Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse AML

• Status: Completed
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Fludarabine

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