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Trial record 30 of 1808 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

Bone Marrow Transplantation Using CD34-Selected Stem Cells From Related or Unrelated Donors in Treating Participants With Cancer or Other Disorders

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ClinicalTrials.gov Identifier: NCT03626285
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eneida Nemecek, OHSU Knight Cancer Institute

Brief Summary:
This expanded access protocol studies bone marrow transplantation using CD34-selected stem cells from related or unrelated donors in treating participants with cancer or other disorders. Stem cells collected from the donor will be processed using a new device called CliniMACS CD34 Reagent System which marks the blood cells collected from the donor with a special protein called "antibody" that tags only the donor stem cells, sorting out other cells of the blood and immune system. This is done to remove, at least partially, some of the T cells. T cells are the cells in the blood that work as scavengers of the immune system deciding what belongs and what does not. These cells can sometimes cause rejection of the donor graft or a condition called graft-versus host disease (GVHD), where the donor cells can attack the body of the recipient. A bone marrow transplantation using CD34-selected stem cells may reduce the risk of these unwanted side effects of transplant as much as possible.

Condition or disease Intervention/treatment Phase
Benign Neoplasm Bone Marrow Transplantation Recipient Hematopoietic Cell Transplantation Recipient Malignant Neoplasm Procedure: Bone Marrow Transplantation Device: CliniMACS CD34 Reagent System Procedure: Peripheral Blood Stem Cell Transplantation Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To provide a source of CD34-selected stem cells for patients with malignant and nonmalignant disorders undergoing bone marrow transplantation from haploidentical (human leukocyte antigen [HLA]-mismatched) related donors or HLA-compatible unrelated donors

SECONDARY OBJECTIVES:

I. Monitoring the safety of the CD34-selected stem cells for the recipient, as measured by adverse events related to stem cell infusion, incidence of engraftment of neutrophils and platelets, incidence of acute and chronic GVHD, and one year overall survival, disease-free survival, and primary disease recurrence.

OUTLINE:

Donor stem cells undergo CD34 selection ex vivo using the CliniMACS CD34 Reagent System using standard operating procedures (SOPs) from the manufacturer. Recipients undergo standard of care preparative regimen, bone marrow transplantation with CD34-selected peripheral blood stem cells via infusion over 1 to 2 hours on day 0, and then receive standard of care GVHD prophylaxis.

After completion of study treatment, recipients are followed up at least once weekly while inpatient until transplant day 100, every 1-3 months for the first year and yearly thereafter.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Institutional Protocol of Bone Marrow Transplantation Using CD34-Selected Peripheral Blood Stem Cells From Related Haploidentical or Unrelated Donors for Treatment of Malignant and Nonmalignant Disorders
Actual Study Start Date : August 6, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (BMT with CD34 peripheral blood stem cells)
Donor stem cells undergo CD34 selection ex vivo using the CliniMACS CD34 Reagent System using SOPs from the manufacturer. Recipients undergo standard of care preparative regimen, bone marrow transplantation with CD34-selected peripheral blood stem cells via infusion over 1 to 2 hours on day 0, and then receive standard of care GVHD prophylaxis.
Procedure: Bone Marrow Transplantation
Undergo BMT
Other Names:
  • BMT
  • Bone Marrow Grafting
  • Bone marrow transplant
  • Marrow Transplantation

Device: CliniMACS CD34 Reagent System
CD34 selection ex vivo

Procedure: Peripheral Blood Stem Cell Transplantation
Receive CD34-selected peripheral blood stem cells from related or unrelated donors
Other Names:
  • PBPC transplantation
  • PBSCT
  • Peripheral Blood Progenitor Cell Transplantation
  • Peripheral Stem Cell Support
  • Peripheral Stem Cell Transplant
  • Peripheral Stem Cell Transplantation




Primary Outcome Measures :
  1. Recipient demographics (age, gender, ethnicity) [ Time Frame: Up to 3 years ]
    All endpoints will be descriptive only. No formal comparisons or statistical analysis other than descriptive statistics. Categorical variables (adverse events) will be described as proportions.

  2. Donor demographics (age, gender, degree of human leukocyte antigen [HLA]-mismatch with recipient) [ Time Frame: Up to 3 years ]
    All endpoints will be descriptive only. No formal comparisons or statistical analysis other than descriptive statistics. Categorical variables (adverse events) will be described as proportions.


Secondary Outcome Measures :
  1. Graft characteristics (total cell dose, number of leukocytes, number of CD34 positive cells pre and post-processing, number of CD3 positive [T-cells] pre and post processing, % viability) [ Time Frame: Up to 3 years ]
    All endpoints will be descriptive only. No formal comparisons or statistical analysis other than descriptive statistics. Categorical variables (adverse events) will be described as proportions. Numerical variables (graft composition characteristics) will be described using median and range.

  2. Incidence of adverse events during stem cell infusion [ Time Frame: Over 1-2 hours during infusion on day 0 ]
    All endpoints will be descriptive only. No formal comparisons or statistical analysis other than descriptive statistics. Categorical variables (adverse events) will be described as proportions.

  3. Incidence of engraftment of neutrophils [ Time Frame: 2 days post-transplant ]
    Neutrophil engraftment will be measured as achievement of absolute neutrophil count of 500/mm^3 for two consecutive days after transplantation. All endpoints will be descriptive only. No formal comparisons or statistical analysis other than descriptive statistics. Categorical variables (incidence of engraftment) will be described as proportions.

  4. Incidence of engraftment of platelets [ Time Frame: 7 days post-transplant ]
    Platelet engraftment will be measured as achievement of platelet count of 20,000/mm^3 in the absence of platelet transfusions for at least 7 consecutive days. All endpoints will be descriptive only. No formal comparisons or statistical analysis other than descriptive statistics. Categorical variables (incidence of engraftment) will be described as proportions.

  5. Incidence of acute and chronic Graft Versus Host Disease (GVHD) [ Time Frame: Up to 3 years ]
    This is defined and graded by standard classification systems. All endpoints will be descriptive only. No formal comparisons or statistical analysis other than descriptive statistics. Numerical variables (graft composition characteristics) will be described using median and range. Time dependent variables (GVHD) will be described using cumulative incidence and Kaplan-Meier methods.

  6. Survival status [ Time Frame: Up to 3 years ]
    All endpoints will be descriptive only. No formal comparisons or statistical analysis other than descriptive statistics. Time dependent variables (survival) will be described using cumulative incidence and Kaplan-Meier methods.

  7. Primary disease status [ Time Frame: Up to 3 years ]
    For malignant disorders this will be recorded as presence or absence of relapse. For nonmalignant disorders this will be recorded as absence of active disease. All endpoints will be descriptive only. No formal comparisons or statistical analysis other than descriptive statistics. Time dependent variables (survival, relapse and GVHD) will be described using cumulative incidence and Kaplan-Meier methods.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with malignant or nonmalignant diseases that can benefit from alternative stem cell transplantation according to institutional standard practice guidelines
  • Patients lacking a healthy human leukocyte antigen (HLA)-identical related donor and having one of the following alternative donor sources:

    • HLA-haploidentical related (HLA antigen genotypic match >= 4/8 and <= 7/8) or
    • Unrelated donor that is HLA matched at >= 7/8 HLA antigen loci
  • The selected donor must also be:

    • Able to receive granulocyte colony-stimulating factor (G-CSF, filgrastim) and undergo apheresis either through placement of peripheral or temporary central venous catheter, based on institutional guidelines for peripheral blood stem cell collection
    • Meet all institutional standard criteria for clearance for peripheral stem cell collection
  • Recipients must meet institutional treatment standards based on pre-transplant evaluations including:

    • Adequate major organ functions
    • Free of major systemic infections
    • Not pregnant, if female of childbearing age (post-pubertal)
  • Recipient (if >= 18 years) or their parent/legal guardian (if < 18 years) must be able to sign the informed consent form for the treatment plan; assent will be obtained from recipients 7-17 years of age, in accordance to our institutional guidelines

Exclusion Criteria:

  • Patients not meeting clearance criteria for bone marrow transplantation (BMT) based on standard institutional guidelines
  • Presence of anti-HLA antibodies against donor antigens in a recipient or anti-HLA antibodies against recipient antigens in a donor
  • Known allergy to murine (mouse) protein or iron-dextran

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): NCT03626285


Contacts
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Contact: Eneida Nemecek, MD 503-494-0829 nemeceke@ohsu.edu

Locations
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United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Eneida R. Nemecek    503-494-0829    nemeceke@ohsu.edu   
Principal Investigator: Eneida R. Nemecek         
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Eneida Nemecek, MD OHSU Knight Cancer Institute

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Responsible Party: Eneida Nemecek, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT03626285     History of Changes
Other Study ID Numbers: IRB00010804
NCI-2018-00556 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB00010804 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Neoplasms