Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Hodgkins Lymphoma, Myelodysplastic Syndrome (MDS), Non-Hodgkins Lymphoma
Conditions
Keywords
Umbilical Cord Blood (UCB) Stem Cell Transplant, Hyperbaric oxygen, Leukemia, Lymphoma, MDS
Brief summary
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
Detailed description
Research has suggested that high levels of erythropoietin (EPO) decreases the ability of infused umbilical cord stem cells to home to the bone marrow. The investigators will investigate the use of hyperbaric oxygen (HBO) therapy to decrease the plasma concentrations of EPO prior to UBC transplant and evaluate the resulting impact on UBC homing.
Interventions
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
Sponsors
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation | Toxicity assessment with 24hrs of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Effects of HBO Therapy on Neutrophil Count Recovery. | Daily measurement of neutrophil counts up to 90 days post transplant. | Time in days until neutrophil count recovery is achieved; neutrophil count recovery is defined as three consecutive days of achieving a neutrophil level \>/= 500 u/L. |
| Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment. | 28 days | Complete engraftment is defined as as marrow reconstitution of greater than 90% of donor cells. Degree of engraftment will be determined through bone marrow chimerism assessment at either day 21 or day 28. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hyperbaric Oxygen Treatment Administration of hyperbaric oxygen the morning of UCB transplant.
Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Hyperbaric Oxygen Treatment |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 15 |
| serious Total, serious adverse events | 7 / 15 |
Outcome results
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.
Time frame: Toxicity assessment with 24hrs of treatment
Population: One patient treatment was shortened by approximately 10 minutes because of nausea attributed to concomitant medications.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hyperbaric Oxygen Treatment | Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation | grade IV leukopenia | 15 Participants |
| Hyperbaric Oxygen Treatment | Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation | grade III/IV neutropenia | 12 Participants |
| Hyperbaric Oxygen Treatment | Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation | grade III/IV anemia | 12 Participants |
| Hyperbaric Oxygen Treatment | Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation | grade III/IV thrombocytopenia | 13 Participants |
Secondary
Determine the Effects of HBO Therapy on Neutrophil Count Recovery.
Time in days until neutrophil count recovery is achieved; neutrophil count recovery is defined as three consecutive days of achieving a neutrophil level \>/= 500 u/L.
Time frame: Daily measurement of neutrophil counts up to 90 days post transplant.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperbaric Oxygen Treatment | Determine the Effects of HBO Therapy on Neutrophil Count Recovery. | 7 Days |
| Myeloablative Conditioning | Determine the Effects of HBO Therapy on Neutrophil Count Recovery. | 24.5 Days |
Secondary
Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.
Complete engraftment is defined as as marrow reconstitution of greater than 90% of donor cells. Degree of engraftment will be determined through bone marrow chimerism assessment at either day 21 or day 28.
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hyperbaric Oxygen Treatment | Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment. | 7 Participants |