Acute Myeloid Leukemia Clinical Trial
Official title:
A Pilot Study to Determine the Safety and Efficacy of Using Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
By doing this study, researchers hope to learn the following:
- If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC)
transplant will help to improve the homing process
- The safety of HBO administration in the setting of the UBC transplant
- The effects of HBO therapy on the engraftment process
Status | Active, not recruiting |
Enrollment | 15 |
Est. completion date | March 2016 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 17 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Voluntary written informed consent - Subjects must be >/= 17 yrs and </= 70 yrs for non-myeloablative transplant - Subjects must be >/= 17 yrs and </= 55 yrs for myeloablative transplant - Subjects with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS), Hodgkin's Lymphoma (HL) and Non-Hodgkin's Lymphoma (NHL) who are considered for UCB transplant - Use of approved form of contraception - Karnofsky performance status of >/= 70% - Adequate hepatic, renal, pulmonary and cardiac function. Criteria include: - ALT (alanine aminotransferase), AST (aspartate aminotransferase: < 4x IULN (institutional upper limit of normal) - Total bilirubin </= 2 mg/dL - Serum creatinine < 2.0 mg/dL - Left ventricular ejection fraction >/= 45% - FEV1 (forced expiratory volume), FVC (forced vital capacity) and DLCD (diffusing capacity of lung for carbon monoxide) >/= 50% of predicted value (corrected to serum hemoglobin) Exclusion Criteria: - Pregnancy or breast feeding - Severe chronic obstructive pulmonary disease requiring oxygen supplementation - History of spontaneous pneumothorax - History of seizures - Claustrophobia - Asthma - Uncontrolled viral or bacterial infection at the time of enrollment - Active or recent (prior 6 months) invasive fungal infection without interdisciplinary consult and approval |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To explore the effects of HBO therapy on inflammatory cytokines and EPO levels | Determine if inflammatory cytokine and EPO levels are dropping after the HBO treatment | Blood sample collection Pre-HBO (Day 0), 6hrs, 8hrs, 24hrs, 48hrs post HBO. | No |
Other | Determine the correlation between change in EPO levels and time to neutrophil recovery and engraftment. | Erythropoietin blood levels will be correlated to the daily neutrophil counts to assess any relationship between EPO levels and subsequent engraftment and neutrophil recovery. | EPO measurements: Pre-HBO (Day 0), 6hrs, 8hrs, 24hrs, 48hrs post HBO. | No |
Primary | Safety of HBO administration in the setting of UCB stem cell transplantation | Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be related to HBO therapy. | Toxicity assessment with 24hrs of treatment | Yes |
Secondary | Determine the effects of HBO therapy on neutrophil count recovery. | Subjects will be followed daily until neutrophil recovery, defined as three consecutive days of achieving a neutrophil level >/= 500 u/L. | Daily measurement of neutrophil counts up to 90 days post transplant. | No |
Secondary | Determine the effects of HBO therapy on engraftment | The degree of engraftment will be determined through bone marrow chimerism assessments at either 21 or 28 days. Partial engraftment is defined as marrow reconstitution of 10-90% or donor cells and complete engraftment is defined as greater that 90% of donor cells. | Bone marrow chimerism testing at Day 21 or Day 28 | No |
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