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Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03480360
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dartmouth-Hitchcock Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kenneth Meehan, MD
Principal Investigator Affiliation Dartmouth-Hitchcock Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Chronic Myeloid Leukemia, Myelodysplasia, Myeloproliferative Disorder, Myelofibrosis, Lymphoma, Lymphoma, Non-Hodgkin, Plasma Cell Disorder
Additional Details

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 immune checkpoint regulators in patients' blood and bone marrow following transplantation (Objective #2). We will correlate these laboratory results with clinical outcomes and the incidence of GVHD. As an exploratory aim, in those patients experiencing GVHD and requiring treatment, we will define the frequency/expression of checkpoint regulator expression and correlate these results with the patient's response to GVHD therapy.

Arms & Interventions

Arms

Other: Johns Hopkins' conditioning regimen

Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant

Interventions

Drug: - Cyclophosphamide

14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)

Drug: - Fludarabine

30 mg/m2 daily for 5 days

Radiation: - Total Body Irradiation

200 centigray (cGy) for one day (day -1)

Drug: - Tacrolimus

1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.

Drug: - cellcept

dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.

Drug: - g-csf

5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) > 1000/mcL for 3 days.

Procedure: - Peripheral Blood Transplant

cell dose goal: < 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756

Site Contact

Research Nurse

cancer.research.nurse@dartmouth.edu

800-639-6918

Nearest Location

Site Contact

Research Nurse

cancer.research.nurse@dartmouth.edu

800-639-6918

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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