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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02929615
Recruitment Status : Unknown
Verified October 2016 by Jun Zhu, Peking University.
Recruitment status was:  Recruiting
First Posted : October 11, 2016
Last Update Posted : October 12, 2016
Information provided by (Responsible Party):
Jun Zhu, Peking University

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

Condition or disease Intervention/treatment Phase
Lymphoma Other: Hematopoietic stem cell transplantation Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment group Other: Hematopoietic stem cell transplantation

Primary Outcome Measures :
  1. overall response rate [ Time Frame: 2 years after treatment ]
  2. complete response [ Time Frame: 2 years after treatment ]
  3. progression-free survival [ Time Frame: 2 years after treatment ]
  4. overall survival [ Time Frame: 2 years after treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02929615

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Contact: Zhu Jun, archiater 010-88196596

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China, Beijing
Beijing, Beijing, China, 100142
Contact: Zhu Jun, archiater    010-88196596   
Sponsors and Collaborators
Peking University
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Responsible Party: Jun Zhu, Director, Peking University Identifier: NCT02929615    
Other Study ID Numbers: v1.0-20150805
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016