A Multi-center, Phase 2, Single-Arm, Open-Label Exploratory Study of Individually- Optimized Conditioning Using Pharmacokinetics [PK]-Directed Dose Adjustment of Once Daily Intravenous Busulfan, Followed by Autologous Hematopoietic Stem Cell Transplant in
Overview
This is a study for the outcome and safety of individualized busulfan dosing with cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat Non-Hodgkin or Hodgkin's Lymphoma.
Basic Trial Information
| Phase | Type | Status | Age | Protocol ID(s) |
|---|---|---|---|---|
| II | Treatment | Active On-going | 18-80 | Otsuka OPDC 273-08-201 |
|
Cancer Types Lymphoma, Hodgkin, Adult Lymphoma, Non-Hodgkin, Adult |
||||
Medical Professionals
Evaluation of progression-free survival, transplant related mortality, overall survival, and overall response rate, in subjects with NHL and HL receiving an IV busulfan-based conditioning regimen with PK-guided IV busulfan dosing, followed by autologous HSCT as well as comparison to those receiving carmustine, etoposide, cytarabine, and melphalan (BEAM) conditioning regimen (and its variants) obtained from registry data in the Center for International Blood and Marrow Transplant Research (CIBMTR) Assessment of the safety profile of a BuCyE conditioning regimen with PK-directed dosing of IV busulfan will also be completed.
Primary Outcome Measures:
- Progression-free Survival
Secondary Outcome Measures:
- Overall Survival and Response Rate
Drug: IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen) Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant.
Explanation of Eligibility Criteria
Subjects with NHL to be included:
- Any subject with NHL that had relapsed or progressed following initial therapy with an anthracycline-based chemotherapy regimen and has achieved a subsequent partial remission (PR) or a complete remission (CR) following a salvage chemotherapy regimen.
- Any subject with NHL that was initially refractory to an anthracycline-based chemotherapy regimen but who has achieved a PR or CR following a salvage chemotherapy regimen.
- Any subject with an initial International Prognostic Index (IPI) score 4-5 who achieved a PR or any CR following an anthracycline-based chemotherapy regimen except subjects with Mantle cell, T cell and Natural Killer (NK) cell pathologies.
- Subjects with Mantle cell, T cell and NK cell lymphoma may be enrolled if they have PR or CR after initial therapy.
- Any subject that has relapsed or progressed following previous autologous HSCT.
Subjects with HL to be included:
- Any subject with HL that had relapsed or progressed following initial therapy with an multi-drug chemotherapy regimen and has achieved a subsequent PR or a CR following a salvage chemotherapy regimen.
- Any subject with HL that is initially refractory to a multi-drug chemotherapy regimen but who has achieved a PR or CR following a salvage chemotherapy regimen.
- Any subject that has relapsed or progressed following previous autologous HSCT.
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please call our Clinical Research Center at 407.303.2059 for additional information.
Our Web site gives a description of the clinical trials offered at the FHCI. Read over the information carefully and fully consider all of your options. Because trials can frequently change, call our Clinical Research Center at 407.303.2059 for the most up-to-date information. Please reference the protocol number (listed on the top of this page under Study Summary) when inquiring about a clinical trial.
