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Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse AML

This study is currently recruiting participants.
Verified May 2016 by Jiong HU, Shanghai Jiao Tong University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496547
First Posted: December 21, 2011
Last Update Posted: May 10, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine
  Purpose
Patients with refractory and relapse leukemia had poor outcome even with allogeneic stem cell transplantation. In our previous retrospective study, the overall survival is 14.6+/-8.8% while 90% patients eventually relapsed with marrow ablative conditioning mostly standard iv-Bu-Cy or Cy-TBI. The accumulated TRM is 29.5+/-11.5%. Thus our data suggested that the conventional transplantation approach may not be able to overcome the refractory disease. A new strategy to combined a low dose regimen following intensive chemotherapy for tumor reduction seems to be effect in both relapsed. high-risk and refractory AML or ALL. In this study, we focus on a new treatment strategy for particular refractory AML patients.

Condition Intervention Phase
Acute Leukemia Drug: intensive chemo - RIC preparation Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequential Intensive Chemotherapy Followed by Allogeneic Stem Cell Transplantation With Reduce-intensity Conditioning for Refractory and Relapse Acute Myeloid Leukemia in Adult Patients

Resource links provided by NLM:


Further study details as provided by Jiong HU, Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 2-year ]

Secondary Outcome Measures:
  • non-relapse mortality [ Time Frame: 2-year ]
  • relapse rate [ Time Frame: 2-year ]
  • overall survival [ Time Frame: 2-year ]

Estimated Enrollment: 42
Study Start Date: January 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intensive chemo - RIC preparation
The intensive chemotherapy is composed of Fludarabine 35mg/m2 D1-5, high-dose cytarabine 2g/m2 D1-5 + idarubicin (12mg/m2) D5-7. The reduced intensity preparation regimen will start 7 days after the chemotherapy with fludarabine 35mg/m2 for 5 days + iv busulfan 3.2mg/kg/day for 3 days followed by stem cell infusion 2 days later.
Drug: intensive chemo - RIC preparation
The intensive chemotherapy is composed of fludarabine 35mg/m2 + high-dose cytarabine 2g/m2 D1-5 + idarubicin (12mg/m2) D5-7. The reduced intensity preparation regimen will start 7 days after the chemotherapy with fludarabine 35mg/m2 for 5 days + iv busulfan 3.2mg/kg/day for 3 days followed by stem cell infusion 2 days later.
Other Name: FLAG-IDA-RIC

Detailed Description:
This is a single arm phase II trial to test the efficacy and feasibility of new sequential intensive chemo and transplantation approach for refractory leukemia. Patients with refractory acute myeloid or lymphoblastic leukemia are enrolled in this trial. Patients will received intensive chemotherapy including Fludarabine, cytarabine and idarubicin as (FLAG-IDA). Seven days after the chemotherapy, sequential transplantation conditioning regimen as fludarabine and busulfan will be given.
  Eligibility

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients with refractory or relapse acute myeloid leukemia not in remission after 2 cycles of induction chemotherapy early relapse (1st remission less than 6 months) not in remission after 1 cycle of re-induction chemotherapy multiple relapse
  • age 16-60 years
  • with inform consent
  • no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
  • HLA matched related (6/6) or unrelated donors (at least 8/10)

Exclusion Criteria:

  • age less than 18 years or over 61 years
  • liver function/renal function damage (over 2 X upper normal range)
  • with mental disease
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01496547


Contacts
Contact: Jiong HU, M.D. 86-21-64370045-601818 hujiong@medmail.com.cn

Locations
China
Blood & Marrow Transplantation Center, RuiJin Hospital Recruiting
Shanghai, China, 200025
Contact: Jiong HU, M.D.         
Principal Investigator: Ling Wang, M.D.         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Jiong HU, M.D. Shanghai Jiao Tong University School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jiong HU, Head, Blood and Marrow Transplantation Center, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01496547     History of Changes
Other Study ID Numbers: RJH-2011-RefactoryAML-SCT
First Submitted: December 19, 2011
First Posted: December 21, 2011
Last Update Posted: May 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jiong HU, Shanghai Jiao Tong University School of Medicine:
feasibility, effective and safety
intensive chemotherapy
RIC regimen
refractory or relapse leukemia
allogeneic stem cell transplantation

Additional relevant MeSH terms:
Leukemia
Recurrence
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Fludarabine
Antineoplastic Agents