CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Cyclosporine +10 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01300572
NCT01300572Phase 1Completed

A Study Evaluating Escalating Doses of 90Y-DOTA-BC8 (Anti-CD45) Antibody Followed by Allogeneic Stem Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML) Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS)

Fred Hutchinson Cancer Center·interventional·Posted Feb 21, 2011·Updated Dec 10, 2019

In Brief

A Phase 1 clinical trial evaluating Allogeneic Bone Marrow Transplantation, Allogeneic Hematopoietic Stem Cell Transplantation, and 9 other interventions for Chronic Myelomonocytic Leukemia and 5 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed Summary

This phase I trial studies the side effects and maximum tolerated dose of yttrium Y 90 anti-cluster of differentiation 45 (CD45) monoclonal antibody BC8 (90Y-BC8) followed by donor stem cell transplant in treating patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) that is likely to come back or spread. Giving chemotherapy drugs, such as fludarabine phosphate (FLU), and total-body irradiation (TBI) before a donor peripheral blood stem cell (PBSC) or bone marrow transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies, such as 90Y-BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving FLU, 90Y-BC8, and TBI before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

Study Details

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 21, 2011
Enrollment StartJan 1, 2012
Primary CompletionOct 29, 2017
Study CompletionNov 22, 2019
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 15.4 years ago

Interventions

Allogeneic Bone Marrow Transplantationprocedure

Undergo allogeneic bone marrow transplant

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic PBSC or bone marrow transplant

Cyclosporinedrug

Given PO or IV

Fludarabine Phosphatedrug

Given IV

Indium In 111 Anti-CD45 Monoclonal Antibody BC8biological

Given IV (dosimetric dose)

Laboratory Biomarker Analysisother

Correlative studies

Mycophenolate Mofetildrug

Given PO or IV

Peripheral Blood Stem Cell Transplantationprocedure

Undergo allogeneic PBSC transplant

Pharmacological Studyother

Correlative studies

Total-Body Irradiationradiation

Undergo TBI

Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8radiation

Given via central line (therapeutic dose)