A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant

NCT03739502 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 67536UBMT17044
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs).

Conditions

AML; NHL; Hodgkin Disease; All; Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• Time to neutrophil recovery

  100 days

Secondary Outcomes (4)

• Time to platelet count recovery.

  100 days

• Time to transfusion independency for red blood cells.

  100 days

• Time to transfusion independency for platelets.

  100 days

• Time to full donor chimerism.

  100 days

Other Outcomes (2)

• Serum EPO blood levels.

  100 days

• Percentage of CD34+EPOR+ cells in infused UCB units.

  100 days

Study Arms (2)

HBO arm

EXPERIMENTAL

Drug: Hyperbaric oxygen

non-HBO arm

NO INTERVENTION

Interventions

Hyperbaric oxygen DRUG

The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs). However, UCB as a graft source for a bone marrow transplant has drawbacks related to the limited cell dose available for transplant and defects in homing. Homing is the process of UCB stem cell lodging in the bone marrow. If the homing is not efficient it could delay the re-population of the stem cells (or engraftment), possibly lead to engraftment failure, and delay the rebuilding of the immune system after transplant. This could, in turn, provide a higher risk to infection after the UCB transplant.

HBO arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent
• Patients who are considered for allogeneic transplantation based on their disease risk (see below) but lack matched sibling or unrelated donors or who are unable to proceed to allogeneic transplant within 8 weeks, will be considered for UCB transplantation on this study. Only patients for whom RIC will be considered are eligible. RIC is considered in those older than 45 or younger than 45 with Hematopoietic Cell Transplant (HCT) Comorbidity Index of 3 or higher (HCT) Comorbidity Index can be calculated using the following link: http://www.hctci.org/Home/Calculator
• Patients with acute myeloid leukemia (AML) in CR1 that is not considered favorable-risk (favorable risk is defined as patients with t(15;17)(q22;q21), t(8;21)(q22;q22), inv(16)(p13q22)/t(16;16)(p13;q22), NPM1 mutation without FLT3-ITD, and double-mutated CEBPA58,59), AML in CR2 or subsequent CR, high-risk acute lymphoblastic leukemia (ALL) in CR1, or ALL in CR2 or higher, biphenotypic leukemia defined as coexpression of B-lymphoid and myeloid markers or T-lymphoid and myeloid markers in the blast population60or undifferentiated leukemia in ≥CR1. Myelodysplatic syndrome (MDS)/myeloproliferative neoplasm (MPN) patients with less than 10% bone marrow blasts and no peripheral blood blasts on pre-transplant bone marrow aspirate/biopsy are considered for FluCyTTBI regimen. Chemotherapy sensitive (achievement of at least a partial response according to Lugano classification61) Hodgkin's disease (HD) that relapsed following high-dose therapy. Chemotherapy sensitive (achievement of at least a partial response according to Lugano classification) non-Hodgkin's lymphoma (NHL) patients who relapsed post-high-dose therapy and autologous transplantation. Subjects should be enrolled within 30 days of transplant.
• For ALL, high-risk features are defined using modified Hoelzer risk criteria62, these criteria are:
• High white blood cell count at diagnosis (ie, \>30,000/microL in B-ALL or \>100,000/microL in T-ALL).
• Clonal cytogenetic abnormalities - t(4;11), t(1;19), t(9;22), or BCR-ABL gene positivity.
• Progenitor-B cell immunophenotype (eg, blasts expressing membrane CD19, CD79a, and cytoplasmic CD22).
• Length of time from start of induction therapy to attainment of CR greater than four weeks.
• Older age - \>60 years old is high risk, 30 to 59 years old is intermediate risk.
• MRD - a post-remission bone marrow MRD level ≥10-3 by molecular tests.
• Subjects must be ≥ 18 years old and ≤ 70 years old
• Karnofsky performance status (KPS) of ≥ 70% (Appendix A).
• Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include:
• ALT, AST: \< 4x IULN
• Total bilirubin: ≤ 2.0 mg/dL

You may not qualify if:

• Pregnant or breastfeeding
• Severe chronic obstructive pulmonary disease requiring oxygen supplementation
• History of spontaneous pneumothorax
• Active ear/sinus infection. Patients with chronic sinusitis or sinus headaches are excluded unless cleared by ear, nose, throat provider.
• Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant.
• Prior chest surgery requiring thoracotomy or direct chest irradiation.
• Recent of sinus or ear surgery, excluding myringotomy or ear tubes (within the last 5 years).
• Claustrophobia
• Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen.
• History of seizures
• No active tobacco use 72 hours prior to transplant until complete transplant recovery.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Omar Aljitawi

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlyn Burrows

CONTACT

(585) 275-5150; Kaitlyn_Burrows@URMC.Rochester.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Hematology/Oncology

Model Details: A Randomized Phase II Study Evaluating the Efficacy of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplantation

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: February 28, 2019
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

US (1)