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Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse AML

Primary Purpose

Acute Leukemia

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

intensive chemo - RIC preparation

About this trial

This is an interventional treatment trial for Acute Leukemia focused on measuring feasibility, effective and safety, intensive chemotherapy, RIC regimen, refractory or relapse leukemia, allogeneic stem cell transplantation

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Blood & Marrow Transplantation Center, RuiJin Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intensive chemo - RIC preparation

Arm Description

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.

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

non-relapse mortality

relapse rate

overall survival

Full Information

NCT ID

NCT01496547

First Posted

December 19, 2011

Last Updated

March 18, 2019

Sponsor

Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01496547

Brief Title

Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse AML

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

February 28, 2018 (Actual)

Study Completion Date

June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Leukemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intensive chemo - RIC preparation

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

intensive chemo - RIC preparation

Other Intervention Name(s)

FLAG-IDA-RIC

Intervention Description

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.

Primary Outcome Measure Information:

Title

Disease-free survival

Time Frame

2-year

Secondary Outcome Measure Information:

Title

non-relapse mortality

Time Frame

2-year

Title

relapse rate

Time Frame

2-year

Title

overall survival

Time Frame

2-year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiong HU, M.D.

Organizational Affiliation

Shanghai Jiao Tong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Blood & Marrow Transplantation Center, RuiJin Hospital

City

Shanghai

ZIP/Postal Code

200025

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25881847

Citation

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.

Results Reference

derived

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Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse AML

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