A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202)
Pediatrics
Pediatrics
Severe Aplastic Anemia (SAA) is a rare condition in which the body stops producing enough new
blood cells. SAA can be cured with immune suppressive therapy or a bone marrow transplant.
Regular treatment for patients with aplastic anemia who have a matched sibling (brother or
sister), or family donor is a bone marrow transplant. Patients without a matched family donor
normally are treated with immune suppressive therapy (IST). Match unrelated donor (URD) bone
marrow transplant (BMT) is used as a secondary treatment in patients who did not get better
with IST, had their disease come back, or a new worse disease replaced it (like leukemia).
This trial will compare time from randomization to failure of treatment or death from any
cause of IST versus URD BMT when used as initial therapy to treat SAA.
The trial will also assess whether health-related quality of life and early markers of
fertility differ between those randomized to URD BMT or IST, as well as assess the presence
of marrow failure-related genes and presence of gene mutations associated with MDS or
leukemia and the change in gene signatures after treatment in both study arms.
This study treatment does not include any investigational drugs. The medicines and procedures
in this study are standard for treatment of SAA.
blood cells. SAA can be cured with immune suppressive therapy or a bone marrow transplant.
Regular treatment for patients with aplastic anemia who have a matched sibling (brother or
sister), or family donor is a bone marrow transplant. Patients without a matched family donor
normally are treated with immune suppressive therapy (IST). Match unrelated donor (URD) bone
marrow transplant (BMT) is used as a secondary treatment in patients who did not get better
with IST, had their disease come back, or a new worse disease replaced it (like leukemia).
This trial will compare time from randomization to failure of treatment or death from any
cause of IST versus URD BMT when used as initial therapy to treat SAA.
The trial will also assess whether health-related quality of life and early markers of
fertility differ between those randomized to URD BMT or IST, as well as assess the presence
of marrow failure-related genes and presence of gene mutations associated with MDS or
leukemia and the change in gene signatures after treatment in both study arms.
This study treatment does not include any investigational drugs. The medicines and procedures
in this study are standard for treatment of SAA.
Pediatrics
III
Connelly, James
NCT05600426
VICCPED2295
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.
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/III
Mohan, Sanjay
NCT04562389
VICCHEMP2130
A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms
Leukemia
Leukemia
This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity
(DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion
(RDE) of INCA033989 administered in participants with myeloproliferative neoplasms.
(DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion
(RDE) of INCA033989 administered in participants with myeloproliferative neoplasms.
Leukemia
I
Mohan, Sanjay
NCT06034002
VICC-DTHEM23416P
A Phase 1 Study of AB521 in Renal Cell Carcinoma and Other Solid Tumors
Multiple Cancer Types
The purpose of this study is to evaluate the safety and tolerability of AB521 when taken
alone in participants with advanced solid tumor malignancies and clear cell renal cell
carcinoma (ccRCC).
alone in participants with advanced solid tumor malignancies and clear cell renal cell
carcinoma (ccRCC).
Kidney (Renal Cell),
Phase I
I
Rini, Brian
NCT05536141
VICC-DTURO23168P
Nivolumab and Ipilimumab for the Treatment of Patients with Locally Advanced, Metastatic, or Unresectable Liver Cancer
This phase II trial tests whether nivolumab and ipilimumab works to shrink tumors in patients with liver cancer that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Nivolumab and ipilimumab may be effective in killing tumor cells in patients with liver cancer.
Not Available
II
Not Available
NCT05199285
VICCGI2277
A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Multiple Cancer Types
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of
BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with
advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in
participants with advanced solid tumors.
BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with
advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in
participants with advanced solid tumors.
Bladder,
Colon,
Esophageal,
Gastric/Gastroesophageal,
Head/Neck,
Kidney (Renal Cell),
Lung,
Ovarian,
Pancreatic,
Urologic
I/II
Berlin, Jordan
NCT04895709
VICC-DTPHI23183
A Study Using a New Drug, Nivolumab, in Combination with Chemotherapy Drugs to Treat a Type of Cancer Called Nasopharyngeal Carcinoma (NPC)
This phase II trial tests how well nivolumab in combination with chemotherapy drugs along with radiation therapy works in treating patients with nasopharyngeal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Researchers want to find out what effects, good and/or bad, adding nivolumab to chemotherapy has on patients with newly diagnosed NPC. In addition, they want to find out if children with NPC may be treated with less radiation therapy and whether this decreases the side effects of therapy.
Not Available
II
Not Available
NCT06064097
VICC-NTPED24105
Durvalumab with Gemcitabine and Cisplatin for the Treatment of High Risk Resectable Liver Cancer Before Surgery
This phase II trial tests how well giving durvalumab with standard chemotherapy, gemcitabine and cisplatin, before surgery works in treating patients with high risk liver cancer (cholangiocarcinoma) that can be removed by surgery (resectable). Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab with gemcitabine and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed in patients with high risk resectable cholangiocarcinoma.
Not Available
II
Heumann, Thatcher
NCT06050252
ETCGI10608
P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies
Lymphoma
Lymphoma
Phase 1 study comprised of open-label, dose escalation and expansion cohort study of
P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with
relapsed/refractory B cell malignancies
P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with
relapsed/refractory B cell malignancies
Lymphoma
I
Dholaria, Bhagirathbhai
NCT06014762
VICC-DTCTT23163P
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
The safety, tolerability, and antileukemic response of ziftomenib in combination with
standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will
be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.
standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will
be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.
Not Available
I
Fedorov, Kateryna
NCT06001788
VICC-DTHEM23484P
