CLAGE Sequential With Flu-Bu Conditioning for Refractory Acute Leukemia

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03882203
Collaborator
(none)
18
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Study Details

Study Description

Brief Summary

For patients with refractory acute leukemia, allogeneic stem cell transplantation is the only curative therapy. Only 20% of patients may achieve long-term survival mostly due to relapse or nor-relapse mortality (NRM). In previous study, we demonstrated that intensive leukemia debulking chemotherapy FLAG-IDA sequential with Flu-BU conditioning is feasible with ~40% long-term survival. In the study, we further modified the chemotherapy with cladribine replacing fludarabine aiming a more potent anti-leukemia effect. Meanwhile, we reduce the dose of busulfan for patients with poor performance status and age over 45 aim to reduce the NRM. All patients will also receive post-transplantation maintenance therapy with low-dose decitabine to prevent relapse.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

For patients with refractory acute leukemia, allogeneic stem cell transplantation is the only curative therapy. Only 20% of patients may achieve long-term survival mostly due to relapse or nor-relapse mortality (NRM). In previous study, we demonstrated that intensive leukemia debulking chemotherapy FLAG-IDA sequential with Flu-BU conditioning is feasible with ~40% long-term survival. The most important cause of treatment failures were relapse and non-relpase mortality. The further analysis demonstrated that patients with higher bone marrow blast before allo-HSCT was associated with treatment failure and patients with poor perforce status or age over 45 had increased rate of NRM. To further optimization the protocol, we modified the chemotherapy with cladribine replacing fludarabine aiming a more potent anti-leukemia effect and replace idarubicin with VP-16. All patients will also receive post-transplantation maintenance therapy with low-dose decitabine (5mg/m2 daily for 5 days) to prevent the further reduce the relapse incidence. We anticipate LFS at 1 year should be above 50% and 1-year LFS of 20% is considered unacceptable.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cladribine With Intermediate Cytarabine, G-CSF and VP16 Sequential With Fludarabine and Busulifan as Condoning Regimen for Refractory Acute Leukemia
Actual Study Start Date :
Aug 1, 2018
Actual Primary Completion Date :
Aug 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment

Patients receive the study protocol: CLAGE sequential with Flu-Bu as conditioning regimen followed by low-dose decitabine maintenance

Drug: CLAGE-FluBu
Cladribine combined with cytarabine and VP16 sequential with Fludarabine combined with busulifan

Outcome Measures

Primary Outcome Measures

  1. leukemia-free survival [1 year]

    From enrollment to any event as relapse or death

Secondary Outcome Measures

  1. overall survival [1 year]

    From enrollment to death

  2. relapse rate [1 year]

    From enrollment to documentation of relapse

  3. non relapse mortality [1 year]

    From enrollment to documentation of death without evidence of leukemia

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • refractory myeloid malignancies including acute myeloid leukemia (AML) or chronic myeloid leukemia in blastic crisis (CML-BC)

  • HLA matched sibling,unrelated donor, or haplo-identical donor

  • Patients with bone marrow blast >5% and positive measurable disease via flowcytometry or PCR.

Exclusion Criteria:
  • patients with active infection

  • liver function damage: ALT/AST above 2X normal range; and renal function damage Scr>160µmol/L; insufficient pulmonary function (FEV1,FVC,DLCO<50%)and heart failure or with EF <50%

  • mental instability

  • unwilling to give inform consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Blood & Marrow Transplantation Center, RuiJin Hospital Shanghai China 200025

Sponsors and Collaborators

  • Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Junming Li, M.D, Department of Hematology, Rui Jin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiong HU, Head, Blood & Marrow Transplantation program, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT03882203
Other Study ID Numbers:
  • RJH-Ref-AL-2018
First Posted:
Mar 20, 2019
Last Update Posted:
Nov 26, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 26, 2021