NL-OMON56180招募中2 期
A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients with Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation - SNDX-5613-0700 (ICON 2636/0009): Phase 2 Study in Patients with Leukemias
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 99（—）
入选标准
- •1. Patients in phase 1 Arm A and Arm B must have active acute leukemia
- •harboring KMT2A rearrangement or NPM1 mutation (bone marrow blasts >=5% or
- •reappearance of blasts in peripheral blood) as defined by the National
- •Comprehensive Cancer Network (NCCN) guidelines in the NCCN Clinical Practice
- •Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia
- •(Version 1.2020) and Acute Myeloid Leukemia (Version 3.2020) (National
- •Comprehensive Cancer Network 2020; National Comprehensive Cancer Network 2020).
- •Patients in phase 1 Arm C, Arm D, Arm E and Arm F must meet one of the
- •following 2 criteria:
- •active acute leukemia (bone marrow blasts >=5% or reappearance of blasts in
- •peripheral blood) as defined by the National Comprehensive Cancer Network
- •(NCCN) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
- •for Acute Lymphoblastic Leukemia (Version 1.2020) and Acute Myeloid Leukemia
- •(Version 3.2020) (National Comprehensive Cancer Network 2020; National
- •Comprehensive Cancer Network 2020).
- •acute leukemia harboring an KMT2A rearrangement, NUP98 rearrangement, or NPM1
- •mutation that have detectable disease in the bone marrow not meeting criterion
- •for active leukemia as described above.
- •2. Phase 1: see more details in the protocol.
- •Note that phase 1 is not applicable for the Netherlands.
- •3. 3. Phase 2: Documented R/R active acute leukemia (bone marrow blasts >=5% or
- •reappearance of blasts in peripheral blood) as defined by the NCCN Guidelines®
- •for Acute Lymphoblastic Leukemia (Version 1.2020) and Acute Myeloid Leukemia
- •(Version 3.2020) (National Comprehensive Cancer Network 2020; National
- •Comprehensive Cancer Network 2020).
- •Cohort 2A: Documented R/R ALL/MPAL with a KMT2A rearrangement.
- •Cohort 2B: Documented R/R AML with a KMT2A rearrangement.
- •Cohort 2C: Documented R/R AML with NPM1m.
- •Mutational status is to be reviewed locally to determine patient eligibility in
- •Phase 2 and confirmed centrally. Central confirmation of KMT2Ar status will be
- •obtained by fluorescence in situ hybridization (11q23 MLL-Break Apart FISH
- •testing Flagship Biosciences, Morrisville, NC). NPM1 mutational status
- •confirmation will be obtained by PCR based amplification and sequencing (Focus
- •Myeloid panel, Flagship Biosciences, Morrisville, NC). All assays will be
- •conducted in a CLIA certified laboratory. Patients whose mutational status
- •cannot be confirmed centrally, or whose final pathology or flow reports do not
- •confirm the presence of >=5% bone marrow blasts, will be replaced to ensure a
- •sufficient number of patients for the primary efficacy analyses.
- •Disease Status
- •4. Recurrent or refractory AML/ALL or MPAL, as defined by standardized criteria
- •(for example, European LeukemiaNet criteria [Döhner 2017]; International
- •Working Group criteria [Cheson 2003]) after standard of care therapy, including
- •but not limited to one or two cycles of intensive chemotherapy, or venetoclax
- •combinations.. Patients with persistent leukemia after initial therapy or with
- •recurrence of leukemia at any time after achieving a response during or after
- •the course of treatment (including allogeneic [HSCT] are eligible. Refractory
- •or relapsed leukemia is defined by presence of >=5% blasts in the bone marrow
- •and/or persistence or reappearance of peripheral blasts. Patient
排除标准
- •1. Diagnosis of active acute promyelocytic leukemia.
- •2. Isolated extramedullary relapse (Phase 2 only).
- •3. Active CNS disease (cytologic, such as any blasts on cytospin, or
- •radiographic). Patients who have cleared CNS disease by at least one negative
- •tap prior to dosing may be enrolled, and prophylactic intrathecal chemotherapy
- •may be continued while on trial.
- •The following patients are required to have a lumbar puncture or Ommaya
- •reservoir tap during the screening period:
- •Signs and symptoms of CNS disease
- •AML with monocytic phenotype.
