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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Mismatched Related Donor versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults with Acute Leukemia or Myelodysplastic Syndrome

Multiple Cancer Types

This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using mismatched related donors (haploidentical [haplo]) versus matched unrelated donors (MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy or radiation therapy, which is intended to kill cancer cells that may be resistant to more standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the bone marrow, including stem cells. After the treatment, patients must have a healthy supply of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood cell production process in the bone marrow. The healthy stem cells may come from the blood or bone marrow of a related or unrelated donor. If patients do not have a matched related donor, doctors do not know what the next best donor choice is or if a haplo related donor or MUD is better. This trial may help researchers understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS is better or if there is no difference at all.
Leukemia, Myelodysplastic Syndrome, Pediatric Leukemia, Pediatric Lymphoma, Pediatrics
III
Kitko, Carrie
NCT05457556
COGASCT2031

Testing the Use of Steroids and Tyrosine Kinase Inhibitors with Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults

Leukemia

This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager (BiTE) that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
Leukemia
III
Mohan, Sanjay
NCT04530565
ECOGHEMEA9181

Decitabine and Cedazuridine in Combination with Venetoclax for the Treatment of Patients who have Relapsed Acute Myeloid Leukemia after Donor Stem Cell Transplant

Leukemia

This phase II trial tests how well decitabine and cedazuridine (DEC-C) works in combination with venetoclax in treating acute myeloid leukemia (AML) in patients whose AML has come back after a period of improvement (relapse) after a donor stem cell transplant. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving DEC-C in combination with venetoclax may kill more cancer cells in patients with relapsed AML.
Leukemia
II
Mohan, Sanjay
NCT05799079
VICCHEM2163

Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study

This study will validate a previously developed pediatric prognostic biomarker algorithm
aimed at improving prediction of risk for the later development of chronic graft-versus-host
disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell
transplant.

By developing an early risk stratification of patients into low-, intermediate-, and
high-risk for future cGvHD development (based upon their biomarker profile, before the onset
of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed
based upon an individual's biological risk profile.

This study will also continue research into diagnostic biomarkers of cGvHD, and begin work
into biomarker models that predict clinical response to cGvHD therapies.
Not Available
N/A
Kitko, Carrie
NCT04372524
VICCPED2183

INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

Miscellaneous

This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and
tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in
combination with ruxolitinib in participants with MF who are transfusion-dependent or
presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and
expansion.
Miscellaneous
I/II
Mohan, Sanjay
NCT04455841
VICCHEMP2051

Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

Multiple Cancer Types

This is a global, multicenter Phase 1/3 study to evaluate the efficacy and safety of
selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-nave myelofibrosis (MF)
participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3
(double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and
recommended dose (RD) of selinexor in combination with ruxolitinib and included a dose
escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). In
Phase 3, JAKi treatment-nave MF participants are enrolled in 2:1 ratio to receive the
combination therapy of selinexor + ruxolitinib or the combination of placebo + ruxolitinib.
Hematologic, Phase I
I/II
Mohan, Sanjay
NCT04562389
VICCHEMP2130

Acalabrutinib for the Treatment of Chronic Graft Versus Host Disease

Miscellaneous

This phase II trial studies how well acalabrutinib works in treating patients with chronic graft versus host disease. Acalabrutinib may be an effective treatment for graft-versus-host disease caused by a stem cell transplant.
Miscellaneous
II
Kitko, Carrie
NCT04198922
VICCCTT2122

Vorinostat in Preventing Graft Versus Host Disease in Children, Adolescents, and Young Adults Undergoing Blood and Bone Marrow Transplant

Multiple Cancer Types

This phase I/II trial studies the side effects and best dose of vorinostat in preventing graft versus host disease in children, adolescents, and young adults who are undergoing unrelated donor blood and bone marrow transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells, called graft-versus-host disease. During this process, chemicals (called cytokines) are released that may damage certain body tissues, including the gut, liver and skin. Vorinostat may be an effective treatment for graft-versus-host disease caused by a bone marrow transplant.
Hematologic, Pediatric Leukemia, Pediatric Lymphoma
I/II
Kitko, Carrie
NCT03842696
VICCPED2133

An Open Label, Expanded Access Protocol using 131I-Metaiodobenzylguanidine (131I-MIBG) Therapy in Patients with Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma

Multiple Cancer Types

Neuroblastoma (Pediatrics), Pediatric Solid Tumors
N/A
Kitko, Carrie
NCT01590680
VICCPED1249

Treatment Response and Biomarker-Guided Steroid Taper for Children with GVHD

Multiple Cancer Types

This phase II trial studies the treatment response for patients with acute graft-versus-host disease (GVHD). GVHD occurs when donor immune cells attack the healthy tissue of a bone marrow or stem cell transplant patient. The standard treatment for GVHD is to lower the activity of the donor cells by using steroid medications such as prednisone. But steroid treatment may cause many complications and the risk of these complications increases with higher doses of steroids and longer treatment. It is important to find ways to decrease the steroid treatment in patients who do not need long courses. Researchers are doing this study to find out how many subjects respond well to lower steroid dosing based on a blood test (GVHD biomarker) and if they develop fewer complications.
Miscellaneous, Pediatrics
II
Kitko, Carrie
NCT05090384
VICCPED2213

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