211At-BC8-B10 and Donor Stem Cell Transplant in Treating Relapsed or Refractory AML, ALL, or Myelodysplastic Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03670966|
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : October 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia in Remission Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Acute Myeloid Leukemia in Remission CD45-Positive Neoplastic Cells Present Chronic Myelomonocytic Leukemia High Risk Myelodysplastic Syndrome Myelodysplastic Syndrome With Excess Blasts Myeloproliferative Neoplasm Recurrent Acute Lymphoblastic Leukemia Recurrent Acute Myeloid Leukemia Refractory Acute Lymphoblastic Leukemia Refractory Acute Myeloid Leukemia||Biological: Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 Drug: Fludarabine Drug: Cyclophosphamide Radiation: Total-Body Irradiation Procedure: Peripheral Blood Stem Cell Transplantation Procedure: Bone Marrow Transplantation Drug: Tacrolimus Drug: Mycophenolate Mofetil Drug: Sirolimus Biological: Granulocyte Colony-Stimulating Factor||Phase 1 Phase 2|
OUTLINE: This is a dose-escalation study of astatine At 211 anti-CD45 monoclonal antibody BC8-B10.
PREPARATIVE REGIMEN: Participants receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 infusion on day -8, fludarabine intravenously (IV) over 30 minutes on days -6 to -2, and cyclophosphamide IV over 1 hour on days -6 and -5. Participants also undergo TBI on day -1.
TRANSPLANT: Participants undergo PBSC or bone marrow transplant on day 0.
GVHD PROPHYLAXIS: Participants receive cyclophosphamide IV over 1-2 hours on days 3-4, tacrolimus IV over 1-2 hours or orally (PO) on days 5-150 with a taper beginning on day 84, mycophenolate mofetil IV or PO on days 5-35, and sirolimus PO daily on days 5-180 with taper beginning on day 150. Participants also begin granulocyte colony-stimulating factor (G-CSF) IV or subcutaneously (SC) on day 5 to continue until absolute neutrophil count (ANC) > 1000/mm^3 X 3 days.
After completion of study treatment, participants are followed up at day 100, and at 6, 9, 12, 18, and 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study Evaluating Escalating Doses of 211At-Labeled Anti-CD45 MAb BC8-B10 (211At-BC8-B10) Followed by Related Haplo-Identical Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS)|
|Actual Study Start Date :||March 20, 2019|
|Estimated Primary Completion Date :||September 1, 2023|
|Estimated Study Completion Date :||September 1, 2024|
PREPARATIVE REGIMEN: Participants receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 infusion day -8, fludarabine IV over 30 minutes on days -6 to -2, and cyclophosphamide IV over 1 hour on days -6 and -5. Participants also undergo Total-Body Irradiation on day -1.
TRANSPLANT: Participants undergo Peripheral Blood Stem Cell Transplantation or Bone Marrow Transplantation day 0.
GVHD PROPHYLAXIS: Participants receive cyclophosphamide IV over 1-2 hours on days 3-4, tacrolimus IV over 1-2 hours or PO on days 5-150 with a taper beginning on day 84, mycophenolate mofetil IV or PO on days 5-35, and sirolimus PO daily on days 5-180 with taper beginning on day 150. Participants also begin Granulocyte Colony-Stimulating Factor IV or SC on day 5 to continue until ANC > 1000/mm^3 X 3 days
Biological: Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10
Given via infusion
Other Name: At 211 MAb BC8-B10
Other Name: 2-Fluoro-9-beta-arabinofuranosyladenine
Other Name: (-)-Cyclophosphamide
Radiation: Total-Body Irradiation
Procedure: Peripheral Blood Stem Cell Transplantation
Undergo PBSC transplantation
Other Name: PBPC transplantation
Procedure: Bone Marrow Transplantation
Undergo bone marrow transplant
Given IV or PO
Drug: Mycophenolate Mofetil
Given IV or PO
Biological: Granulocyte Colony-Stimulating Factor
Given IV or SC
- Toxicity [ Time Frame: Up 100 days after hematopoietic cell transplantation (HCT) ]Proportion of patients who develop grades III/IV Bearman regimen-related toxicity.
- Overall survival [ Time Frame: Up to 100 days ]
- Disease-free survival [ Time Frame: Up to day 100 ]
- Number of patients experiencing Moderate/severe chronic GVHD [ Time Frame: Up to 2 years ]
- Number of patients experiencing Number of Grade II-IV acute graft versus host disease (GVHD) [ Time Frame: Up to 2 years ]
- Number of patients experiencing Immune reconstitution [ Time Frame: Up to 2 years ]
- Non-relapse mortality (NRM) [ Time Frame: Up to 2 years ]
- Donor chimerism [ Time Frame: At days 28, 56, 84, 180, and at 1 year ]
- Rate of engraftment [ Time Frame: Up to 2 years ]
- Achievement of remission [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670966
|Contact: Phuong Vofirstname.lastname@example.org|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Phuong Vo|
|Principal Investigator: Phuong Vo|
|Principal Investigator:||Phuong Vo||Fred Hutchinson Cancer Research Center|