Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
- - Radiation-based cohort diagnoses: - Acute myeloid leukemia.
- - Acute lymphoid leukemia in remission.
- - Myelodysplasia (MDS) - Chronic lymphocytic leukemia (CLL) with no or minimal lymph node involvement.
- - Multiple myeloma.
- - Chronic myeloid leukemia.
- - Myelofibrosis.
- - Myeloid malignancy not otherwise specified.
- - Chronic myelomonocytic leukemia.
- - Essential thrombocytopenia or polycythemia vera.
- - T cell leukemia.
- - T cell lymphoma without significant lymph node disease burden.
- - Any hematological malignancy or dyscrasia not cited above in which HSCT is potentially curable * Any patient who has a hematological disease that would normally be treated on a myeloablative study, but is prevented from doing so by factors in their past medical history.
- - Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered) - Chemotherapy-based cohort diagnoses: - Hodgkin or non-Hodgkin lymphoma.
- - Small lymphocytic lymphoma/CLL.
- - Any other diagnosis in which chemotherapy is thought to be superior to radiotherapy for treatment of the disease.
- - Hematological malignancy in patients who cannot receive > 2 Gy radiation * Aplastic anemia and other non-malignant hematologic dyscrasias.
- - Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered) - HLA identical cohort diagnoses: * Patients in this group will be treated in parallel to the radiation-based cohort or the chemotherapy-based group based on what category their diagnosis falls into.
- - Left ventricular ejection fraction of >= 50% - Diffusion lung capacity of oxygen >= 50% and forced expiratory volume at 1 second >= 50% of predicted corrected for hemoglobin.
- - Adequate liver function as defined by a serum bilirubin =< 1.8, aspartate aminotransferase or alanine aminotransferase =< 2.5 x upper limit of normal.
- - Creatinine clearance of >= 60 mL/min.
- - Patients must have adequate Karnofsky performance status (KPS) and hematopoietic cell transplantation-comorbidity index (HCT-CI) scores: - Patients < age 60 years must have a KPS of >= 80% and an HCT-CI score of 5 or less.
- - Patients aged 60 to 65 years must have a KPS of >= 80% and an HCT-CI score of 4 or less.
- - Patients aged 66 to 69 years must have a KPS of 90% and an HCT-CI score of 3 or less * Patients aged 70 years or more must have a KPS of 90% and an HCT-CI score of 2 or less.
- - (Patients with greater than the allowable HCT-CI points for age can be enrolled for trial with approval of the principal investigator and at least 1 co-investigator not on the primary care team of the patient).
- - Patients must be willing to use contraception if they have childbearing potential.
- - Patient or patient's guardian is able to give informed consent.
- - Patients should have a life expectancy of >= 6 months for reasons other than their underlying hematologic/oncologic disorder.
- - Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol.
- - Patients should not be: - Human immunodeficiency virus positive.
- - Have active involvement of the central nervous system with malignancy.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Thomas Jefferson University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aplastic Anemia, Chronic Lymphocytic Leukemia, Chronic Myelomonocytic Leukemia, Essential Thrombocythemia, Hematopoietic and Lymphoid Cell Neoplasm, Hodgkin Lymphoma, Myelodysplastic Syndromes, Myelofibrosis, Myeloid Leukemia, Myeloid Neoplasm, Non-Hodgkin Lymphoma, Plasma Cell Myeloma, Polycythemia Vera, Small Lymphocytic Lymphoma|
- I. To assess the 2 year cumulative incidence of TRM in patients undergoing reduced intensity conditioning (RIC) haploidentical (HI) HSCT in this protocol.
- I. To assess the 2 year cumulative incidence of relapse in patients undergoing RIC HI HSCT in this protocol.
- II. To assess the consistency and pace of engraftment.
- III. To assess the pace of T cell and B cell immune recovery.
- IV. To assess the incidence and severity of graft versus host disease (GVHD).
Experimental: Radiation-Based Cohort (fludarabine, TBI, infusion)
Patients receive fludarabine IV on days -11, -10, -9, and -8, undergo TBI BID on days -10 and -9, undergo DLI on day -6, and receive cyclophosphamide IV on days -3 and -2. Patients begin tacrolimus and mycophenolate mofetil IV on day -1. Patients then undergo HSCT on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.
Experimental: Chemotherapy-Based Cohort (fludarabine, melphalan, TBI)
Patients receive fludarabine IV on days -11, -10, -9, and -8 and melphalan IV on days -10 and -9. Patients undergo TBI and DLI once on day -6. Patients receive cyclophosphamide IV on days -3 and -2 and begin tacrolimus and mycophenolate mofetil on day -1. Patients undergo hematopoietic stem cell transplant on day 0.
Procedure: - Hematopoietic Cell Transplantation
Drug: - Mycophenolate Mofetil
Drug: - Tacrolimus
Drug: - Cyclophosphamide
Radiation: - Total-Body Irradiation
Procedure: - Donor Lymphocyte Infusion
Drug: - Fludarabine
Drug: - Melphalan
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.