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A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant (HBO-UBC)

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ClinicalTrials.gov Identifier: NCT03739502
Recruitment Status : Not yet recruiting
First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Omar Aljitawi, University of Rochester

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).

Condition or disease Intervention/treatment Phase
AML NHL Hodgkin Disease All Drug: Hyperbaric oxygen Phase 2

Detailed Description:

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.

This research study is aimed at investigating the use of hyperbaric oxygen (HBO) therapy prior to the UCB transplant to find out if it will improve the stem cell homing, and subsequently, the engraftment. HBO therapy involves breathing 100% pure oxygen while in a sealed chamber that has been pressurized at 2 ½ times the normal atmospheric pressure.

There is a specific hormone which tells stem cells in the bone marrow to make more red blood cells. This hormone (called EPO) is increased when blood oxygen levels are low. When the EPO is increased, it might impair the bone marrow homing process of your transplant. Therefore, the researchers conducting this study hope to determine if providing 100% pure oxygen to you prior to your UCB transplant will decrease this hormone, and in turn, improve the homing process after your transplant.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Randomized Phase II Study Evaluating the Efficacy of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplantation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study Evaluating the Efficacy of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplantation
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: HBO arm Drug: Hyperbaric oxygen

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.


No Intervention: non-HBO arm



Primary Outcome Measures :
  1. Time to neutrophil recovery [ Time Frame: 100 days ]

Secondary Outcome Measures :
  1. Time to platelet count recovery. [ Time Frame: 100 days ]
  2. Time to transfusion independency for red blood cells. [ Time Frame: 100 days ]
  3. Time to transfusion independency for platelets. [ Time Frame: 100 days ]
  4. Time to full donor chimerism. [ Time Frame: 100 days ]

Other Outcome Measures:
  1. Serum EPO blood levels. [ Time Frame: 100 days ]
  2. Percentage of CD34+EPOR+ cells in infused UCB units. [ Time Frame: 100 days ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 define 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 CEBPA56,57), 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 population58or undifferentiated leukemia in ≥CR1. Chemotherapy sensitive (achievement of at least a partial response according to Lugano classification59) 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 criteria60, these criteria are:

  1. High white blood cell count at diagnosis (ie, >30,000/microL in B-ALL or >100,000/microL in T-ALL).
  2. Clonal cytogenetic abnormalities - t(4;11), t(1;19), t(9;22), or BCR-ABL gene positivity.
  3. Progenitor-B cell immunophenotype (eg, blasts expressing membrane CD19, CD79a, and cytoplasmic CD22).
  4. Length of time from start of induction therapy to attainment of CR greater than four weeks.
  5. Older age - >60 years old is high risk, 30 to 59 years old is intermediate risk.
  6. 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
      • Creatinine: ≤ 1.5 x ULN
      • EF measured by 2D-ECHO or MUGA scan of ≥ 45%
      • FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin).
      • EKG with no clinically significant arrhythmia.
    • Patients should have New York Heart Association (NYHA) Functional Classification, class -1 or II (No or mild limitation during ordinary activity).
    • Patients should be evaluated for fitness for HBO by a hyperbaric oxygen trained medical professional who is not part of the study team prior to starting preparative regimen.
    • Women of child-bearing potential should have a negative urine pregnancy test within 4 weeks of starting preparative regimen.
    • 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)

Exclusion Criteria:

  • Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.

    • Pregnant or breastfeeding
    • Severe chronic obstructive pulmonary disease requiring oxygen supplementation
    • History of spontaneous pneumothorax
    • Active ear/sinus infection
    • Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging.
    • Prior chest surgery requiring thoracotomy or direct chest irradiation.
    • History of sinus or ear surgery, excluding myringotomy or ear tubes.
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739502


Contacts
Contact: Kaitlyn Burrows (585) 275-5150 Kaitlyn_Burrows@URMC.Rochester.edu

Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Omar Aljitawi University of Rochester

Responsible Party: Omar Aljitawi, Associate Professor of Hematology/Oncology, University of Rochester
ClinicalTrials.gov Identifier: NCT03739502     History of Changes
Other Study ID Numbers: 67536
UBMT17044 ( Other Identifier: Wilmot Cancer Institute )
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases