NCT04897139

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

3.4 years

First QC Date

May 19, 2021

Last Update Submit

October 21, 2023

Conditions

Lymphoid Neoplasm

Outcome Measures

Primary Outcomes (1)

  • disease-free survival

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

    1 year after allo-HSCT

Secondary Outcomes (4)

  • Overall survival

    1 year after allo-HSCT

  • Non relapse morality

    1 year after allo-HSCT

  • Relapse

    1 year after allo-HSCT

  • GVHD-free or relapse-free survival

    1 year after allo-HSCT

Study Arms (1)

treatment arm

EXPERIMENTAL

treatment arm

Drug: Flu-Bu-Mel-E

Interventions

Flu-Bu-Mel-EDRUG

Fludarabine 150mg/m2, busulfan 6.4mg/kg, melphalan 100mg/m2 and etoposide 600mg/m2

treatment arm

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • lymphoid malignancies
  • donor available: HLA matched sibling, unrelated donor or haplo-identical related donor.
  • patients with ECOG \<3

You may not qualify if:

  • inform consent not provided
  • ECOG \>=3
  • poor liver function (enzyme \>2N or bilirubin \>2N)
  • poor renal function (Scr \>2N)
  • poor cardiac function (EF \<45%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, 200025, China

RECRUITING

Study Officials

  • Jiong HU

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiong Hu

CONTACT

86-21-64370045hj10709@rjh.com.cn

Jieling Jiang

CONTACT

86-21-64370045jjl12223@rjh.com.cn

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, BMT program, Rui Jin Hospital

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 21, 2021

Study Start

January 1, 2021

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

CN(1)