Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY
Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide
2 other identifiers
interventional
92
1 country
3
Brief Summary
The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 lymphoma
Started May 2009
Shorter than P25 for phase_1 lymphoma
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2008
CompletedFirst Posted
Study publicly available on registry
December 17, 2008
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
January 19, 2015
CompletedFebruary 16, 2015
January 1, 2015
2.6 years
December 16, 2008
December 19, 2014
January 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD
Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.
1 year
Interventions
Busulfan once a day for 4 days Fludarabine once a day for 4 days Bone marrow transplant Cytoxan two doses
Eligibility Criteria
You may qualify if:
- Patients ages between 0 to and 65 years of age.
- Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.
- Acute lymphocytic leukemia (ALL) in CR1 with high risk features
- Acute myeloid leukemia (AML) in CR1 with high risk features defined as:
- i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype \[\> 3 abnormalities\]
- Acute Leukemias in 2nd or greater remission
- Refractory or Relapsed AML
- AML transformed from MDS
- Myelodysplastic syndrome (MDS) beyond refractory anemia
- Chronic myeloid leukemia (CML)
- Chronic myelomonocytic leukemia
- Philadelphia-negative myeloproliferative disorder
- Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma
- Multiple Myeloma-Stage III
You may not qualify if:
- Prior autologous or allogeneic stem cell transplant.
- Performance status greater than 2
- Active infection.
- Inadequate cardiac function; arrythmias or symptomatic cardiac disease.
- Inadequate pulmonary function; FEV1, FVC, DLCO \<50% of predicted
- Inadequate Serum creatinine clearance \<60
- InadequatebHepatic function
- Positive serology for HIV-1, 2 or HTLV-1, 2.
- Pregnancy. Female patient must have negative pregnancy test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkinslead
- M.D. Anderson Cancer Centercollaborator
- Fred Hutchinson Cancer Centercollaborator
- Otsuka Pharmaceutical Co., Ltd.collaborator
Study Sites (3)
The Sydney Kimmel Comprehensive Cancer center
Baltimore, Maryland, 21231, United States
Marcos deLima, MD
Houston, Texas, 77030, United States
Paul V. O'Donnell, M.D., Ph.D.
Seattle, Washington, 98109, United States
Related Publications (1)
Kanakry CG, O'Donnell PV, Furlong T, de Lima MJ, Wei W, Medeot M, Mielcarek M, Champlin RE, Jones RJ, Thall PF, Andersson BS, Luznik L. Multi-institutional study of post-transplantation cyclophosphamide as single-agent graft-versus-host disease prophylaxis after allogeneic bone marrow transplantation using myeloablative busulfan and fludarabine conditioning. J Clin Oncol. 2014 Nov 1;32(31):3497-505. doi: 10.1200/JCO.2013.54.0625. Epub 2014 Sep 29.
PMID: 25267759DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Leo Luznik, MD
- Organization
- SKCCC
Study Officials
- STUDY CHAIR
Leo Luznik, MD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2008
First Posted
December 17, 2008
Study Start
May 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 16, 2015
Results First Posted
January 19, 2015
Record last verified: 2015-01