Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    20
  • sponsor
    Dartmouth-Hitchcock Medical Center
Updated on 24 January 2021
cancer
chronic myeloid leukemia
stem cell transplantation
myeloid leukemia
lymphoid leukemia
total body irradiation
fludarabine
tacrolimus
cyclophosphamide
chronic lymphocytic leukemia
lymphoma
myelofibrosis
multiple myeloma
hodgkin's disease
acute leukemia
myeloproliferative disorder
myelodysplasia
filgrastim
carbon monoxide
ejection fraction
waldenstrom's macroglobulinemia
granulocyte colony stimulating factor
hepatitis b
leukemia
lymphocytic leukemia
serum bilirubin level
colony stimulating factor
neutrophil count
g-csf
non-hodgkin's lymphoma
cellcept
chronic leukemia
immune regulators

Summary

The standard Johns Hopkins' regimen will be used in study subjects, with the use of donor peripheral blood stem cells, rather than marrow. Clinical outcomes will be defined while focusing efforts on immune reconstitution focusing on immune checkpoint regulators after a related haploidentical stem cell transplant.

Details
Condition Monoclonal gammopathy, Lymphoma, Preleukemia, Acute myeloid leukemia, Myelosclerosis with myeloid metaplasia, Lymphoproliferative Disorder, Lymphoma, Chronic Lymphocytic Leukemia, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, Chronic myeloid leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Myeloproliferative Neoplasms, Myelofibrosis, Lymphoproliferative disorders, myelodysplasia, myelodysplastic syndromes, myeloproliferative neoplasm, myeloproliferative disorders, non-hodgkin's lymphoma (nhl), plasma cell dyscrasia, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, lymphomas, myelodysplastic syndrome (mds), acute myelogenous leukemia, anll, acute myeloblastic leukemia, chronic myelogenous leukemia
Treatment G-CSF, cyclophosphamide, Fludarabine, Tacrolimus, Total body irradiation, CellCept, Peripheral Blood Transplant
Clinical Study IdentifierNCT03480360
SponsorDartmouth-Hitchcock Medical Center
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic Lymphocytic Leukemia or Myelofibrosis or Monoclonal gammopathy or MYELODYSPLASTIC SYNDROME or Lymphocytic Leukemia, Chronic or Preleukemia or ...?
Do you have any of these conditions: Monoclonal gammopathy or small lymphocytic lymphoma or lymphomas or plasma cell dyscrasia or myelodysplasia or Lymphoproliferative disorders or acute ...?
Age: less than 75 years
The patient must be approved for transplant by the treating transplant physician. This includes completion of their pre-transplant workup, as directed by standard Dartmouth-Hitchcock Medical Center (DHMC) Standard Operating Procedure (SOP) (DHMC SOP
Pre-transplant Evaluation of allogeneic recipient (Appendix)
The patient must have a disease (listed below) with treatment-responsiveness that the treating transplant physician believes will benefit from an allogeneic stem cell transplant. The diseases include
Acute leukemia - Acute Myeloid Leukemia, Acute Lymphocytic Leukemia
Chronic leukemia - Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia
Myelodysplasia
Myeloproliferative disorder
Myelofibrosis
Lymphoma - Non-Hodgkin's Lymphoma or Hodgkin's disease
Plasma cell disorder, including myeloma, Waldenstrom's Macroglobulinemia
Donor availability- the patient must have an identified RELATED haplo-identical donor
No Human Immunodeficiency Virus infection or active hepatitis B or C
Eastern Cooperative Oncology Group performance status: 0-2
Diffusing capacity of carbon monoxide (DLCO) greater than or equal to 40 % predicted
Left ventricular ejection fraction greater than or equal to 40%
Serum bilirubin < 2x upper limit of normal; transaminases < 3x normal at the time of transplant
No active or uncontrollable infection
In female, a negative pregnancy test if experiencing menstrual periods
No major organ dysfunction precluding transplantation
No evidence of an active malignancy that would limit the patient's survival to less than 2 years. (If there is any question, the PI can make a decision)

Exclusion Criteria

Psychiatric disorder or a mental deficiency of the patient that is sufficiently severe to make compliance with the treatment unlikely, and making informed consent impossible
Major anticipated illness or organ failure incompatible with survival from bone marrow transplant
History of refractory systemic infection
DONOR ELIGIBILITY
Human leukocyte antigen (HLA) haplo-identical matched related
The donor must be healthy and must be willing to serve as a donor, based on standard National Marrow Donor Program (NMDP) guidelines and DHMC SOP - Donor Evaluation (Appendix)
The donor must have no significant co-morbidities that would put the donor at marked increased risk
There is no age restriction for the donor
Informed consent must be signed by donor
DONOR EXCLUSION CRITERIA
The NMDP guidelines for exclusion criteria will be used (Appendix). In addition, the following donors are NOT eligible
Pregnant or lactating donor
HIV or active Hep B or C in the donor
Donor unfit to receive G-CSF and undergo apheresis
A donor with a psychiatric disorder or mental deficiency that makes compliance with the procedure unlikely and informed consent impossible
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