Mylotarg

DRUG10 trials

Conditions

Acute Myelogenous LeukemiaAcute Myeloid LeukemiaAcute Promyelocytic LeukemiaChronic Lymphocytic LeukemiaInfusions, IntravenousLeukemiaLeukemia, Myelocytic, AcuteLeukemia, Myeloid, Acute

Phase 1

Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS

CompletedNCT00038831

M.D. Anderson Cancer CenterAcute Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Myelodysplastic Syndrome

Start: 2001-05-31End: 2006-10-31Updated: 2012-08-01

DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML

CompletedNCT02182596

Acute Leukemia French AssociationAcute Myeloid Leukemia

Start: 2006-06-30End: 2011-01-31Updated: 2014-07-08

Allogeneic Engineered Hematopoietic Stem Cell Transplant (HCT) Lacking the CD33 Protein, and Post-HCT Treatment With Mylotarg, for Patients With CD33+ AML or MDS

TerminatedNCT04849910

Vor BiopharmaLeukemia, Myeloid, Acute, Myelodysplastic Syndromes

Start: 2021-12-16End: 2025-05-28Updated: 2025-07-29

Phase 2

Nonmyeloablative Preparative Regimen Using Mylotarg for Patients With High Risk Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myeloid Leukemia (CML) and Myelodysplastic Syndrome (MDS)

TerminatedNCT00038805

M.D. Anderson Cancer CenterLeukemia

Start: 2001-05-31End: 2004-11-30Updated: 2018-10-31

Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS

CompletedNCT00195000

Weill Medical College of Cornell UniversityAcute Myeloid Leukemia, Myelodysplastic Syndrome

Start: 2003-05-31End: 2008-02-29Updated: 2013-06-19

Prospective Study of Mylotarg and G-CSF in Acute Myeloid Leukemia Treatment

CompletedNCT01698879

Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y MielodisplasiasNovo Acute Myeloid Leukemia

Start: 2009-10-31End: 2016-09-26Updated: 2021-01-27

Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia

RecruitingNCT04793919

Associazione Italiana Ematologia Oncologia PediatricaAcute Promyelocytic Leukemia

Start: 2019-10-09End: 2027-10-10Target: 89Updated: 2024-04-15

Vyxeos for Induction of Low- or Intermediate-risk.

Active, not recruitingNCT05599360

Shaare Zedek Medical CenterLeukemia, Myeloid, Acute

Start: 2022-08-07End: 2028-09-07Updated: 2026-09-03

Phase 4

Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia

CompletedNCT00304447

Wyeth is now a wholly owned subsidiary of PfizerInfusions, Intravenous, Leukemia, Myelocytic, Acute

Start: 2002-04-30End: 2004-01-31Target: 30Updated: 2009-07-29

Unknown Phase

Study Evaluating Mylotarg (Gemtuzumab Ozogamicin) in Usual Care

CompletedNCT00161668

Wyeth is now a wholly owned subsidiary of PfizerAcute Myeloid Leukemia

Start: 2001-10-31Target: 500Updated: 2007-03-15

2026-08-05

CRISPR−Cas9 CD33-deleted allogeneic hematopoietic cell transplantation with gemtuzumab ozogamicin maintenance in AML: a phase 1/2 trial

Nature Medicine2026-05-12

Chemotherapy-free treatment for children and adolescents with newly diagnosed acute promyelocytic leukemia (APL): Results of the prospective ICC-APL-02 study.

Blood2025-11-03

A CD33-Deleted Allograft (Trem-cel) Enables Post-Hematopoietic Cell Transplant (HCT) Maintenance Dosing of Gemtuzumab Ozogamicin (GO) with Therapeutic Levels of Drug Exposure and Low Hematologic and Hepatic Toxicity in Patients with High-Risk Acute Myeloid Leukemia (AML)

Blood2024-11-052 citations

Genome editing in clinical practice: A model study for next-gen hematopoietic cell transplants in hematologic malignancies

Molecular Therapy — Methods & Clinical Development2024-02-26

Trem-Cel, a CRISPR/Cas9 Gene-Edited Allograft Lacking CD33, Shows Rapid Primary Engraftment with CD33-Negative Hematopoiesis in Patients with High-Risk Acute Myeloid Leukemia (AML) and Avoids Hematopoietic Toxicity during Gemtuzumab Ozogamicin (GO) Maintenance Post-Hematopoietic Cell Transplant (HCT)

Blood2023-11-029 citations

CD33-Deleted Hematopoietic Cells (Trem-Cel) Are Protected from CD33xCD3 Bispecific Antibody Treatment and Produce Significantly Reduced Levels of Inflammatory Cytokines in Preclinical Studies

Blood2023-11-02

Development of a gene edited next-generation hematopoietic cell transplant to enable acute myeloid leukemia treatment by solving off-tumor toxicity

Molecular Therapy — Methods & Clinical Development2023-10-1315 citations

P1396: CD33-DELETED HEMATOPOIETIC STEM AND PROGENITOR CELLS DISPLAY NORMAL ENGRAFTMENT AFTER HEMATOPOIETIC CELL TRANSPLANT (HCT) AND TOLERATE POST-HCT GEMTUZUMAB OZOGAMICIN (GO) WITHOUT CYTOPENIAS

HemaSphere2023-08-013 citations

Trial in Progress: A First-in-Human Phase 1/2 Study of Hematopoietic Stem Cell Transplantation (HCT) with VOR33 (CD33-Deleted Allograft) Followed By Treatment with Gemtuzumab Ozogamicin (GO) in Patients with CD33+ Acute Myeloid Leukemia (AML) Who Are at High-Risk of Post-HCT Relapse

Blood2022-11-154 citations