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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Contact:

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:

  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 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
Other: Hematopoietic stem cell transplantation

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

Peking University

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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