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

NCT02779569 | Unknown

• 2 other identifiers: MDS-ULD-2016ChiCTR-IPR-16008100
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Myelodysplastic Syndromes (MDS)

Outcome Measures

Primary Outcomes (1)

• Grade III and IV hematologic toxicity, according to National Cancer Institute common toxicity criteria (NCI-CTC) V3.0 criteria

  8 months

Secondary Outcomes (9)

• Complete response, according to International Working Group (IWG) response criteria

  8 months

• Complete response (CR) rate of bone marrow, according to IWG response criteria

  8 months

• Partial response (PR) rate, according to IWG response criteria

  8 months

• Hematologic improvement (HI), according to IWG response criteria

  8 months

• Overall response rate, defined as CR＋PR＋HI, according to IWG response criteria

  8 months

Study Arms (2)

Ultra-low-dose group

EXPERIMENTAL

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.

Drug: decitabine

Low-dose group

ACTIVE COMPARATOR

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.

Drug: decitabine

Interventions

decitabine DRUG

Low-dose group; Ultra-low-dose group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 18 to 80 years;
• Patients at high risk of MDS assessed by International Prostate Symptom Score (IPSS);
• 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;
• 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;
• Patients with a Eastern Cooperative Oncology Group (ECOG) of 0 to 2;
• Patients with an expected lifespan of over 6 months;
• 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;
• 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;
• 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;
• No insemination was given to male subjects during the treatment and within 2 months post-treatment;
• Subjects complying with the study protocol;
• 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.

You may not qualify if:

• Patients that were diagnosed as acute myeloid leukemia (primitive bone marrow cell proportion of 20% or higher) or other progressive malignant diseases;
• Patients that received treatment with other drugs within 30 days prior to the first administration of decitabine;
• Patients that received radiotherapy within 14 days prior to the first administration of decitabine;
• Patients with uncontrolled heart disease or congestive heart failure;
• Patients with uncontrolled restrictive or obstructive pulmonary disease;
• Patients with active viral, bacterial or invasive fungal infections;
• Patients that were complicated by autoimmune hemolytic anemia or immune thrombocytopenia;
• Patients with a history of use of azacitidine or decitabine;
• Patients that were sero-positive for HIV;
• Patients with mental or other disorders that cannot completely cooperate with the treatment or follow up;
• Patients bone marrow cannot be sampled;
• Subjects that were allergic to decitabine vehicle;
• Pregnant or lactating women.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (6)

No.303 Hospital of Chinese People's Liberation Army

Nanning, Guangxi, 530021, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Shengjing Hospital of China Medical Univercity

Shenyang, Liaoning, 110022, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

NOT YET RECRUITING

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830001, China

NOT YET RECRUITING

Zhejiang Provincial Hospital of TCM

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Guangsheng He

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangsheng He, MD.PhD

CONTACT

008615312052789; heguangsheng@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 20, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: August 1, 2019
• Last Updated: November 8, 2017

Record last verified: 2016-05

Locations

CN (6)