Phase 2 Completed N=92 Treatment

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

Lymphoma · Multiple Myeloma · leukemia · Myelodysplastic Syndromes

Source: ClinicalTrials.gov NCT00809276 ↗

Enrolled (actual)

Serious AEs

43.5%

Results posted

Jan 2015

Primary outcomePrimary: 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 — 15 percentage of participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	15	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00809276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.