Acute Leukemia Clinical Trial
Official title:
Phase I/II Study Assessing Radioligand Therapy (RLT) Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia.
CXCR4 inhibition may represent a new therapeutic strategy in acute leukemia (AL) patients, not only by increasing chemosensitivity but also by preventing relapse of the disease by disruption of the interaction of residual leukemic cells with the bone marrow niche. Radiolabeled CXCR4 ligands have been developed for PET imaging (68Ga-PentixaFor; INN: Gallium (68Ga) boclatixafortide) and radioligand therapy (RLT) ([177Lu]Lu-PentixaTher/[90Y]Y-PentixaTher). [177Lu]Lu and [90Y]Y-PentixaTher have been tested in three multiple myeloma patients in named-patient use with a remarkable efficacy in 2 patients (Herrmann, 2016). Moreover, feasibility of CXCR4 PET imaging in AML was reported, providing a framework for future theranostic approaches targeting the CXCR4/CXCL12-defined leukemia-initiating cell niche (Herhaus, 2016). Here a Phase I/II study to determine maximal tolerated dose (MTD) of a RLT using [177Lu]Lu-PentixaTher in relapsed/refractory AL was designed. This will be a standard phase I/II 3+3 dose escalation study. Five dose levels will be tested, so 6 to 21 patients have to be included in the study.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05088356 -
Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
|
Phase 1 | |
| Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
| Recruiting |
NCT04969601 -
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02356159 -
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05170828 -
Cryopreserved MMUD BM With PTCy for Hematologic Malignancies
|
Phase 1 | |
| Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
| Active, not recruiting |
NCT01956630 -
Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT
|
Phase 1/Phase 2 | |
| Completed |
NCT00988013 -
Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
|
N/A | |
| Enrolling by invitation |
NCT01728402 -
Pathogenesis of Hematologic Malignancies
|
||
| Active, not recruiting |
NCT03595800 -
Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen
|
Phase 3 | |
| Completed |
NCT02440178 -
Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia
|
Phase 2 | |
| Recruiting |
NCT05071482 -
Flumatinib Versus Imatinib Combined With Chemotherapy for de Novo Ph+ ALL
|
Phase 4 | |
| Completed |
NCT03042676 -
Electronic Database for the Follow up of the ATG_FamilyStudy
|
||
| Withdrawn |
NCT03138395 -
iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML
|
N/A | |
| Completed |
NCT04597086 -
Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients
|
N/A | |
| Terminated |
NCT03588936 -
Nivolumab and Tocilizumab for Relapsed Hematological Malignancy Post-allogeneic Transplant
|
Phase 1 | |
| Recruiting |
NCT05521204 -
Olverembatinib for FGFR1-rearranged Neoplasms
|
Phase 2 | |
| Not yet recruiting |
NCT04084327 -
Immunophenotyping of Acute b Cell Lymphoblstic Leukemia
|
||
| Terminated |
NCT00852709 -
Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias
|
Phase 1 | |
| Not yet recruiting |
NCT06026839 -
Longitudinal Study on the QoL of Pediatric Patients After HSCT and Its Influencing Factors
|