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Seuqential Intensive Chemotherapy Followed by Allogeneic Stem Cell Transplantation With Reduce-intensity Conditioning for Refractory and Relapse Acute Leukemia in Adult Patients


Phase 2
16 Years
55 Years
Open (Enrolling)
Both
Acute Leukemia

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Trial Information

Seuqential Intensive Chemotherapy Followed by Allogeneic Stem Cell Transplantation With Reduce-intensity Conditioning for Refractory and Relapse Acute Leukemia in Adult Patients


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

2-year

Safety Issue:

Yes

Principal Investigator

Jiong HU, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai JiaoTong University

Authority:

China: Ethics Committee

Study ID:

RJH-2011-RefactoryAL-SCT

NCT ID:

NCT01496547

Start Date:

November 2011

Completion Date:

December 2014

Related Keywords:

  • Acute Leukemia
  • feasibility, effective and safety
  • intensive chemotherapy
  • RIC regimen
  • refractory or relapse leukemia
  • allogeneic stem cel ltransplantation
  • Leukemia
  • Acute Disease

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