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



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Lymphoma, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 75
Updated:3/24/2019
Start Date:March 28, 2018
End Date:December 31, 2022
Contact:Research Nurse
Email:cancer.research.nurse@dartmouth.edu
Phone:(800) 639-6918

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Haploidentical Allogeneic Peripheral Blood Transplantation: Clinical Trial and Laboratory Correlates Examining Checkpoint Immune Regulators' Expression

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.


Inclusion Criteria:

- 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
We found this trial at
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Lebanon, New Hampshire 03756
Phone: 800-639-6918
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