Neoplasms

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Rare Diseases

Neoplasm Metastasis

Leukemia

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasm, Residual

Hematologic Diseases

Neoplasms by Histologic Type

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Analgesics

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Aldesleukin

Interleukin-2

Antineoplastic Agents, Alkylating

Cyclophosphamide + Fludarabine prior to CYNK-001 on Days 0, 7, and 14; CYNK-001 at 3 varying dose levels.

CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.

CYNK-001

Cherie Daly, MD

Michael Maris, MD

Hongtao Liu, MD, PhD

James McCloskey, MD

Eunice Wang, MD

Joseph Jurcic, MD, PhD

Lauren Harrison, MSN

Mitchell Cairo, MD

Amir Steinberg, MD

William Donnellan, MD

Melissa Cabrera, BS

Naveen Pemmaraju, MD

Daniel Egan, MD

This study will find the maximum tolerated dose or the maximum planned dose of CYNK-001 which contains natural killer (NK) cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given after lymphodepleting chemotherapy. The safety of this treatment will be evaluated, and researchers want to learn if NK cells will help in treating acute myeloid leukemia.

Experimental: Minimal Residual Disease (MRD) positive AML patients; Cyclophosphamide + Fludarabine + CYNK-001. On Days 0, 7, and 14, (and 21 in certain arms) CYNK-001 at 3 varying dose levels.

Experimental: Relapsed/Refractory AML patients; Cyclophosphamide + Fludarabine + CYNK-001. On Days 0, 7, and 14, (and 21 at certain dose levels) CYNK-001 at 3 varying dose levels.

Natural Killer Cell (CYNK-001) Infusions in Adults With AML

A Phase I Multi-dose Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) With or Without Recombinant Human Interleukin-2 (rhIL-2) in Adults With Primary or Secondary Acute Myeloid Leukemia (AML) in Morphologic Complete Remission With Minimal Residual Disease (MRD) or Relapsed/Refractory (R/R) AML

The number of participants who experience a DLT will be measured.

The maximum dose safely administered for the treatment of patients with AML.

Frequency and severity of Adverse Events will be evaluated.

The number of participants who convert from MRD positive to MRD negative in the MRD positive arm.

The time it takes to convert from MRD positive to MRD negative in the MRD positive arm.

The measure of how long participants remain MRD negative in the MRD positive arm.

Date of first CYNK-001 infusion to date of disease progression in the MRD positive arm.

Duration from first Morphologic CR observation to time of disease progression in the MRD positive arm.

Date of first CYNK-001 infusion to date of death.

Defined as achievement of Complete Remission (CR), Complete Remission with incomplete (CRi) hematologic recovery, or Morphologic leukemic-free state (MLFS) in the Relapsed/Refractory AML arm.

Duration of best response in the Relapsed/Refractory AML arm.

Celularity Incorporated

Cytarabine

Venetoclax

Mitoxantrone

Azacitidine

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

2 cycles of VCA regimens followed by 2 cycles of D-MAG regimens, and then repeat the above four courses of treatment once

venetoclax combining chidamide and azacitidine (VCA) 28 days per cycle × 2 cycles； 1) chidamide 30mg biw × 2weeks；2) venetoclax 200mg/d × 2 weeks 3) azacitidine 100mg/d d1-7 dicitabine combined with liposome mitoxantrone, cytarabine, and G-CSF (D-MAG) regimen 28 days per cycle ×2 cycles；

1）dicitabine 25mg d1-3，2）liposome mitoxantrone 20mg d4，3）cytarabine 10mg/m2 Q12h d1-7 4）G-CSF 300ug d-1 until WBC \> 20×109/L

Venetoclax Combining Chidamide and Azacitidine (VCA) regimen followed by dicitabine combined with liposome mitoxantrone, cytarabine, and G-CSF (D-MAG) regimen

Bing Xu, M.D.

