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HD-Idarubicin/Etoposide Intensified Conditioning Regimen Allo-HSCT for Adult ALL

NCT01873807 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-10-09

No results posted yet for this study

Summary

Intensified conditioning regimen allo-HSCT is based on a hypothesis of that intensifying condition with less-used drugs could overcome resistance,reduce tumor burden, and most importantly, spare enough time for slow-growing GVL effect following immune reconstitution to finally get rid of MRD and control the disease. Our previous trial of HDE-ALL-2011 (NCT01457040) have confirmed the role of intensified conditioning allo-HSCT in adult ALL, resulting in significantly improved OS and EFS in comparison with previous standard TBI/CY2 conditioning regimen(data not yet published). But at the same time, FA-TBI/CY2-VP16 conditioning regimen was associated with high transplantation-related mortality (TRM), which might be attributed to excessive suppression on both bone marrow and immune. TT-ALL-HIE-2013, substituting FA with idarubicin, is aimed at maintaining anti-tumor effect with less cross-resistance and immune suppression and reducing TRM.

Conditions

Interventions

DRUG

IDA

Idarubicin: 15mg/m2/d: -8-\>-6d

RADIATION

TBI

TBI: 4.5 Gy/d, -5d, -4d

DRUG

CTX

CY:60mg/kg/d, -3d, -2d

DRUG

VP-16

VP-16: 15mg/kg, -2d, -1d

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Qifa Liu, MD · Department of Hematologym, Nanfang Hospital, Southern Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01873807 on ClinicalTrials.gov