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Flu-Bu-Mel Based Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allo-HSCT

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04897139
Collaborator
(none)
23
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this phase II clinical trial, we evaluate the efficacy and feasibility of conditioning regimen of fludarabine 150mg/m2, busulfan 9.6mg/kg, melphalan 100mg/m2 and etoposide 800mg/m2 in patients with lymphoid malignancies.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Clinical Trial of Flu-Bu-Mel-E (Fludarabine, Busulfan, Melphalan and Etoposide) as Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment arm

treatment arm

Drug: Flu-Bu-Mel-E
fludarabine 150mg/m2, busulfan 9.6mg/kg, melphalan 100mg/m2 and etoposide 800mg/m2

Outcome Measures

Primary Outcome Measures

  1. disease-free survival [1 year after allo-HSCT]

    event defined as disease progression, relapse or death of any causes

Secondary Outcome Measures

  1. Overall survival [1 year after allo-HSCT]

    event defined as death of any causes

  2. Non relapse morality [1 year after allo-HSCT]

    event defined as death of any causes except for disease progression or relapse

  3. Relapse [1 year after allo-HSCT]

    event defined as disease progression or relapse

  4. GVHD-free or relapse-free survival [1 year after allo-HSCT]

    event defined as disease progression or relapse, death of any cause, grade III-IV aGVHD or moderate to severe cGVHD

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • lymphoid malignancies

  • donor available: HLA matched sibling, unrelated donor or haplo-identical related donor.

  • patients with ECOG <3

Exclusion Criteria:

  • inform consent not provided

  • ECOG >=3

  • poor liver function (enzyme >2N or bilirubin >2N)

  • poor renal function (Scr >2N)

  • poor cardiac function (EF <45%)

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

  • Principal Investigator: Jiong HU, Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiong HU, Head, BMT program, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT04897139
Other Study ID Numbers:
  • RJH-Lym-2021
First Posted:
May 21, 2021
Last Update Posted:
May 26, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of May 26, 2021