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Hyperbaric Oxygen Therapy for Hematopoietic Progenitor Cell Collection in Poor Mobilizers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682953
Recruitment Status : Withdrawn (subject recruitment not feasible due to standard care changes)
First Posted : February 17, 2016
Last Update Posted : December 11, 2019
Sponsor:
Collaborator:
Healogics
Information provided by (Responsible Party):
Stephen Thom, University of Maryland, Baltimore

Brief Summary:
This is a pilot study to evaluate the efficacy of hyperbaric oxygen therapy (HBO2) for mobilizing hematopoietic progenitor cells from bone marrow to blood. These cells are needed for patients to undergo bone marrow transplantation and some patients fail to respond to current best chemotherapy. HBO2 has been shown to trigger stem cell mobilization in other patient populations and we plan to investigate whether this intervention can act in concert with chemotherapeutic agents to allow poor mobilizer patients to achieve successful bone marrow transplantation. Twenty patients will be identified by participating hematologists who have failed to respond adequately to chemotherapy. When it is deemed appropriate to attempt an additional stem cell mobilization protocol, these patients will be administered chemotherapy as determined by their primary treating hematologist and additionally receive daily HBO2 (2.5 atmospheres absolute [ATA] for 90 minutes) for 3-8 days. At intervals, blood samples will be obtained as is the normal transplantation protocol practice to assess whether adequate stem cells are present in blood for the patient to proceed with transplantation. The project is anticipated to take one year to complete.

Condition or disease Intervention/treatment Phase
Bone Marrow Transplantation Hematopoietic Stem Cells Multiple Myeloma Lymphoma Drug: Neupogen Procedure: Hyperbaric oxygen therapy Drug: Plerixafor Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy for Hematopoietic Progenitor Cell Collection in Poor Mobilizers
Study Start Date : October 2015
Estimated Primary Completion Date : February 2017
Actual Study Completion Date : August 2017


Arm Intervention/treatment
Experimental: Hyperbaric oxygen therapy
Exposure to oxygen at 2.4 atmospheres absolute for 90 minutes/day for 3 to 5 days
Drug: Neupogen
Pharmacological agents often used for stem cell mobilization will be utilized in this study.
Other Name: Plerixafor

Procedure: Hyperbaric oxygen therapy
Exposure to oxygen at 2.4 atmospheres absolute for 90 minutes/day for 3 to 5 days

Drug: Plerixafor
Pharmacological agents often used for stem cell mobilization will be utilized in this study.




Primary Outcome Measures :
  1. Number of patients who adequately mobilize stem cells to undergo bone marrow transplantation. [ Time Frame: 1-2 years ]
    Among entered patients, the number who adequately mobilization of stem cells to proceed with bone marrow transplantation



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical indication for hematopoietic stem cell transplantation.
  2. Those failing to achieve an adequate collection of progenitor cells with standard chemotherapy treatment to safely perform hematopoietic stem cell transplantation.

Exclusion Criteria:

  1. Diabetes mellitus
  2. Renal or other organ transplantation and on immunosuppressive agents
  3. NYHA Class III or IV heart failure
  4. Liver cirrhosis
  5. HIV infection and/or AIDS
  6. Seizure disorder and not taking anti-seizure medications
  7. Asthma/bronchospasm not resolvable with inhaled bronchodilators
  8. Eustachian tube dysfunction and inability to equalization of pressure across the middle ears
  9. Confinement anxiety not controlled with oral benzodiazepine therapy.

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): NCT02682953


Locations
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United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Healogics
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Responsible Party: Stephen Thom, Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT02682953    
Other Study ID Numbers: HP-00064099
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data on stem cell changes with treatment
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Plerixafor octahydrochloride
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents