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Report for Clinical Trial NCT03737955

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2 Trial of Fractionated Gemtuzumab Ozogamicin to Eradicate Measurable Residual Disease in Acute Myeloid Leukemia Patients (GO for MRD)

This phase II trial studies the how well fractionated gemtuzumab ozogamicin works in treating measurable residual disease in participants with acute myeloid leukemia. Immunotherapy with monoclonal antibodies, such as gemtuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT03737955 Acute Myeloid Leukemia CD33 Positive Minimal Residual Disease
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasm, Residual
HPO:Acute megakaryocytic leukemia Acute myeloid leukemia Leukemia Myeloid leukemia

2 Interventions

Name: Gemtuzumab Ozogamicin

Description: Receive IV
Type: Drug
Group Labels: 1

Treatment (gemtuzumab ozogamicin)

Name: Quality-of-Life Assessment

Description: Ancillary studies
Type: Other
Group Labels: 1

Treatment (gemtuzumab ozogamicin)


Primary Outcomes

Description: Measured by clearance of measurable residual disease (MRD) with bone marrow evaluation after one or two cycles of therapy and compare responses (rate of eradication of MRD) based on CD33 single nucleotide polymorphism rs12459419 genotype.

Measure: Clinical response rate

Time: Up to 70 days

Secondary Outcomes

Description: Measured by grade III/IV non-hematologic toxicities using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.

Measure: Rate of sinusoidal obstructive syndrome (SOS)

Time: Up to 6 months

Description: Measured by those receiving HCT

Measure: Rate of allogeneic hematopoietic cell transplantation (HCT)

Time: Up to 6 Months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 rs12459419

Measured by clearance of measurable residual disease (MRD) with bone marrow evaluation after one or two cycles of therapy and compare responses (rate of eradication of MRD) based on CD33 single nucleotide polymorphism rs12459419 genotype.. Rate of sinusoidal obstructive syndrome (SOS).



HPO Nodes


HPO:
Protein Mutations 0
SNP 0