Phase 2 Completed N=56 Treatment

Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide

Hematologic Diseases · leukemia · Lymphoma · Multiple Myeloma

Source: ClinicalTrials.gov NCT00800839 ↗

Enrolled (actual)

Serious AEs

69.6%

Results posted

Sep 2016

Primary outcomePrimary: Cumulative Incidence of Grade II to IV Acute GVHD — 53 percentage of incidence

Summary

The goal of this clinical research study is to learn if cyclophosphamide given after busulfan and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which transplanted tissue attacks the body into which it is transplanted) in patients receiving a stem cell transplant. The safety of this drug combination will also be studied.

Outcome Measures

Outcome	Result	p-value
PRIMARY Cumulative Incidence of Grade II to IV Acute GVHD	53	—
PRIMARY Cumulative Incidence of Grade III to IV Acute GVHD	22	—
PRIMARY Day-100 Treatment-Related Mortality	14	—
SECONDARY Rate of Engraftment	18	—
SECONDARY 2-year Progression-Free Survival	26	—
SECONDARY 2-year Overall Survival	33	—

Eligibility Criteria

Inclusion Criteria

Patients with high risk hematological malignancies, including those with induction failure and after treated or untreated relapse.
HLA-identical sibling or matched unrelated donor transplants not eligible for protocols of higher priority.
Age 6 months to 75 years.
Bilirubin 50mL/min using the Cockcroft-Gault equation for adult patients 18 to 70 years old, and the Schwartz equation for pediatric patients 6 months to 17 years old.
Diffusing capacity for carbon monoxide (DLCO) >45% predicted corrected for hemoglobin (as reported by the Pulmonary Function Laboratory at MDACC). For most children /= 92% on room air.
left ventricular ejection fraction (LVEF) >/= 35%.

Exclusion Criteria

HIV seropositivity
Uncontrolled infections.
Positive Beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Inability to sign consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00800839). 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.