BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma

NCT03794167 | Completed Phase 2

• 1 other identifier: CISL 12-05
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators developed a protocol comparing busulfan/cyclophosphamide/etoposide (BuCE) and busulfan/melphalan/etoposide (BuME) regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).

Conditions

Non-hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Rate of progression free survival

  calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death Calculate from the date of ASCT (autologous stem cell transplantation) until the time of disease progression, relapse, or death

  2 years

Secondary Outcomes (2)

• Rate of overall survival

  2 years

• Rate of regimen related toxicity

  6 months

Study Arms (2)

busulfan cyclophosphamide etoposide

EXPERIMENTAL

busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6, cyclophosphamide 50mg/kg/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4

Drug: Busulfan; Drug: Cyclophosphamide; Drug: Etoposide

busulfan melphalan etoposide

ACTIVE COMPARATOR

busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6 melphalan 50mg/m2/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4

Drug: Busulfan; Drug: Etoposide; Drug: Melphalan

Interventions

Busulfan DRUG

busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6

Also known as: Busulfex

busulfan cyclophosphamide etoposide; busulfan melphalan etoposide

Cyclophosphamide DRUG

cyclophosphamide 50mg/kg/day i.v. on days -3 and -2

busulfan cyclophosphamide etoposide

Etoposide DRUG

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

busulfan cyclophosphamide etoposide; busulfan melphalan etoposide

Melphalan DRUG

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

Also known as: Alkeran

busulfan melphalan etoposide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed aggressive NHL
• Mantle cell lymphoma
• salvage chemotherapy sensitive relapse/refractory NHL or high risk NHL with remission in induction chemotherapy
• 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 -

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Jong-Ho Won

Seoul, 04401, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Busulfan; Cyclophosphamide; Etoposide; Melphalan

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jong-Ho Won, Professor

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel assignment

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 4, 2019
• Study Start: June 1, 2012
• Primary Completion: May 30, 2017
• Study Completion: November 30, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)