Study of Standard and Individualized Treatment Model for Relapse and Refractory Lymphatic System Malignant Tumors
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of the study is to research the standard and individualized treatment model for relapse and refractory lymphatic system malignant tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 lymphoma
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 27, 2016
CompletedFirst Posted
Study publicly available on registry
October 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedOctober 12, 2016
October 1, 2016
2.5 years
September 27, 2016
October 10, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
overall response rate
2 years after treatment
complete response
2 years after treatment
progression-free survival
2 years after treatment
overall survival
2 years after treatment
Study Arms (1)
Treatment group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
September 27, 2016
First Posted
October 11, 2016
Study Start
June 1, 2015
Primary Completion
December 1, 2017
Study Completion
March 1, 2018
Last Updated
October 12, 2016
Record last verified: 2016-10