Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse AML

NCT01496547 | Completed Phase 2

• 1 other identifier: RJH-2011-RefactoryAML-SCT
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Leukemia

Keywords

feasibility, effective and safety; intensive chemotherapy; RIC regimen; refractory or relapse leukemia; allogeneic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  2-year

Secondary Outcomes (3)

• non-relapse mortality

  2-year

• relapse rate

  2-year

• overall survival

  2-year

Study Arms (1)

intensive chemo - RIC preparation

EXPERIMENTAL

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

Interventions

intensive chemo - RIC preparation DRUG

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.

Also known as: FLAG-IDA-RIC

intensive chemo - RIC preparation

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• age less than 18 years or over 61 years
• liver function/renal function damage (over 2 X upper normal range)
• with mental disease

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, 200025, China

Location

Related Publications (1)

• Tang W, Fan X, Wang L, Hu J. Busulfan and fludarabine conditioning regimen given at hematological nadir of cytoreduction fludarabine, cytarabine, and idarubicin chemotherapy in patients with refractory acute myeloid leukemia undergoing allogeneic stem cell transplantation: a single arm pilot consort study. Medicine (Baltimore). 2015 Apr;94(15):e706. doi: 10.1097/MD.0000000000000706.

  PMID: 25881847 DERIVED

Study Officials

• Jiong HU, M.D.

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Blood and Marrow Transplantation Center

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 21, 2011
• Study Start: January 1, 2011
• Primary Completion: February 28, 2018
• Study Completion: June 30, 2018
• Last Updated: March 19, 2019

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)