Study of Standard and Individualized Treatment Model for Relapse and Refractory Lymphatic System Malignant Tumors

Lymphoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02929615
• Other study ID #: v1.0-20150805
• Status: Recruiting
• Phase: Phase 4
• First received: September 27, 2016
• Last updated: October 10, 2016
• Start date: June 2015
• Est. completion date: March 2018

Study information

• Verified date: October 2016
• Source: Peking University
• Contact: Zhu Jun, archiater
• Phone: 010-88196596
• Email: Zhujun[@]csco.org
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to research the standard and individualized treatment model for relapse and refractory lymphatic system malignant tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

Inclusion Criteria:

1. Patients with relapse and refractory lymphoma and multiple myeloma.

2. At least 1 measurable lesions and its size=15mm.

3. Patients =65 years,no limitations for both gender.

4. ECOG score is 0-1.

5. Life expectancy=3 months.

6. 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;

7. Written informed consent are acquired.

Exclusion Criteria:

1. Previously received stem cell transplantation.

2. Women with pregnant, lactating or not to take contraceptive measures.

3. Severe acute infection or suppurative and chronic infection that wound not healing.

4. Severe heart failure.

5. Suffering from mental disorders and poor compliance.

6. Other situations that investigators consider as contra-indication for this study.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Other:
• Hematopoietic stem cell transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate		2 years after treatment	No
Primary	complete response		2 years after treatment	No
Primary	progression-free survival		2 years after treatment	No
Primary	overall survival		2 years after treatment	No