Leukemia Clinical Trial
Official title:
Radiolabeled BC8 (Anti-CD45) Antibody Combined With Cyclophosphamide and Total Body Irradiation Followed by HLA-matched Related or Unrelated Stem Cell Transplantation as Treatment for Advanced Acute Myeloid Leukemia and Myelodysplastic Syndrome
RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and either kill them
or deliver radioactive cancer-killing substances to them without harming normal cells. Drugs
used in chemotherapy work in different ways to stop cancer cells from dividing so they stop
growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Donor stem
cell transplantation may be able to replace immune cells that were destroyed by radiolabeled
monoclonal antibody therapy, chemotherapy and radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of combining radiolabeled monoclonal
antibody with cyclophosphamide and total-body irradiation followed by donor stem cell
transplantation in treating patients who have advanced acute myeloid leukemia.
OBJECTIVES:
- Determine the efficacy, in terms of overall survival and disease-free survival, and
toxicity of cyclophosphamide and total body irradiation in patients with acute myeloid
leukemia beyond first remission receiving HLA-matched related or unrelated
hematopoietic stem cell transplantation.
- Determine the maximum tolerated dose (MTD) of iodine I 131 monoclonal antibody BC8
(I131 MOAB BC8) in these patients.
- Estimate the MTD of radiation delivered by I 131 MOAB BC8 to marrow of these patients
and assess the effects on growth of marrow stroma in vitro.
OUTLINE: This is radiation dose-escalation study. Patients are stratified according to
available donor (related vs unrelated).
Patients receive a biodistribution dose of iodine I 131 monoclonal antibody BC8 (I131 MOAB
BC8) IV, then a therapeutic dose of I131 MOAB BC8 IV 6-14 days later (day -12). Patients
undergo total body irradiation twice daily on days -6 to -4. Patients receive
cyclophosphamide IV on days -3 and -2. Bone marrow cells (or peripheral blood stem cells)
are infused on day 0.
Patients with CNS leukemic involvement receive intrathecal methotrexate twice before the
transplantation then every other week for 8 weeks beginning on day 32. These patients also
receive cranial irradiation beginning on day 32.
Cohorts of 4 patients each receive escalating doses of iodine I 131 attached to a standard
dose of monoclonal antibody BC8 until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the radiation dose preceding that at which 2 of up to 6 patients
experience graft failure.
Patients are followed at 6, 9, and 12 months, every 6 months for 1 year, and then annually
thereafter.
PROJECTED ACCRUAL: A total of 40 patients (20 per stratum) will be accrued for this study
within 4 years.
;
Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05691608 -
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
|
N/A | |
Recruiting |
NCT04092803 -
Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu
|
N/A | |
Active, not recruiting |
NCT02530463 -
Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome
|
Phase 2 | |
Completed |
NCT00948064 -
Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
|
Phase 2 | |
Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Recruiting |
NCT03948529 -
RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation
|
Phase 2 | |
Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT02723994 -
A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
|
Phase 2 | |
Terminated |
NCT02469415 -
Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS)
|
Phase 2 | |
Recruiting |
NCT04856215 -
90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia
|
Phase 2 | |
Recruiting |
NCT06155188 -
Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia
|
N/A | |
Completed |
NCT00001637 -
Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
|
Phase 2 | |
Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
Completed |
NCT02910583 -
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
|
Phase 2 | |
Completed |
NCT01212926 -
Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain
|
N/A | |
Terminated |
NCT00014560 -
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
Recruiting |
NCT05866887 -
Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
|
N/A |