Fludarabine Phosphate, Clofarabine, and Busulfan With Vorinostat in Treating Patients With Acute Leukemia in Remission or Relapse Undergoing Donor Stem Cell Transplant
NCT ID: NCT02083250
Last Updated: 2022-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
70 participants
INTERVENTIONAL
2014-03-06
2021-11-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia
NCT00469014
Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia
NCT00860574
Busulfan and Fludarabine Before Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
NCT00301912
Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer
NCT00053196
Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant
NCT02861417
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To determine the maximum tolerated dose (MTD) of SAHA (vorinostat) in combination with the preparative regimen fludarabine (fludarabine phosphate), clofarabine, and busulfan followed by allogeneic hematopoietic stem cell transplantation (SCT) for patients with advanced acute leukemia.
SECONDARY OBJECTIVES:
I. To determine the rate of graft versus host disease (GVHD), engraftment, progression-free survival (PFS) and overall survival (OS) for this treatment regimen.
OUTLINE: This is a dose-escalation study of vorinostat.
CONDITIONING REGIMEN: Patients receive vorinostat orally (PO) once daily (QD), fludarabine phosphate intravenously (IV) over 1 hour, clofarabine IV over 1 hour, and busulfan IV over 3 hours on days -6 to -3. Patients receiving a transplant from a human leukocyte antigen (HLA)-matched unrelated donor, receive anti-thymocyte globulin IV over 4 hours on days -3 to -1.
TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell or bone marrow transplant on day 0.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment (vorinostat, chemotherapy, SCT)
CONDITIONING REGIMEN: Patients receive vorinostat PO QD, fludarabine phosphate IV over 1 hour, clofarabine IV over 1 hour, and busulfan IV over 3 hours on days -6 to -3. Patients receiving a transplant from a HLA-matched unrelated donor, receive anti-thymocyte globulin IV over 4 hours on days -3 to -1.
TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell or bone marrow transplant on day 0.
Allogeneic Bone Marrow Transplantation
Undergo allogeneic peripheral blood stem cell or bone marrow transplant
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic peripheral blood stem cell or bone marrow transplant
Anti-Thymocyte Globulin
Given IV
Busulfan
Given IV
Clofarabine
Given IV
Fludarabine Phosphate
Given IV
Peripheral Blood Stem Cell Transplantation
Undergo allogeneic peripheral blood stem cell or bone marrow transplant
Pharmacological Study
Correlative studies
Vorinostat
Given PO
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Allogeneic Bone Marrow Transplantation
Undergo allogeneic peripheral blood stem cell or bone marrow transplant
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic peripheral blood stem cell or bone marrow transplant
Anti-Thymocyte Globulin
Given IV
Busulfan
Given IV
Clofarabine
Given IV
Fludarabine Phosphate
Given IV
Peripheral Blood Stem Cell Transplantation
Undergo allogeneic peripheral blood stem cell or bone marrow transplant
Pharmacological Study
Correlative studies
Vorinostat
Given PO
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Estimated creatinine clearance at least 50 ml/min
* Bilirubin equal or less than 1.5 (unless Gilbert's syndrome)
* Serum glutamate pyruvate transaminase (SGPT) \< 3 x upper limit of normal
* Alkaline phosphatase \< 2 x upper limit of normal
* Pulmonary function with forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO) at least 45% of expected corrected for hemoglobin; children unable to perform pulmonary functions must have an oxygen saturation greater than 92% at room air
* Left ventricular ejection fraction at least 45% on appropriate medical therapy; no uncontrolled arrhythmias or symptomatic cardiac disease
* Zubrod performance status 0-1 or Lansky/Karnofsky performance status (PS) equal or greater to 80%
* Patients must have a related, genotypically HLA identical donor, or they must have an unrelated donor who is 8/8 HLA match by high resolution typing
* Patient or patient's legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant's age is at least seven and less than eighteen years
* Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months and no previous surgical sterilization
Exclusion Criteria
* Evidence of acute or chronic active hepatitis or cirrhosis
* Uncontrolled infection, including human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV)-1, hepatitis B or hepatitis C viremia
* Prior allogeneic SCT
* Prior autologous SCT in last 12 months
* Patients with acute myeloid leukemia (AML) in first remission after one course of induction and with favorable cytogenetics (t\[8;21\], inv 16, or t\[15;17\]) and/or molecular profile (nucleophosmin \[NPM\]1)
* Prior radiation to liver in form of total body or involved field
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Partow Kebriaei
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
M D Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
MD Anderson Cancer Center Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2014-01982
Identifier Type: REGISTRY
Identifier Source: secondary_id
2012-0999
Identifier Type: OTHER
Identifier Source: secondary_id
2012-0999
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.