- •WBC >=50,000 /µL at presentation.
- •History of CNS or any extramedullary disease.
- •ALL or MPAL.
- •4. Detectable human immunodeficiency virus (HIV) viral load within the previous
- •6 months. Patients with a known history of HIV 1/2 antibodies must have viral
- •load testing prior to study enrollment.
- •5. Hepatitis B (defined as hepatitis B virus [HBV] surface antigen positive and
- •HBV core antibody positive or positive HBV deoxyribonucleic acid [DNA],
- •6. Hepatitis C (defined as positive hepatitis C [HCV] antibody with reflex to
- •positive HCV ribonucleic acid [RNA]).
- •Pregnancy and Breast-Feeding
- •7. Pregnant or nursing women. Negative serum pregnancy tests are required
- •during Screening and a negative serum or urine pregnancy test is required
- •within 72 hours prior to receiving the first study drug administration, in
- •females of childbearing potential. If the urine test is positive or cannot be
- •confirmed as negative, a serum pregnancy test will be required.
- •Concurrent Conditions
- •8. Cardiac Disease:
- •Any of the following within the 6 months prior to study entry: myocardial
- •infarction, uncontrolled/unstable angina, congestive heart failure (New York
- •Heart Association Classification Class >=II), life-threatening, uncontrolled
- •arrhythmia, cerebrovascular accident, or transient ischemic attack.
- •QTc using Fridericia*s correction (QTcF) >450 msec (Section 8.2.7).
- •9. Gastrointestinal Disease:
- •Any gastrointestinal issue of the upper GI tract likely to affect oral drug
- •absorption or ingestion (gastric bypass, gastroparesis, etc).
- •Cirrhosis with a Child-Pugh score of B or C.
- •10. Graft-Versus-Host Disease (GVHD): Signs or symptoms of acute or chronic
- •GVHD >Grade 0 within 4 weeks of enrollment. All transplant patients must have
- •been off all systemic immunosuppressive therapy and calcineurin inhibitors for
- •at least 4 weeks prior to enrollment. Patients may be on physiological doses of
- •11. Concurrent malignancy in the previous 2 years with the exception of basal
- •cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma
- •in situ (eg, breast carcinoma, cervical cancer in situ, melanoma in situ)
- •treated with potentially curative therapy, or concurrent low-grade lymphoma,
- •that is asymptomatic and lacks bulky disease and shows no evidence of
- •progression, and for which the patient is not receiving any systemic therapy or
- •12. Concurrent malignancy must be in complete remission (CR) or no evidence of
- •disease (NED) during this timeframe.
- •13. History of or any concurrent condition, therapy, laboratory abnormality, or
- 另有 2 项未显示
研究者
相似试验
招募中
1 期
A study to investigate the short- and long-term safety and tolerability of the drug SNDX-5613 in Patients with Relapsed/Refractory Leukemias. Various doses of SNDX-5613 will be investigated.EUCTR2020-004104-34-ITSYNDAX PHARMACEUTICALS, INC.333
进行中（未招募）
1 期
A study to investigate the short- and long-term safety and tolerability of the drug SNDX-5613 in Patients with Relapsed/Refractory Leukemias. Various doses of SNDX-5613 will be investigated.CTIS2024-513759-34-00Syndax Pharmaceuticals Inc.180
招募中
1 期
A study to investigate the short- and long-term safety and tolerability of the drug SNDX-5613 in Patients with Relapsed/Refractory Leukemias. Various doses of SNDX-5613 will be investigated.EUCTR2020-004104-34-LTSyndax Pharmaceuticals, Inc333
进行中（未招募）
1 期
A study to investigate the short- and long-term safety and tolerability of the drug SNDX-5613 in Patients with Relapsed/Refractory Leukemias. Various doses of SNDX-5613 will be investigated.EUCTR2020-004104-34-FRSyndax Pharmaceuticals, Inc333
进行中（未招募）
1 期
A study to investigate the short- and long-term safety and tolerability of the drug SNDX-5613 in Patients with Relapsed/Refractory Leukemias. Various doses of SNDX-5613 will be investigated.Relapsed or Refractory Acute LeukemiasMedDRA version: 20.1Level: LLTClassification code 10024330Term: Leukemia acuteSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-004104-34-DESyndax Pharmaceuticals, Inc333