Acute Myelogenous Leukemia Clinical Trial
Official title:
A Phase I Study to Assess the Safety and Early Efficacy of TBX-2400 in Enhancing Engraftment in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of Acute Myelogenous Leukemia or Myelofibrosis
This is a study of allogeneic stem cell transplantation with TBX-2400 in adult subjects with Acute Myelogenous Leukemia (AML) or Myelofibrosis (MF). The donor cells are exposed to a protein that has been shown in the laboratory to improve the ability of the donor cells to make blood and immune cells after transplant. Exposure of the donor cells to this protein does not modify the genes in the cells in any way. This study has two goals. The first goal is to find out if transplant with TBX-2400 is safe. The second goal is to find out what effects TBX-2400 stem cells have on time to engraftment in adult subjects with AML or MF. The study hypothesis is that TBX-2400 cells will shorten the time to immune reconstitution after transplant.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | October 28, 2024 |
Est. primary completion date | August 28, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. For crAML: AML with =5% blasts (either by morphology or by multi-parameter flow cytometry [MFC]) in a marrow aspirate obtained within 21 days of enrollment in the trial, and following the administration of at least two prior courses of chemotherapy; 2. For MF: primary MF or MF that has progressed from a myeloproliferative disease. Dynamic International Prognostic Scoring System (DIPSS)-plus to be utilized to support the inclusion of MF subjects at screening; 3. Subject undergoing allogeneic stem cell transplantation on the decision of transplanting physician; 4. Signed informed consent of donor and recipient; 5. Subjects of = 18 years of age (no upper age limit); 6. Donor agrees to donate bone marrow-derived or mobilized peripheral blood stem cells; 7. Subjects with Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2; 8. Adequate pulmonary function with Diffusing Capacity for Carbon Monoxide (DLCO) > 50; 9. Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception (e.g. sterilization, hormone implants, hormone injections, intrauterine devices, or vasectomized partner with combined use of condom and/or birth control pills) from screening until 6 months after TBX-2400 transplantation; 10. Able to adhere to all trial treatments and procedures. Exclusion Criteria: 1. Previous stem cell transplantation; 2. For MF: Blasts > 10% in a marrow aspirate obtained within 30 days of screening; 3. Renal function: serum creatinine > 1.5 x Upper Limit of Normal (ULN); 4. Hepatic function: impaired synthetic function as indicated by a serum fibrinogen below the normal limit. Aspartate transaminase/alanine transaminase (AST/ALT) > 3.0 x ULN. Bilirubin, > 1.5 x ULN; 5. Cardiac function: ejection fraction < 45% as determined by echocardiography; 6. Prior malignancy active within previous three years - except for locally curable cancers such as cutaneous basal or squamous cell cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, or carcinoma in situ of the prostate; 7. Positive pregnancy test or breastfeeding for women of childbearing age; 8. Serologic evidence of chronic Hepatitis B virus infection or Hepatitis C exposure; 9. Known history of positive test for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS); 10. Hypersensitivity to any trial medication (including the preparative regimen, TBX-2400 treatment and any prophylaxis or other medication planned); 11. Presence of a serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with trial participation or trial drug administration, impair the ability of the participant to receive protocol therapy, or interfere with interpretation of trial results. |
Country | Name | City | State |
---|---|---|---|
Croatia | University Hospital Centre Zagreb | Zagreb | |
Italy | Fondazione Policlinico Universitario Agostino Gemelli | Roma |
Lead Sponsor | Collaborator |
---|---|
Taiga Biotechnologies, Inc. |
Croatia, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events according to NCI-CTCAE Version 5.0 | Adverse events from subject reporting or other assessments | Two years | |
Primary | Transplant engraftment | Assessment of transplant engraftment will include absolute neutrophil count, untransfused platelet count and donor chimerism | 1 year | |
Secondary | Immune reconstitution as measured by CD3+ cell count | Immune reconstitution as measured by CD3+ cell count > 300/µL | Up to Day 360 | |
Secondary | Immunoglobulin (IgA) levels | Up to Day 360 | ||
Secondary | Immunoglobulin (IgM) levels | Up to Day 360 | ||
Secondary | T-cell Engraftment | CD45 RA versus RO at 3, 6, 9 and 12 months | Up to Day 360 | |
Secondary | Disease-free survival | Two years | ||
Secondary | Incidence of secondary graft failure | Two years | ||
Secondary | Transplant-Related Mortality (TRM) | 100 Days | ||
Secondary | Quality of life using the World Health Organisation Five Wellbeing Index | QoL assessed at 3, 6, 9 and 12 months (World Health Organization [WHO] Five Wellbeing Index). | Up to day 360 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01200355 -
Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome
|
Phase 4 | |
Active, not recruiting |
NCT03755414 -
Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation
|
Phase 1 | |
Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
Completed |
NCT02543879 -
Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies
|
Phase 1 | |
Completed |
NCT01681537 -
Lenalidomide Plus Chemotherapy for AML
|
Phase 1 | |
Completed |
NCT01385423 -
Haploidentical Donor Natural Killer Cell Infusion With IL-15 in Acute Myelogenous Leukemia (AML)
|
Phase 1 | |
Terminated |
NCT01193400 -
Clofarabine and Low-dose Cytarabine Followed by Consolidation Therapy in AML Patients Age Greater Than or Equal to 60 Years
|
Phase 2 | |
Completed |
NCT00975975 -
Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
|
Phase 2 | |
Completed |
NCT00995332 -
Disease Stabilization in AML by Treatment With ATRA, Valproic Acid and Low-dose Cytarabine
|
Phase 1/Phase 2 | |
Completed |
NCT00981240 -
Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes
|
Phase 1 | |
Completed |
NCT00726934 -
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
|
N/A | |
Completed |
NCT00378534 -
Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants
|
Phase 2 | |
Completed |
NCT01031498 -
Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting
|
Phase 2 | |
Completed |
NCT00789256 -
Low Dose Melphalan and Bortezomib for AML and High-Risk MDS
|
N/A | |
Completed |
NCT00098033 -
Investigation of Clofarabine in Acute Leukemias
|
Phase 2 | |
Completed |
NCT01020539 -
Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Leukemia
|
Phase 1 | |
Recruiting |
NCT04024241 -
Medium Dose of Cytarabine and Mitoxantrone
|
||
Terminated |
NCT02203773 -
Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)
|
Phase 1 | |
Terminated |
NCT04023071 -
FT516 in Subjects With Advanced Hematologic Malignancies
|
Phase 1 |