Lymphoma Clinical Trial
Official title:
Umbilical Cord Blood Transplant With Co-Infusion of T Regulatory Cells
Verified date | November 2017 |
Source | Masonic Cancer Center, University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body
irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of
cancer or abnormal cells and prepares the patient's bone marrow for the stem cells. When the
healthy stem cells from a donor are infused into the patient they may help the patient's bone
marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem
cells may replace the patient's immune cells and help destroy any remaining cancer or
abnormal cells (graft-versus-tumor effect). Giving an infusion of the donor's T-regulatory
cells before the transplant may help increase this effect. Sometimes the transplanted cells
from a donor can make an immune response against the body's normal cells. Giving cyclosporine
and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects and best dose of umbilical cord
blood T-regulatory cell infusion followed by donor umbilical cord blood transplant in
treating patients with high-risk leukemia or other hematologic diseases.
Status | Terminated |
Enrollment | 3 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: Patient and Donor Demographic Criteria - Patient must be 18-45 years of age. - Patients must have three partially HLA matched UCB units. Units identified as the HSC source must be HLA matched at 4-6 HLA- A and B (at low to intermediate resolution) and DRB1 (at high resolution), and the units must be HLA matched at 4-6 HLA- A, B, DRB1 antigens with each other. Total cryopreserved HSC graft cell dose must be >2.5 x 107 nucleated cells per kilogram recipient body weight. Also, the two umbilical cord blood (UCB) units must be ABO-matched. - The UCB unit identified as the Treg source must be HLA matched at 4-6 HLA antigens with the patient (without an HLA or ABO matching criterion with the UCB HSC source). Disease Criteria - Patients must have a hematological malignancy as listed below: - Acute myelogenous leukemia: high risk CR1 (as evidenced by preceding myelodysplastic syndrome (MDS), high risk cytogenetics such as those associated with MDS or complex karyotype, or >2 cycles to obtain complete remission (CR); second or greater CR. Must be in remission by morphology (<5% blasts within normocellular marrow). - Acute lymphocytic leukemia: high risk CR1 as evidenced by high risk cytogenetics [t(9;22), t (1:19), t(4;11) or other MLL rearrangements] or > 1 cycle to obtain CR; second or greater CR. - Chronic myelogenous leukemia resistant to imatinib therapy - Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics. Blasts must be < 10% by a representative bone marrow aspirate morphology (otherwise induction chemotherapy to achieve < 10% blasts is required pre-transplant). - Advanced myelofibrosis - Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma or follicular lymphoma that have progressed after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant. - Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy in CR1+ or PR1+. - Large cell non-Hodgkins lymphoma (NHL) > CR2/> PR2. Patients in CR2/PR2 with initial short remission(<6 months) are eligible. - Lymphoblastic lymphoma, Burkitt's lymphoma, and other high-grade NHL after initial therapy if stage III/IV in CR1/PR1 or after progression if stage I/II <1 year. - Multiple myeloma beyond PR2. Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or ß-2 microglobulin > 3 mg/L, may be considered for this protocol after initial therapy. - Recipients will have a Karnofsky score > 80% and have acceptable organ function ie creatinine < 2.0, bilirubin, AST/ALT, ALP < 2 x normal, pulmonary function > 50% normal, left ventricular ejection fraction > 45%. Note: All patients with a creatinine > 1.2 or a history of renal dysfunction must have creatinine clearance (must be > 40 ml/min to be eligible). - Recipients will sign informed consent approved by the Committee on the Use of Human Subjects at the University of Minnesota. Exclusion Criteria: - Pregnant or breastfeeding - Evidence of HIV infection or known HIV positive serology - Current active infection - Available HLA matched sibling donor. - CML in active blast crisis |
Country | Name | City | State |
---|---|---|---|
United States | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Masonic Cancer Center, University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose of T-regulatory cells | Dose limiting toxicities (DLT) are defined as any grade 3-4 toxicity within 24 hours of Treg cell infusion, excluding hematological . | Within 24 Hours | |
Secondary | Incidence of neutrophil recovery | Day 42 | ||
Secondary | Incidence of double chimerism | Day 21 | ||
Secondary | Incidence of grades II-IV and III-IV acute graft-versus-host disease (GVHD) | Day 100 | ||
Secondary | Incidence of chronic graft-versus-host disease | 1 Year | ||
Secondary | Survival | Day 100 and 1 Year | ||
Secondary | Incidence of Platelet Recovery | Day 180 |
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