A Clinical Trial Evaluating the Efficacy of Ultra Low Dose of Decitabine in Myelodysplastic Syndromes (MDS)

NCT ID: NCT02779569

Last Updated: 2017-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-08-31

Brief Summary

To evaluate the safety and clinical efficacy of ultra-low-dose decitabine in Chinese MDS

Detailed Description

To develop a highly effective and safe protocol, a multi-center, prospective clinical trial was conducted in China, with aims to evaluate the grade III and IV hematologic toxicity and clinical efficacy of subcutaneous injection of ultra-low-dose decitabine (5 to 7 mg/m2) for treatment of myelodysplastic syndrome (MDS), while decitabine at a dose of 20 mg/m2 as a control.

Conditions

Myelodysplastic Syndromes (MDS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultra-low-dose group

decitabine was subcutaneously administered at 5 to 7 mg/m2 once daily for successive 3 days at the first week, and once daily at weeks 2 to 4, with a total dose of 60 mg in a 4-week cycle.

Group Type: EXPERIMENTAL

decitabine

Intervention Type: DRUG

Low-dose group

decitabine was subcutaneously given at 20 mg/m2 once daily for successive 3 days, with a total dose of 60 mg/m2 in a 4-week cycle.

Group Type: ACTIVE_COMPARATOR

decitabine

Intervention Type: DRUG

Interventions

decitabine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Men or women aged 18 to 80 years;

2. Patients at high risk of MDS assessed by International Prostate Symptom Score (IPSS);

3. Chronic myelomonocytic leukemia (CMML) patients with abnormal white blood cell counts, extremely low platelet count or organ infiltration (such as hepatomegaly, splenomegaly) that required therapy;

4. Patients at low risk of MDS identified by IPSS score who had secondary MDS, platelet count of < 20*10^9/L, no response to erythropoietin (EPO) (non-5q deletion syndrome) in the presence of disease symptoms or blood transfusion dependence, or no response to EPO/lenalidomide (5q deletion syndrome) in the presence of disease symptoms or blood transfusion dependence;

5. Patients with a Eastern Cooperative Oncology Group (ECOG) of 0 to 2;

6. Patients with an expected lifespan of over 6 months;

7. Patients with a aspartate aminotransferase (AST) of < 2.5 times higher than the normal upper limit, alanine aminotransferase (ALT) of < 2.5 times higher than the normal upper limit, total bilirubin of < 1.5 times higher than the normal upper limit, and serum creatinine of < 1.5 times higher than the normal upper limit;

8. Subjects who had recovery of toxicity, did not undergo any therapy 4 weeks prior to the first trial, and did not receive nitrosourea therapy and bone marrow transplantation 6 weeks prior to the first trial;

9. Female subjects were menopausal, underwent surgical sterilization, or had effective contraception (oral contraceptive, injectable contraceptive, intrauterine device, contraceptive patch, male sterilization) prior to enrollment and during the trial, and were negative for serum or urine pregnancy test at screening;

10. No insemination was given to male subjects during the treatment and within 2 months post-treatment;

11. Subjects complying with the study protocol;

12. Subjects that signed the informed consent, which indicated they understood the purpose, the procedure and potential benefits of the trial and were willing to participate in the trial.

Exclusion Criteria

1. Patients that were diagnosed as acute myeloid leukemia (primitive bone marrow cell proportion of 20% or higher) or other progressive malignant diseases;

2. Patients that received treatment with other drugs within 30 days prior to the first administration of decitabine;

3. Patients that received radiotherapy within 14 days prior to the first administration of decitabine;

4. Patients with uncontrolled heart disease or congestive heart failure;

5. Patients with uncontrolled restrictive or obstructive pulmonary disease;

6. Patients with active viral, bacterial or invasive fungal infections;

7. Patients that were complicated by autoimmune hemolytic anemia or immune thrombocytopenia;

8. Patients with a history of use of azacitidine or decitabine;

9. Patients that were sero-positive for HIV;

10. Patients with mental or other disorders that cannot completely cooperate with the treatment or follow up;

11. Patients bone marrow cannot be sampled;

12. Subjects that were allergic to decitabine vehicle;

13. Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guangsheng He

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

No.303 Hospital of Chinese People's Liberation Army

Nanning, Guangxi, China

Site Status: NOT_YET_RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Shengjing Hospital of China Medical Univercity

Shenyang, Liaoning, China

Site Status: RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Site Status: NOT_YET_RECRUITING

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

Site Status: NOT_YET_RECRUITING

Zhejiang Provincial Hospital of TCM

Hangzhou, Zhejiang, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Guangsheng He, MD.PhD

Role: CONTACT

Phone: 008615312052789

Email: heguangsheng@medmail.com.cn

Facility Contacts

Xiaolin Yin

Role: primary

Guangsheng He

Role: primary

Wei Yang

Role: primary

Mei Zhang

Role: primary

Xiaomin Wang

Role: primary

Jianping Shen

Role: primary

Other Identifiers

ChiCTR-IPR-16008100

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MDS-ULD-2016

Identifier Type: -

Identifier Source: org_study_id