NCT03792815

Brief Summary

The investigators developed a protocol utilizing once-daily intravenous busulfan/melphalan/etoposide regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
5.3 years until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

February 16, 2010

Last Update Submit

January 2, 2019

Conditions

Non-Hodgkin's Lymphoma

Keywords

Transplantation Conditioning

Outcome Measures

Primary Outcomes (1)

  • rate of event free survival

    calculate from the date of ASCT until the time of disease progression, relapse, or death

    from date of ASCT until the the time of disease progression, relapse, or death, whichever came first, assessed at least 2 years

Secondary Outcomes (2)

  • rate of event free survival

    at least 2 years

  • rate of regimen related toxicity

    up to 6 months

Study Arms (1)

busulfan melphalan etoposide

EXPERIMENTAL

busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2

Drug: BusulfanDrug: MelphalanDrug: Etoposide

Interventions

BusulfanDRUG

busulfan 3.2mg/kg iv on day -8, -7, and -6,

Also known as: Busulfex
busulfan melphalan etoposide
MelphalanDRUG

melphalan 50mg/m2/day i.v. on day -3 and -2

Also known as: Alkeran
busulfan melphalan etoposide
EtoposideDRUG

etoposide 400 mg/m2 i.v. on day -5 and -4

busulfan melphalan etoposide

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed aggressive NHL
  • Mantle cell lymphoma
  • salvage chemotherapy sensitive relapse/refractory NHL
  • Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.
  • Age; 18-65
  • Adequate renal function: serum creatinine ≤ 1.5mg/dL
  • Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value \& Bilirubin \< 2 X upper normal value

You may not qualify if:

  • low grade NHL
  • Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
  • Other serious illness or medical conditions
  • Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
  • History of significant neurological or psychiatric disorders
  • Active uncontrolled infection (viral, bacterial or fungal infection)
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  • HIV (+)
  • Patients who have hepatitis B virus (HBV) (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soonchunhyang University Hospital

Seoul, 140-743, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

BusulfanMelphalanEtoposide

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Jong-Ho Won, Professor

    Soonchunhyang University Hospital

    PRINCIPAL INVESTIGATOR

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
professor

Study Record Dates

First Submitted

February 16, 2010

First Posted

January 3, 2019

Study Start

October 1, 2009

Primary Completion

November 1, 2011

Study Completion

September 1, 2013

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

KR(1)