Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Phase II Trial of Inhibition of CD26 Peptidase Using Sitagliptin to Enhance Engraftment After Umbilical Cord Blood Transplantation for Adults With Hematological Malignancies
Verified date | February 2016 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The main purpose of this trial is to study whether the drug sitagliptin can be given safely to patients undergoing umbilical cord blood transplantation to speed up engraftment (recovery of blood counts after transplant).
Status | Completed |
Enrollment | 29 |
Est. completion date | February 2015 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 59 Years |
Eligibility |
Inclusion Criteria: - Patients must have one of the following disease types with disease-specific features as outlined in the protocol: - Acute myeloid leukemia (AML) - Acute lymphoblastic leukemia (ALL) - Myelodysplasia - Chronic myelogenous leukemia - Patients with aggressive non-Hodgkin's lymphoma (NHL), including diffuse large cell lymphoma, mediastinal B-cell lymphoma, transformed lymphoma, mantle cell lymphoma, and peripheral T cell lymphoma - Hodgkin's lymphoma - Relapsed Multiple Myeloma - At least 35 days following start of preceding leukemia induction cytotoxic chemotherapy - Patient age 18-55 years - Karnofsky Performance status = 70% - No availability of a consenting HLA-matched related donor who is either matched fully matched or mismatched at only one locus of HLA-A, -B, and DRB1. - No availability of a readily available HLA-matched volunteer unrelated donor (8 of 8 allele match at HLA-A, -B, -C and -DRB1). Patients with unstable disease who are in danger of significant disease progression while waiting to procure volunteer donor cells will be eligible to be treated on this protocol, even if a matched donor is available. - Patients must have a matched or partially matched UCB unit with greater than 1.8 x10-7 nucleated cells/kg of recipient weight at the time of cryopreservation. - No current uncontrolled bacterial, viral or fungal infection (defined as currently taking medication and progression of clinical symptoms). - No HIV disease. Patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies. - Non pregnant and non-nursing. Treatment under this protocol would expose a fetus to significant risks. - Required baseline laboratory values as defined in the protocol Exclusion Criteria: - Symptomatic uncontrolled coronary artery disease or congestive heart failure. - Severe hypoxemia with room air PaO2 less than 70, supplemental oxygen dependence, or DLCO less than 50 percent predicted - Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy - Prior allogeneic or autologous hematopoietic stem cell transplant in the last 6 months |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | IU Simon Cancer Center | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the efficacy of CD26/DPP-IV inhibition in increasing the proportion of adult patients with hematological malignancies engrafting by day +30 following transplantation of UCB by 30 percent. | Transplant (Day 0) through Day +100 | No | |
Secondary | Define the median times to neutrophil and platelet engraftment | Day 0 through Day +100 | No | |
Secondary | Describe rate of engraftment failure by day +100 | Day 0 through Day +100 | No | |
Secondary | Describe the incidence of grade 3 and 4 non-hematological toxicity | Day 0 through Day +100 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Recruiting |
NCT05772000 -
Clinical Significance of Occult Central Nervous System Localization
|
||
Recruiting |
NCT05618041 -
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
|
N/A | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Active, not recruiting |
NCT03114865 -
A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06308588 -
Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
|
Phase 2 | |
Recruiting |
NCT05579132 -
A Phase Ib/II Study of CN201 in Precursor B-cell Acute Lymphoblastic Leukemia
|
Phase 1/Phase 2 | |
Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
Terminated |
NCT02231853 -
Phase I/II Trial of Early Infusion of Rapidly-generated Multivirus Specific T Cells (MVST) to Prevent Post Transplant Viral Infections
|
Phase 1 | |
Recruiting |
NCT04969601 -
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings
|
Phase 1/Phase 2 | |
Recruiting |
NCT06195891 -
Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
Withdrawn |
NCT02815059 -
Study of Pts With Philadelphia Chromosome-Pos ALL With Comb of Ibrutinib, Dasatinib, and Prednisone
|
Phase 1 | |
Completed |
NCT00390793 -
Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.
|
Phase 2 | |
Recruiting |
NCT05866887 -
Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
|
N/A | |
Completed |
NCT00026780 -
Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
|
||
Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
Not yet recruiting |
NCT06350994 -
Early Assessment of Cardiac Function After Treatment With CAR-T Cells
|
||
Withdrawn |
NCT04282174 -
CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies
|
Phase 2 | |
Not yet recruiting |
NCT04488237 -
Vitamin D and Methotrexate Adverse Effects
|
||
Completed |
NCT02544438 -
Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
|
Phase 1/Phase 2 |