Clinical trial · Interventional
Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation for Non-Hodgkin's Lymphoma (NHL)
Open-labelled, Multicenter Phase II Clinical Trial of Intravenous Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation in Patients With Poor-risk, Refractory or Relapsed Non-Hodgkin's Lymphoma
NCT03792815CI-TRIAL-00036357BMEcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- busulfan melphalan etoposide
- description
- 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
- interventionNames
- Drug: Busulfan
- Drug: Melphalan
- Drug: Etoposide
Primary outcomes (1)
- measure
- rate of event free survival
- timeFrame
- from date of ASCT until the the time of disease progression, relapse, or death, whichever came first, assessed at least 2 years
- description
- calculate from the date of ASCT until the time of disease progression, relapse, or death
Secondary outcomes (2)
- measure
- rate of event free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion criteria 1. Histologically confirmed aggressive NHL 2. Mantle cell lymphoma 3. salvage chemotherapy sensitive relapse/refractory NHL 4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2. 5. Age; 18-65 6. Adequate renal function: serum creatinine ≤ 1.5mg/dL 7. Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value \& Bilirubin \< 2 X upper normal value Exclusion criteria 1. low grade NHL 2. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri 3. 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) 4. Pregnant or lactating women, women of childbearing potential not employing adequate contraception 5. HIV (+) 6. 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
References
Publications (0)
Data not yet available
No reference posted for this study.