- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02929615
Study of Standard and Individualized Treatment Model for Relapse and Refractory Lymphatic System Malignant Tumors
October 10, 2016 updated by: Jun Zhu, Peking University
The purpose of the study is to research the standard and individualized treatment model for relapse and refractory lymphatic system malignant tumors.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhu Jun, archiater
- Phone Number: 010-88196596
- Email: Zhujun@csco.org
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
-
Contact:
- Zhu Jun, archiater
- Phone Number: 010-88196596
- Email: Zhujun@csco.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with relapse and refractory lymphoma and multiple myeloma.
- At least 1 measurable lesions and its size≥15mm.
- Patients ≤65 years,no limitations for both gender.
- ECOG score is 0-1.
- Life expectancy≥3 months.
- LVEF≥ 55%; Peripheral blood: WBC ≥ 3.5×10(9)/L,neutrophil ≥1.5×10(9)/L, PLT≥75×109/L,Hb≥90g/L; Renal function: Cr≤2.0×UNL; Liver function: BIL≤2.0×UNL,ALT/AST≤2.5×UNL;
- Written informed consent are acquired.
Exclusion Criteria:
- Previously received stem cell transplantation.
- Women with pregnant, lactating or not to take contraceptive measures.
- Severe acute infection or suppurative and chronic infection that wound not healing.
- Severe heart failure.
- Suffering from mental disorders and poor compliance.
- Other situations that investigators consider as contra-indication for this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall response rate
Time Frame: 2 years after treatment
|
2 years after treatment
|
complete response
Time Frame: 2 years after treatment
|
2 years after treatment
|
progression-free survival
Time Frame: 2 years after treatment
|
2 years after treatment
|
overall survival
Time Frame: 2 years after treatment
|
2 years after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
March 1, 2018
Study Registration Dates
First Submitted
September 27, 2016
First Submitted That Met QC Criteria
October 7, 2016
First Posted (Estimate)
October 11, 2016
Study Record Updates
Last Update Posted (Estimate)
October 12, 2016
Last Update Submitted That Met QC Criteria
October 10, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- v1.0-20150805
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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