NCT00809276 · REGISTRY CONDITION SEARCH

Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2015-02-16

The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * 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 Exclusion Criteria: * 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
healthy Volunteers: false
maximum Age: 65 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

interventions

description
Busulfan once a day for 4 days Fludarabine once a day for 4 days Bone marrow transplant Cytoxan two doses
name
Busulfan, Fludarabine, Cytoxan
other Names
BMT
Cyclophosphamide
Allogeneic
Transplantation
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 92
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
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
time Frame
1 year

Full study description

brief Summary: The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.
detailed Description: A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT) However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT

Source references

references

citation
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
25267759
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice