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Seuqential Intensive Chemotherapy Followed by Reduce-intensity Conditioning for Refractory and Relapse Acute Leukemia

This study is currently recruiting participants.
Verified December 2011 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01496547
First received: December 19, 2011
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  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 apporach may not be able to overcome the refractory disease. A new strategy to combined a low dose regimen folloing 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 stratgey for this particular high-risk patients.


Condition Intervention Phase
Acute Leukemia
 Drug: intensive chemotherapy followed by reduced intensity regimen
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Seuqential Intensive Chemotherapy Followed by Allogeneic Stem Cell Transplantation With Reduce-intensity Conditioning for Refractory and Relapse Acute Leukemia in Adult Patients

Resource links provided by NLM:

MedlinePlus related topics: Leukemia
U.S. FDA Resources

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

Primary Outcome Measures:
  • overall survival [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • non-relapse mortality [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
  • relapse rate [ Time Frame: 2-year ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intensive chemo - RIC preparation Drug: intensive chemotherapy followed by reduced intensity regimen
The intensive chemotherapy is composed of high-dose cytarabine 2g/m2 D1-4 + Mitoxantrone (10mg/m2) or idarubicin (12mg/m2) D3-5. The reduced intensity preparation regimen will start 10 days after the chemotherapy with fludarabine 35mg/m2 for 5 days + iv busulfan 3.2mg/kg/day for 2 to 3 days followed by stem cell infusion 2 days later.

  Eligibility

Ages Eligible for Study:   16 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients with refractory or relapse acute leukemia not in remission after 2 cecles of induction chemotherapy early relapse (ist remission less than 6 months) not in remission after 1 cycle of reinduction chgemotherapy multipel relapse patient with very high-risk cytogenetics in any remission
  • age 18-55 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 56 years
  • HLA mismatched related donor
  • liver function/renal function damage (over 2 X upper normal range)
  • with mental disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 JiaoTong University
  More Information

No publications provided

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-RefactoryAL-SCT
Study First Received: December 19, 2011
Last Updated: December 20, 2011
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Leukemia
Acute Disease
Neoplasms by Histologic Type
 Neoplasms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013