Study of New RIC Regimen of BuFlu in Older and/or Intolerable Patients

April 9, 2013 updated by: FENGRONG WANG, Peking University People's Hospital

The Study of New RIC Regimen of BuFlu in Older or Intolerable Patients With Hematologic Malignant Diseases

The purpose of this study is to determine whether the new RIC regimen, containing of low dose of Bu (9.6mg/kg)and fludarabine without ATG, is suitable and effective in treating aged and/or intolerable patients with hematologic malignant disease, who undergoes allogenic stem cell transplantation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

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, China, 100044
        • Peking University People's Hospital

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

55 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population is patients with hematologic malignant diseases, who will undergo HLA matched HSCT.

Description

Inclusion Criteria:

  • diagnosed of hematologic malignant disease
  • will undergo HLA matced HSCT
  • age >=55years
  • <55year and intolerable to standard myeloablative conditioning

Exclusion Criteria:

  • KPS status <70
  • cardiac EF<50%
  • creatine clearance <50 ml/min
  • ALT more than 10 times of upper normal limit

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
modified BuFlu, HSCT, elder/intolerable
The study group is the hematlogic malignant patients that older than 55years and/or with severe concurrent medical conditions, who will undergo HLA-matced allogenic HSCT to cure the disease. The patients will received a modified BuFlu conditioning.
Procedure: modified BuFlu conditioning
The regimen consisted of hydroxyurea 80 mg/kg on d -10; cytorabine 2 g/m2 on d -9; busulfan 3.2mg/kg/day iv. ×3days( on d -8 to -6); Flu30mg/m^2 i.v.×5days(on d-6 to-2) and semustine 250 mg/m2 on d -3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stem cell engraftment
Time Frame: 30day post transplantation
30day post transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
toxicity and treatment related mortality
Time Frame: 100day and 1 year post transplantation
100day and 1 year post transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: XiaoJun Huang, MD, Peking University People's Hospital, Department of Hematology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

April 7, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (ESTIMATE)

April 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUIH-201303

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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