, California, 미국, 92618
- City of Hope at Orange County Lennar Foundation Cancer Center
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Los Angeles, California, 미국, 90095
- UCLA, UCLA RRMC, Drug Information Center, Department of Pharmaceutical Services Drug Supply Shipment
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Palo Alto, California, 미국, 94304
- Lucile Packard Children's Hospital-Stanford
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San Diego, California, 미국, 92123
- Rady Children's Hospital
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San Francisco, California, 미국, 94158
- University of California, San Francisco
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Colorado
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Aurora, Colorado, 미국, 80045
- Center for Cancer and Blood Disorders, Colorado Children's Hospital
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Aurora, Colorado, 미국, 80045
- HCTU, Division of Hematology, University of Colorado, Anschutz Medical Center
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Florida
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Orlando, Florida, 미국, 32804
- Advent Health Orlando
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Georgia
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Atlanta, Georgia, 미국, 30322
- Children's Healthcare of Atlanta
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Atlanta, Georgia, 미국, 30322
- Winship Cancer Institute at Emory University
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Illinois
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Chicago, Illinois, 미국, 60611
- Lurie Children's Hospital of Chicago
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Chicago, Illinois, 미국, 60637
- University of Chicago Medical Center
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Iowa
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Iowa City, Iowa, 미국, 52242
- University of Iowa Hospitals and Clinics
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Louisiana
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New Orleans, Louisiana, 미국, 70118
- Children's Hospital
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Dana-Farber Cancer Institute, Boston Children's Cancer and Blood Disorders Center
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Missouri
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Kansas City, Missouri, 미국, 64108
- Children's Mercy Hospital-Kansas City
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St Louis, Missouri, 미국, 63110
- Siteman Cancer Center - Washington University
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- Hackensack University Medical Center
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New York
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Long Island City, New York, 미국, 10065
- Memorial Sloan Kettering Cancer Center
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The Bronx, New York, 미국, 10467
- Montefiore Medical Center
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North Carolina
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Durham, North Carolina, 미국, 27705
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, 미국, 45229
- Cincinnati Children's Hospital Medical Center
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Cincinnati, Ohio, 미국, 45267
- Division of Hematology and Oncology, Division of Pulmonary, Critical Care and Sleep Medicine, Vontz Center for Molecular Studies
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Columbus, Ohio, 미국, 43210
- OSU Medical Center
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Oregon
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Portland, Oregon, 미국, 97239
- Doernbecher Children's Hospital, Oregon Health & Science University
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Children's Hospital of Philadelphia
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Tennessee
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Memphis, Tennessee, 미국, 38105
- St. Jude Children's Research Hospital
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Texas
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Houston, Texas, 미국, 77030
- MD Anderson Cancer Center
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Houston, Texas, 미국, 77030
- Texas Children's Hospital
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Houston, Texas, 미국, 77030
- Memorial Hermann-Texas Medical Center
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Utah
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Salt Lake City, Utah, 미국, 84112
- Division of Hematology and Hematologic Malignancies, University of Utah-Huntsman Cancer Hospital
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Washington
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Seattle, Washington, 미국, 98105
- Seattle Children's Research Institute, Seattle Childrens Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
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Male or female participant aged ≥6 months.
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Not eligible for participation in an ongoing clinical study and have no approved treatment options.
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Participant or participant's health care proxy is able and willing to provide written informed consent and able to follow study instructions.
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Relapsed or refractory (R/R) acute leukemia, as defined by standardized criteria, after standard of care therapy, including but not limited to 1 or 2 cycles of intensive chemotherapy, or venetoclax combinations:
- R/R leukemia is defined by the presence of ≥5% blasts in the bone marrow and/or persistence or reappearance of peripheral blasts.
- Participants with persistent leukemia after initial therapy or recurrence of leukemia at any time after achieving a response during or after the course of treatment (including allogeneic hematopoietic stem cell transplant [HSCT]) are eligible.
- Participants with isolated extra-medullary disease are allowed if extramedullary disease was confirmed with biopsy.
- Participants previously treated on a revumenib clinical study who are entering the expanded access program for post-transplant maintenance because they are not eligible to receive revumenib on study or because the study is closed are not required to meet the R/R status.
- Participants who underwent HSCT and are eligible to resume treatment with revumenib will be dosed with the last revumenib tolerated dose before transplant.
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Acute leukemia harboring a lysine (K) methyltransferase 2A gene rearrangement (KMT2Ar), nucleoporin 98 rearrangement, nucleophosmin 1 mutation (or mutated) or any other genetic alteration with overexpression of HOXA genes predicted to potentially respond to menin inhibitors.
- Note: As revumenib is now approved in the United States, only participants with a KMT2Ar who are not included in the United States prescribing information indication or cannot be accurately dosed (within a 20% margin) with commercial supply and require use of oral solution will be allowed into the study.
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Adequate liver, renal, and cardiac function.
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Use of highly effective methods of contraception are required for females and males of childbearing potential from the time of enrollment through 120 days following the last study intervention dose.
For participants currently being treated with revumenib in a Syndax-sponsored clinical study or Syndax investigator-sponsored trial, the following criteria must be met:
- In the opinion of the Investigator, participant demonstrated acceptable benefit from and tolerability of the study intervention.
- Participant is considered compliant with study intervention and procedures.
- Participant does not meet any criteria for study intervention discontinuation.
- Investigator and participant agree to continue study intervention treatment.
- Participant continues to experience clinical benefit.
Key Exclusion Criteria:
- Evidence of uncontrolled infection.
- Pregnant or nursing women.
- Cardiac or gastrointestinal disease.
- Graft-Versus-Host Disease (GVHD): Signs or symptoms of acute or chronic GVHD >Grade 1 within 4 weeks of enrollment. All transplant participants must have been off all systemic immunosuppressive therapy and calcineurin inhibitors for at least 1 week before enrollment, with the exception of steroids.
- History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that, in the Investigator's opinion, either may interfere with the participant's participation or results in the conclusion that it is not in the best interest of the participant to participate.
- Participants receiving other antileukemic therapy within 14 days of start of study drug and who have not recovered from previous adverse reactions.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
공부 계획
연구는 어떻게 설계됩니까?
공동 작업자 및 조사자
수사관
- 연구 책임자: Medical Director, Syndax Pharmaceuticals
연구 기록 날짜
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .