A Study of Experimental Treatment with OrcaGraft for Allogeneic (donor) Transplant in Hematologic Malignancies (blood cancers)

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 to 65 years old
Gender:
Any
Healthy Volunteers: No
Keywords: myeloablative allogeneic hematopoietic cell transplantation, hematologic malignancies, blood disoders, cell transplant, blood transfusion, blood donor, blood donation
Type: Biological study, Phase 1
Target:
15 Participants
Investigator:
Description
This research study will test if experimental OrcaGraft can be safely given to patients. It will be studied as a stem cell transplant in patients with blood cancers and pre-cancerous conditions.

We are doing this research because some transplants can cause complications. One complication is called graft-versus-host-disease (GVHD). GVHD causes donor cells to attack recipient tissues.

OrcaGraft is designed to minimize or eliminate potential complications and provide a safer transplant. This study will see if OrcaGraft is safe to use. We will also collect data about the best dose of cells that make up a part of OrcaGraft. This could provide data to make the composition of OrcaGraft better in the future. This study is being done at UC Davis Health and at other sites around the U.S.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  1. Age ≥ 18 and ≤ 65 years at the time of enrollment
  2. Diagnosed acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) or
  3. High or very high risk myelodysplasic syndrome (MDS) including both of the following:
  4. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (HCT)
  5. Matched to a related or unrelated donor or to a haploidentical donor
  6. Estimated glomerular filtration rate (eGFR) > 50 mL/minute
  7. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
  8. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
  9. Total bilirubin < 1.5 times upper limit of normal (ULN) (< 3 times if attributed to Gilbert's syndrome) and ALT/AST < 3 times ULN Key

Exclusion criteria:

  1. Prior allogeneic HCT
  2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
  3. Planned donor lymphocyte infusion (DLI)
  4. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor
  5. Karnofsky performance score < 70% (Appendix 12.7)
  6. Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4 (Appendix 12.8)
  7. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
  8. Seropositive for HIV-1 or -2, HTLV-1 or -2
  9. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
  10. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected
  11. History of idiopathic or secondary myelofibrosis
  12. Women who are pregnant or breastfeeding
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
If you agree, you will be in this study for about 13 months and will need to visit the research site about 15 times.
Recruitment period
From May 16, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndromes
  • Acute Leukemia