PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborator:
Center for International Blood and Marrow Transplant Research
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00948090
First received: July 28, 2009
Last updated: April 4, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 Subjects With Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma |
Resource links provided by NLM:
Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Primary Outcome Measures:
- Progression-free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Survival and Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 210 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion 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.
Exclusion Criteria:
- Any subject with chemoresistant disease by demonstration of less than PR to most recent chemotherapy, and any subject with prior treatment history of autologous HSCT or high-dose chemotherapy with stem cell rescue for any medical reason will be excluded.
Excluded will also be subjects with existing or active central nervous system lymphoma or human immunodeficiency virus related lymphoma, unacceptable organ function, or uncontrolled infections.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948090
Show 42 Study Locations
Show 42 Study LocationsSponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Center for International Blood and Marrow Transplant Research
Investigators
| Study Director: | Agnes Elekes, MD | Otsuka Pharmaceutical Development and commercialization |
More Information
No publications provided
| Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| ClinicalTrials.gov Identifier: | NCT00948090 History of Changes |
| Other Study ID Numbers: | 273-08-201 |
| Study First Received: | July 28, 2009 |
| Last Updated: | April 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
|
Hodgkin Lymphoma Non-Hodgkin's Lymphoma Bone marrow transplant stem cell transplant |
busulfan cyclophosphamide etoposide |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Busulfan Cyclophosphamide Etoposide phosphate Etoposide |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antirheumatic Agents Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 18, 2013