Safety and Efficacy Evaluation of Decitabine With R-GDP

Safety and Efficacy Evaluation of Decitabine With R-GDP on Refractory or Relapsed NHL Patients

Assessment of the Safety and efficacy of Administering decitabin plus R-GDP to NHL patients

Study Overview

• Status: Unknown
• Conditions: NHL
• Intervention / Treatment: Drug: Decitabine and R-GDP

Detailed Description

RR NHL patients will be treated with decitabin plus R-GDP , safety and efficacy will be assessed.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 010
      • Recruiting
      • Peking University Third Hospital
      • Contact: Xinan Lu, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Relapsed or refractory Non-Hodgkin's lymphoma(NHL) patiens.
2. Eastern Cooperative Oncology Group(ECOG) score 0-2
3. Expected survival >3 months
4. Measurable disease.

Exclusion Criteria:

1. Patients who needs treatment with immunosuppressive agents
2. Hematosepsis or Uncontrolled active infection
3. History of epilepsy or other CNS disease.
4. Active hepatitis B , hepatitis C or HIV infection or any other uncontrolled active infection.
5. Pregnancy or breast-feeding women.
6. Any uncontrolled medical disorders that the researchers considered are not suitable to participate the clinical trial.
7. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluatio

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decitabine and R-GDP; ALL patients will be treated with Decitabine and R-GDP	Drug: Decitabine and R-GDP; Decitabine and R-GDP; Other Names: DR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival	2 years

Collaborators and Investigators

• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Investigators: Principal Investigator: Hongmei Jing, MD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Decitabine
• Other Study ID Numbers: M201791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No