Busulfan Pharmacokinetic Analysis and GST Polymorphism in Adults Undergoing Hematological Stem Cell Transplantation
This study is enrolling participants by invitation only.
Sponsor:
Rambam Health Care Campus
Collaborator:
Israel Cancer Association
Information provided by (Responsible Party):
N_Krivoy, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01071486
First received: February 18, 2010
Last updated: May 25, 2012
Last verified: May 2012
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Purpose
Between 100 up to 200 adults undergoing HSCT for their primary disease will be included in this pharmacokinetic/pharmacogenetic study. In the preparative protocol Busulfan (BU)will be included as indicated in a known protocol. The GST polymorphism (A1,M1,T1 and P1) will be investigated using real time PCR. A correlation between pharmacokinetic parameters and patients polymorphism will be performed using known statistical technics for comparison. The aims of this study are, to correlate the demographic data, clinical presentation, clinical outcomes of the included individuals, the BU kinetics and the GST polymorphism and to establish an outcome "map" for those who receive HSCT for their primary disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Busulfan Pharmacokinetic Analysis GST Genetic Polymorphism |
Drug: Hematological Stem Cell Transplantation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Busulfan Pharmacokinetic Analysis and Glutathione S-transferase (GST)Genetic Polymorphism (A1,T1,M1,P1)in Adults Undergoing Hematological Bone Marrow Transplantation (HSCT). |
Resource links provided by NLM:
Further study details as provided by Rambam Health Care Campus:
Primary Outcome Measures:
- Hepatic Veno-Occlusive Disease, Graft versus host disease [ Time Frame: every week after HSCT up to 6 month ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Hematological Stem Cell Transplantation
Oral or Intravenous Busulfan as part of the preparative protocol for transplantation
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Malignant or Benign Diseases who need hematological stem cell transplantation as part of their treatment
- Busulfan should be part of the preparative protocol
Exclusion Criteria:
- Known sensitivity or allergy to Busulfan
Contacts and Locations More Information
No publications provided
| Responsible Party: | N_Krivoy, Clinical Pharmacology Unit, Rambam Health Care Campus |
| ClinicalTrials.gov Identifier: | NCT01071486 History of Changes |
| Other Study ID Numbers: | BU-AdultPK/PGx1 |
| Study First Received: | February 18, 2010 |
| Last Updated: | May 25, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Rambam Health Care Campus:
|
Busulfan Glutathione S-transferase Genetic polymorphism HVOD GVHD |
Additional relevant MeSH terms:
|
Busulfan 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 |
ClinicalTrials.gov processed this record on May 19, 2013