Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Disease Progression

Neoplasms by Histologic Type

Hematologic Diseases

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Vosaroxin and Cytarabine

Hamid Sayar, MD

This is a pilot efficacy assessment clinical trial of vosaroxin and cytarabine for the treatment of adults 60 years of age or older with previously untreated acute myeloid leukemia. A total of 17 evaluable patients are planned to be treated on the study.

Primary objective: rate of complete remission (morphologic complete remission or morphologic complete remission with incomplete blood count recovery) Secondary objectives: (1) safety of this combination in induction therapy of older patients previously unexposed to intensive chemotherapy; (2) progression-free survival; (3) length of stay in hospital for induction; (4) 30- and 60-day mortality rate.

The treatment period will include up to 4 cycles of treatment (induction 1, induction 2, consolidation 1, and consolidation 2). In each cycle, the first day of study treatment will be considered day 1.

* Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) \> 1000 cells/L.
* Up to 2 cycles of consolidation treatment may be completed by eligible patients in remission (morphologic complete remission or morphologic complete remission with incomplete blood count recovery) if safety parameters are met.

Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML

Pilot Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML

Percentage of patients who have complete remission as defined by the International Working Group for AML: morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi or CRp)

Number of unique patients who had a procedure or treatment related (possible, probable or definite) adverse events. (graded per NCI CTC v4.0)

Hamid Sayar

Assistant Professor of Clinical Medicine, Hematology/Oncology

Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) \> 1000 cells/L

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Due to the death of 2 patients which raised safety concerns, the study was closed with 2 patients enrolled.

All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit

Rate of Complete Remission

All patients enrolled and received treatment

Procedure or Procedure Related Adverse Events

Overall Study

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Hematinics

Liver Extracts

All participants will be tested for HBsAg by using serum samples. Among those who are positive for HBsAg, further clinical work-ups including AFP test and ultrasonography for liver exam will be performed. Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group.

All subjects in this arm will be followed by linkage to Cancer Register and Population Register.

Biomarker testing and Ultrasonography

Mingfang Ji, MD

All participants in the selected communities will be tested for HBsAg by using serum samples. Among those who are positive for HBsAg, further clinical work-ups including AFP test and ultrasonography for liver exam will be performed. High risk group will be selected according to the definition. HCC diagnosis will be determined according to imaging and/or biopsy result. Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group.

All subjects in the control arm (control communities) will be followed by record linkage to Cancer Register and Population Register.

Sample selection

* Select communities of 70,000 to 120,000 populations in Zhongshan City as the investigators' fields.
* Divide them into screening group and control group according to the areas of administration

Participants recruitment

- Subjects voluntarily attend this screening study

Informed consent - Informed consent forms will be collected at the recruitment.

Questionnaires

- Face-to-face interviews are conducted by well-trained investigators

Serological tests

* Each blood samples will be tested for the surface antigen of the hepatitis B virus (HBsAg).
* Among those who are positive for HBsAg, further clinical work-ups including Alpha-Fetoprotein(AFP) test and ultrasonography for liver exam will be performed and high risk group will be selected according to the definition.
* HCC diagnosis will be determined according to imaging and/or biopsy result.
* The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital.

Follow up

* The cohort will follow up according to the screening protocol. Briefly, Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group.
* All subjects in the control arm (control communities) will be followed by record linkage to Cancer Register and Population Register.

Hepatocellular Cancer (HCC) Screening in Zhongshan City

Searching for Early Detection Biomarkers and to Reduce Mortality Rate of Hepatocellular Cancer (HCC) in Zhongshan City

To reduce 5-year HCC specific mortality rate compare with that of general population

To improve early diagnosis rate of HCC compare with that of general population

To identify early expression markers of HCC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML	NCT02485353	Leukemia, Myelo...	Vosaroxin and C...	60 Years -	Indiana University
Hepatocellular Cancer (HCC) Screening in Zhongshan City	NCT02501980	Liver Neoplasms	Biomarker testi...	35 Years - 64 Years	Zhongshan People's Hospital, Guangdong, China

Spots Global Cancer Trial Database for mortality rate