A Pilot Study to Determine the Safety and Efficacy of Incorporating Hyperbaric Oxygen Therapy Into RIC Fludarabine and Melphalan and Allogeneic Hematopoietic Stem/Progenitor Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 2
研究概览
简要总结
The purpose of this study is to determine if hyperbaric oxygen therapy is safe in the setting of stem cell transplantation. This study will also determine if hyperbaric oxygen therapy improves engraftment, graft versus host disease, neutrophil count, and incidence and severity of mucositis (inflammation of the mouth or gut) and infection. This study has two cohorts. The first cohort is subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS). The second cohort is subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), chronic monocytic leukemia, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic/myeloproliferative (MDS/MPN) overlap syndrome. The first cohort has completed the recruitment so only the second cohort will be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent
- •Men or women, age ≥ 18 years of age, with upper limit of 75 years old.
- •Subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS) for cohort
- •Subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), CML, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic/myeloproliferative (MDS/MPN) overlap syndrome for cohort
- •Karnofsky performance status (KPS) of ≥ 70%
- •Patients should have New York Heart Association (NYHA) Functional Classification, Class I (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain) or Class II (ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain).
- •Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include: Hepatic: ALT, AST < 4x IULN and serum total bilirubin ≤ 2.0 mg/dL; Renal: serum creatinine: ≤ 2.0 mg/dL; Left ventricular ejection fraction ≥ 45% measured by 2D-ECHO or MUGA scan; EKG with no clinically significant arrhythmia; FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin)
- •Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately.
- •A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- •Women of child-bearing potential should have a negative urine or serum pregnancy test within 4 weeks of starting preparative regimen
排除标准
- •Pregnant or breastfeeding
- •Severe chronic obstructive pulmonary disease requiring oxygen supplementation
- •History of spontaneous pneumothorax, prior chest surgery requiring thoracotomy or direct chest irradiation to the lungs
- •Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant.
- •Active malignancy excluding AML, MDS, CMML, aCML CML, CNL, MF and MDS/MPN overlap syndrome.
- •Active ear/sinus infection. Patients with chronic sinusitis or sinus headaches are excluded unless cleared by ear, nose, and throat specialist.
- •Recent sinus surgery (within the last 5 years).
- •Ear surgery excluding myringotomy or ear tubes
- •Subjects must agree to refrain from active tobacco or e-cigarette use 72 hours prior to transplant until complete transplant recovery. Nicotine replacement therapy is allowed.
- •Claustrophobia
- •History of recurrent seizures within 5 years of study enrollment.
- •Uncontrolled asthma
- •Uncontrolled viral or bacterial infection at the time of study enrollment
- •Active or recent (prior 6 months) invasive fungal infection without interdisciplinary (ID) consult and approval
- •Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen
研究组 & 干预措施
Cohort 1- AML or MDS
Patients with will receive HBO therapy one time on day 0 of the transplant. The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes (ATA) for a total of 90 minutes after compression to 2.5 atmosphere absolutes (ATA) in a monoplace hyperbaric chamber (Model 3200/3200R, Sechrist Industries, Inc., USA), breathing 100% oxygen. The subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes were spent during the compression and decompression phases and subjects had 10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment.
干预措施: Hyperbaric oxygen (Drug)
Cohort 2- CMML, aCML, CML, CNL, MDS/MPN
Patients with will receive HBO therapy one time on day 0 of the transplant. The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes (ATA) for a total of 90 minutes after compression to 2.5 atmosphere absolutes (ATA) in a monoplace hyperbaric chamber (Model 3200/3200R, Sechrist Industries, Inc., USA), breathing 100% oxygen. The subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes were spent during the compression and decompression phases and subjects had 10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment.
干预措施: Hyperbaric oxygen (Drug)
结局指标
主要结局
Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 2
时间窗: 100 days
Possible long-term effects of hyperbaric oxygen therapy treatment prior to allogeneic peripheral blood stem cell transplant will be assessed at day +100 post-transplant
Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 1
时间窗: 100 days
Possible long-term effects of hyperbaric oxygen therapy treatment prior to allogeneic peripheral blood stem cell transplant will be assessed at day +100 post-transplant
Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in Cohort 1
时间窗: 24 hours
Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.
Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in cohort 2
时间窗: 24 hours
Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.
次要结局
- Incidence of mucositis in Cohort 2(100 days)
- Time to complete donor chimerism in Cohort 1(100 days)
- Incidence of graft versus host disease in Cohort 1(100 days)
- Incidence of infection in Cohort 2(100 days)
- Incidence of infection in Cohort 1(100 days)
- Time to neutrophil recovery in Cohort 2(100 days)
- Time to complete donor chimerism in Cohort 2(100 days)
- Incidence of graft versus host disease in Cohort 2(100 days)
- Time to neutrophil recovery in Cohort 1(100 days)
- Incidence of mucositis in Cohort 1(100 days)
研究者
Omar Aljitawi
Associate Professor of Hematology/Oncology
University of Rochester