Zhifeng Li

Bing Xu

The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Elderly Patients with AML have inferior outcomes due to poor physical condition, and intolerant to conventional chemotherapy. The regimen of Venetoclax and Azacitidine has been widely used in these patients and has proved to achieve higher CR rate than low intensity therapy. However, the median duration of response (DOR) of this regimen is about one year. Chidamide is a histone deacetylase (HDAC) inhibitor and preclinical data showed adding low-dose Chidamide to venetoclax could significantly promoted apoptosis of leukemia cell lines. The Venetoclax Combining Chidamide and Azacitidine (VCA) regimen was applied to one 62-year-old male patient with AML who achieved CR. Meanwhile, Liposome mitoxantrone has better safety and tolerance than mitoxantrone in elderly patients. Thus, this study is intended to use 2 cycles of VCA regimens followed by 2 cycles of D-MAG regimens, and then repeat the above four courses of treatment once to improve the median event free survival of elderly AML patients.

VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Venetoclax Combining Chidamide and Azacitidine (VCA) Regimen Followed by Dicitabine Combined With Liposome Mitoxantrone, Cytarabine, and G-CSF (D-MAG) Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) : A Multicenter, Prospective, Single Arm Clinical Trial

Leukemia-free survival (LFS) is defined as survival without evidence of relapse from treatment initiation

Overall survival（OS）is defined as the time from treatment initiation to death from any cause.

Adverse event is defined as any untoward medical occurrence associated with treatment

ORR is defined as CR, CRi and PR. Partial remission (PR) is defined as a decrease of at least 50% in the percentage of blasts to 5 to 25% in the bone marrow aspirate and the normalization of blood counts.

Chipscreen Biosciences, Ltd.

CSPC Pharmaceutical Group Limited

Fujian Provincial Hospital

Fujian Cancer Hospital

Zhangzhou manicipal hospital of Fujian Province

Jieyang People's Hospital

Huizhou Municipal Central Hospital

The First Affiliated Hospital of Xiamen University

Syndrome

IDH305 + Standard of care for patients that are medically fit for induction.

IDH305 + Standard of care for patients that are medically unfit for induction.

IDH305

Novartis Pharmaceuticals

The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML).

A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

A Phase I, Open Label, Multicenter, Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

To characterize the PK profile of IDH305 with SOC medications (each Arm)

To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)

Sarcoma

Soft Tissue Sarcoma

Amino Acids

Daunorubicin

Idarubicin

Quizartinib

Anti-Bacterial Agents

Antibiotics, Antitubercular

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by the experimental drug quizartinib

Consolidation: up to 4 cycles of cytarabine followed by the experimental drug quizartinib and/or hematopoeitic stem cell transplant

Continuation: up to 36 cycles with the experimental drug quizartinib

Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by placebo

Consolidation: up to 4 cycles of cytarabine followed by placebo and/or hematopoeitic stem cell transplant

Continuation: up to 36 cycles with placebo

Chemotherapy

Placebo

Global Clinical Leader

Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.

Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML).

Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.

This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of this study is to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as continuation therapy for up to 36 cycles) on overall survival in subjects with FLT3-internal tandem duplication (ITD) positive AML.

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)

A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Overall survival is defined as the time from randomization until death from any cause.

Event-free survival (EFS) is the time from randomization to the earliest date of either refractory disease (or treatment failure \[TF\]), relapse, or death from any cause. Refractory disease is defined as complete remission never achieved during Induction (CR: \>1000 neutrophils, \>100,000 platelets, \<5% blasts, and other \[defined as absence of extramedullary disease \[EMD\], blasts with rods, and leukemic blasts\]). For refractory disease, EFS event date is Day 1 (randomization). Relapse after CR is defined as ≥5% blasts, leukemic blasts, extramedullary leukemia, and presence of rods. This analysis is based on a response assessment with TF defined as not achieving response of CR, using a 42- day window from the start of the last cycle in Induction for CR evaluation.

Complete remission (CR) rate is defined as the percentage of participants achieving CR, defined as a disappearance of all target lesions, after Induction.

Composite complete remission (CRc) rate is defined as the percentage of participants whose best response is complete remission (CR), defined as a disappearance of all target lesions, or CR with incomplete neutrophil or platelet recovery (CRi) at the end of first Induction cycle.

A treatment-emergent adverse event (TEAE) is defined as an adverse event that occur, having been absent before first dose of quizartinib or placebo, or have worsened in severity after initiating quizartinib or placebo. Adverse events collected more than 30 days after the last dose of quizartinib/placebo will not be considered TEAEs unless they are considered drug-related.

Complete remission (CR) is defined as participants achieving CR defined as a disappearance of all target lesions. Minimal or measurable residual disease is the presence of a small number of leukemic cells in the bone marrow of patients with AML below the level of detection using conventional morphologic assessment.

