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||N/A - 75 Years|
- - Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (< 16 years).
- - 5/6 or 6/6 related donor, OR a 7-8/8 HLA-A, B, C, DRB1 allele match, OR a haplotype (at least 5/10) matched related donor.
- - t(8,21) without cKIT mutation.
- - inv(16) or t(16;16) without cKIT mutation.
- - Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy) - Normal karyotype with double mutated CEBPA.
- - Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation.
- - Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1.
- - 30 years of age or older at diagnosis.
- - White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL) at diagnosis.
- - CNS leukemia involvement during the course of disease.
- - Slow cytologic response (>10% lymphoblasts in bone marrow on Day 14 of induction therapy) - Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy.
- - with transfusion dependence or expected survival under 5 years by DIPSS, DIPSS-plus, or MPSS70 calculator.
- - Pregnant or breast feeding.
- - Untreated active infection.
- - Active central nervous system malignancy.
- - CML in blast crisis.
- - Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy.
- - Less than 3 months since prior myeloablative transplant.
- - Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.
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.
|Masonic Cancer Center, University of Minnesota|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||University of Minnesota Masonic Cancer Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Biphenotypic Acute Leukemia, Undifferentiated Leukemia, Prolymphocytic Leukemia, Chronic Myelogenous Leukemia, Plasma Cell Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Myelodysplastic Syndrome With Excess Blasts-1, Burkitt Lymphoma, Relapsed T-Cell Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma, Follicular Lymphoma, Myeloproliferative Neoplasm, Myelofibrosis|
Experimental: Cy/Flu/TBI + Post transplant CY
Biological: - Peripheral Blood Stem Cell Transplant
On day 0, a target dose of 5 x 106 CD34 cells/kg will be infused.
Drug: - Allopurinol 300 MG
300 mg/day from day -7 to day 0. Allopurinol 150mg/m2/day for pediatric participants.
Drug: - Fludarabine
30 mg/m2 IV over 1 hour. Administered on day -6 to day -2.
Drug: - Cyclophosphamide
Administered as a 2 hour IV infusion on day -6, +3, and +4.
Biological: - Bone Marrow Cell Transplant
On day 0, a target dose of 3 x 108 nucleated cells/kg recipient weight will be infused.
Radiation: - Total Body Irradiation
The dose of TBI will be 200 cGy given in a single fraction on day -1.
Drug: - Sirolimus Pill
All participants begin +5 to day +100. Loading dose on day +5 of 5 mg/m2/day orally once (max dose of 8 mg). Maintenance dose 2.5 mg/m2 orally daily to maintain a level of 8-12 ng/ml (max dose of 4 mg).
Drug: - Mycophenolate Mofetil
All patients begin day +5 through day +35. 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 doses. In obese patients (>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patients will receive MMF at the dose of 15 mg/kg/dose (maximum of 1 gram per dose) every 8 hours.
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.