Intra-Osseous Co-Transplant of UCB and hMSC
Completed · Early Phase 1
Conditions studied: Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndromes, Myelofibrosis, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Lymphoid Malignancies, Chronic Myelogenous Leukemia
In brief
This clinical trial studies intra-osseous donor umbilical cord blood and mesenchymal stromal cell co-transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy and total-body irradiation before a co-transplant of donor umbilical cord blood and mesenchymal stromal cells into the bone (intra-osseous) helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil at the time of transplant may stop this from happening.
Key facts
- Study ID
- NCT02181478
- Run by
- Case Comprehensive Cancer Center
- People needed
- 6
- Starts
- 2015-07-22
- Expected to finish
- 2020-02-07
- Last updated by the study team
- 2020-12-04
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have one of the following malignancies:
- Acute myelogenous leukemia (AML): high-risk AML including:
- Antecedent hematological disease (e.g., myelodysplasia [MDS])
- Treatment-related leukemia
- Complete remission (first complete remission [CR1]) with poor-risk cytogenetics or molecular markers (e.g. fms-related tyrosine kinase 3 [Flt 3] mutation, 11q23, del 5, del 7, complex cytogenetics)
- Second complete remission (CR2) or third complete remission (CR3)
- Induction failure or first relapse with either
- ≤ 10% blasts in the marrow and/or
- ≤ 5% blasts in the peripheral blood
- Acute lymphoblastic leukemia (ALL)
- High-risk CR1 including:
- Poor-risk cytogenetics (e.g., Philadelphia chromosome t(9;22)or 11q23 rearrangements)
- Presence of minimal disease by flow cytometry after 2 or more cycles of chemotherapy
- No complete remission (CR) within 4 weeks of initial treatment
- Induction failure
- CR2 or CR3 with either:
- ≤ 10% blasts in the marrow and/or
- ≤ 5% blasts in the peripheral blood
- Myelodysplastic syndromes (MDS), Intermediate-1 (INT-1), intermediate-2 (INT-2) or high Revised International Prognostic Scoring System (IPSS-R) score that has failed at least 1 first line therapy
- Myelofibrosis (MF):
- Intermediate-2 or high risk by Dynamic International Prognostic Scoring System (DIPSS)-plus
- Monosomal karyotype
- Presence of inv(3)/i(17q) abnormalities
- Other unfavorable karyotype OR leukocytes ≥40 X 10\^9/L AND
- Circulating blasts ≤ 9%
You may not qualify if…
- Patients with inadequate Organ Function as defined by:
- Creatinine clearance < 30 ml/min
- Bilirubin ≥ 2 x institutional upper limit of normal
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≥ 2 x institutional upper limit of normal
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≥ 2 x institutional upper limit of normal
- Corrected diffusing capacity of the lung for carbon monoxide (DLCOcorr) < 40% normal
- Left ventricular ejection fraction < 35%
- Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breastfeeding women are excluded from this study
Where it is running
- Case Comprehensive Cancer Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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