Composite complete remission (CRc) is defined as participants achieving complete remission (CR), defined as a disappearance of all target lesions, or CR with incomplete neutrophil or platelet recovery (CRi). Minimal or measurable residual disease is the presence of a small number of leukemic cells in the bone marrow of patients with AML below the level of detection using conventional morphologic assessment.

AUCss was assessed by population PK analysis during Cycle 1 of each phase.

Css,max was assessed by population PK analysis during Cycle 1 of each phase.

Tmax,ss was assessed by population PK analysis during Cycle 1 of each phase.

Daiichi Sankyo

Participants who were randomized to receive quizartinib treatment regimen.

Participants who were randomized to receive placebo treatment regimen.

Participants who were randomized to receive the quizartinib treatment regimen.

Total

Age, Continuous

<60 years

≥60 years

Age, Customized

Sex: Female, Male

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

Other

Unknown or Not Reported

Race/Ethnicity, Customized

Singapore

United States

Czechia

Portugal

Russia

South Korea

China

Brazil

Poland

Bulgaria

France

Serbia

Croatia

Romania

Hungary

Japan

Ukraine

United Kingdom

Spain

Canada

Belgium

Taiwan

Italy

Israel

Australia

Germany

Region of Enrollment

Demographic and baseline characteristics were assessed in the Intent-to-Treat Analysis Set.

Contact for Clinical Trial Information

Overall survival was assessed in the Intent-to-Treat Analysis Set.

Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Event-free survival was assessed in the Intent-to-Treat Analysis Set.

Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Complete remission was assessed in the Intent-to-Treat Analysis Set.

Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Composite complete remission (CRc) rate was assessed in the Intent-to-Treat Analysis Set.

Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Any TEAE

Gastrointestinal disorders

Diarrhoea

Nausea

Vomiting

Stomatitis

Constipation

Abdominal pain

Dyspepsia

Abdominal pain upper

Infections and infestations

Pneumonia

Sepsis

General disorders and administration site disorders

Treatment-emergent adverse events were assessed in the Safety Analysis Set.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Natural Killer Cell (CYNK-001) Infusions in Adults With AML	NCT04310592	Leukemia Leukemia, Myelo... Leukemia, Myelo... Neoplasms by Hi... Neoplasms Immunosuppressi... Immunologic Fac... Physiological E... Alkylating Agen... Antimetabolites... Antiviral Agent... Analgesics, Non... Anti-infective ... Analgesics Peripheral Nerv... Hematologic Dis... Hematologic Neo... Leukemia in Rem... Relapsed Adult ... Refractory AML	CYNK-001	18 Years - 80 Years	Celularity Incorporated
VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)	NCT05603884	Leukemia, Myelo... AML Stage, Adul...	Venetoclax Comb...	60 Years -	The First Affiliated Hospital of Xiamen University
A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia	NCT02826642	Acute Myeloid L...	IDH305	18 Years -	Novartis
VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)	NCT05603884	Leukemia, Myelo... AML Stage, Adul...	Venetoclax Comb...	60 Years -	The First Affiliated Hospital of Xiamen University
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)	NCT02668653	Acute Myeloid L... Leukemia	Chemotherapy Quizartinib Placebo	18 Years - 75 Years	Daiichi Sankyo
A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia	NCT02826642	Acute Myeloid L...	IDH305	18 Years -	Novartis
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)	NCT02668653	Acute Myeloid L... Leukemia	Chemotherapy Quizartinib Placebo	18 Years - 75 Years	Daiichi Sankyo
Natural Killer Cell (CYNK-001) Infusions in Adults With AML	NCT04310592	Leukemia Leukemia, Myelo... Leukemia, Myelo... Neoplasms by Hi... Neoplasms Immunosuppressi... Immunologic Fac... Physiological E... Alkylating Agen... Antimetabolites... Antiviral Agent... Analgesics, Non... Anti-infective ... Analgesics Peripheral Nerv... Hematologic Dis... Hematologic Neo... Leukemia in Rem... Relapsed Adult ... Refractory AML	CYNK-001	18 Years - 80 Years	Celularity Incorporated

Spots Global Cancer Trial Database for newly diagnosed acute myeloid leukemia