Status:
ACTIVE_NOT_RECRUITING
Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 i...
Detailed Description
We propose a clinical trial to define clinical endpoints, including engraftment, 100-day survival and one year survival (Objective #1). We will characterize the incidence, prevalence and function of i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03480360
Start Date
March 28 2018
End Date
September 13 2025
Last Update
July 23 2024
Active Locations (1)
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1
Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756