Evaluation of Plasmatic Levels of Busulfan in Patients Undergoing Hematopoietic Stem Cell Transplantation

NCT01800643 | Unknown Phase 2 DMC

• 1 other identifier: Busulfan-2013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective study is evaluate the best dose of busulfan for each patient undergoing Haematopoietic Stem Cell Transplantation

Conditions

Acute Leukemia; Chronic Leukemia; Lymphoproliferative Disease; Myeloproliferative Disease; Immunodeficiency

Keywords

Busulfan; plasmatic dosage; Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Dosing of plasmatic levels of busulfan

  To study the effectiveness dosing of busulfan plasma levels during the administration of orally busulfan or intravenous prior to HSCT (test dose) and correlate with the respective plasma measurements in the first days of conditioning

  2 years

Secondary Outcomes (4)

• Overall Survival

  5 years

• Cumulative incidence of relapse and non relapse mortality

  5 years

• Disease Free Survival

  1 year

• Toxicity

  1 year

Study Arms (2)

Orally Busulfan PK

OTHER

Evaluate the Pharmacokinetics of orally busulfan

Other: Analyze the pharmacokinetics of busulfan for transplantation

Intravenously Busulfan PK

OTHER

Evaluate the Pharmacokinetics of intravenously busulfan

Other: Analyze the pharmacokinetics of busulfan for transplantation

Interventions

Analyze the pharmacokinetics of busulfan for transplantation OTHER

Evaluate the Bu pharmacokinetics (PK) when the drug will be received by P.O or I.V and we will establish the target "Area Under Curve- AUC" based on a single daily dose (test dose) before HSCT. The test dose of orally Bu is 1 mg/Kg and the blood samples are collected and processed in time: 0h, 30 min, 1h, 1,5h, 2h, 3h, 4h, 5h and 6h after drug intake. After extraction of the plasma samples busulfan, quantitative analyzes of busulfan on human plasma will be performed by the liquid chromatograph. For the patients that will receive intravenously busulfan, the test dose is 32 mg/m2 and blood samples are collected in time: 0h, 30', 45', 1h, 2h, 3h, 4h, 5h, 6h and 8h after drug intake. The dose during the conditioning will depend on the test dose and the AUC target.

Also known as: Busulfan dosing, Busulfan Pharmacokinetics, Busilvex, Myleran

Intravenously Busulfan PK; Orally Busulfan PK

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of hematologic or non-hematologic pathology using as part of the conditioning regimen busulfan;
• Men, women and children regardless of age;
• Performance Status\> 80 or ECOG \<2;
• Total bilirubin \<2 mg / dl and transaminases \<3 times the upper limit of normal;
• Creatinine \<1.5 mg / dl;
• LVEF\> 50% by echocardiogram or MUGA at rest;
• Pulmonary function test with FEV1\> 70%;
• Consent form signed before the start of any specific procedure.

You may not qualify if:

• Presence of infectious process in uncontrolled activity;
• Presence of psychiatric disorder;
• Pregnancy;

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05651901, Brazil

RECRUITING

Related Publications (1)

• Esteves I, Santos FPS, Fernandes JF, Seber A, Oliveira JSR, Hamerschlak N, Kerbauy FR, S Andersson B, de Lima M. Pharmacokinetics analysis results are similar for oral compared to intravenous busulfan in patients undergoing hematopoietic stem cell transplantation, except for the earlier onset of mucositis. A controlled clinical study. Bone Marrow Transplant. 2019 Nov;54(11):1799-1804. doi: 10.1038/s41409-019-0521-5. Epub 2019 May 14.

  PMID: 31089278 DERIVED

MeSH Terms

Conditions

Lymphoproliferative Disorders; Myeloproliferative Disorders; Immunologic Deficiency Syndromes

Interventions

Transplantation; Busulfan

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Nelson Hamerschlak, Doctor

  Hospital Israelita Albert Einstein

  STUDY CHAIR

Central Study Contacts

Iracema Esteves, investigator

CONTACT

(5511)963010921; iestevesmed@yahoo.com.br

Sandra Nakashima, nurse

CONTACT

(5511)21511128; sandra.nakashima@einstein.br

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: MD

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: February 28, 2013
• Study Start: March 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

BR (1)