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Gemtuzumab + Midostaurin for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Ronan Swords, M.D.
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed AML as confirmed by bone marrow and/or peripheral blood examination as indicated, with: Confirmed CD33 positivity, per institutional standards Presence of FLT3 internal tandem duplication (ITD) or tyrosine kinase domain (TKD) mutation as confirmed by next-generation sequencing (NGS) or other molecular method Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN; local laboratory) Alanine aminotransferase (ALT) < 2.5 x ULN Total bilirubin < 2 x ULN (except for patients with known Gilbert's syndrome) Calculated creatinine clearance (according to the Cockcroft-Gault equation) > 40 mL/min OR serum creatinine < 1.5 x the ULN Female patients of childbearing potential must agree to use adequate contraception (2 forms of contraception or abstinence) from the screening visit until 6 months following the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Male patients of childbearing potential having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use 2 forms of contraception from the screening visit until 3 months following the last dose of study treatment. They must also refrain from sperm donation from the screening visit until 90 days following the last dose of study treatment
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new combination of two drugs, gemtuzumab ozogamicin and midostaurin, to see if it is safe and tolerable in patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia (AML).

Who is the study for?
This trial is for adults with newly diagnosed FLT-3 mutated Acute Myeloid Leukemia (AML) who can sign consent, have an ECOG status of ≤2, and CD33 positive AML. They must not have had previous AML treatments, no active HIV or hepatitis B/C, and agree to contraception use. Those with severe heart issues, uncontrolled infections or certain allergies are excluded.Check my eligibility
What is being tested?
The study tests a combination of gemtuzumab ozogamicin (GO) and midostaurin with standard cytarabine and daunorubicin chemotherapy in patients with new FLT-3 mutated AML. It aims to find out if this novel approach is safe and how well patients tolerate it.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as fever or chills during infusion, bleeding problems due to low blood cell counts, liver function changes, nausea or vomiting from chemotherapy drugs used in the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum-tolerated dose (MTD) of combining gemtuzumab ozogamicin with cytarabine, daunorubicin, and midostaurin
Secondary outcome measures
Duration of response
Event free survival
Incidence of 30-day treatment-related mortality
+5 more
Other outcome measures
CD33 expression
CD33 single nucleotide polymorphism (SNP)

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575
5%
Hypoxia
5%
Febrile neutropenia
5%
Acute kidney injury
4%
Blood bilirubin increased
4%
Diarrhea
4%
Creatinine increased
4%
Sepsis
3%
Hypotension
3%
Left ventricular systolic dysfunction
3%
Bronchopulmonary hemorrhage
3%
Chronic kidney disease
3%
Thromboembolic event
3%
Lung infection
1%
Atrial fibrillation
1%
Atrial flutter
1%
Hemolysis
1%
Hemolytic uremic syndrome
1%
Ejection fraction decreased
1%
Encephalitis infection
1%
Gastric hemorrhage
1%
Gastritis
1%
Heart failure
1%
Mucositis oral
1%
Multi-organ failure
1%
Myalgia
1%
Pleural effusion
1%
Respiratory failure
1%
Small intestine infection
1%
Syncope
1%
Treatment related secondary malignancy
1%
Typhlitis
1%
Fever
1%
Paroxysmal atrial tachycardia
1%
Ascites
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Fludarabine, Transplant, Immunosuppression)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (gemtuzumab ozogamicin, cytarabine, daunorubicin)Experimental Treatment5 Interventions
INDUCTION THERAPY: Cytarabine intravenously (IV) on days 1-7, daunorubicin IV on days 1-3 and midostaurin 50 mg orally (PO) twice daily (BID) on days 8-21. Gemtuzumab ozogamicin IV may be given either on days 1, or days 1 and 4 or days 1, 4 and 7. RE-INDUCTION THERAPY: Between days 14 and 21 of Induction Therapy, patients may receive a single 28-day cycle of cytarabine and daunorubicin with or without midostaurin per the treating physician. Patients may also undergo allogeneic stem cell transplantation (SCT) or receive consolidation therapy. CONSOLIDATION THERAPY: PATIENTS < 60 YEARS: high dose cytarabine (HiDAC) IV on days 1, 3, and 5 and gemtuzumab ozogamicin IV on day 1 of cycle 1 and midostaurin 50 mg PO BID on days 8-21. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. PATIENTS >= 60 YEARS: Same as above except cytarabine (MiDAC) IV on days 1, 3, and 5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~440
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5070
Midostaurin
2018
Completed Phase 3
~1640
Cytarabine
2016
Completed Phase 3
~3310
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,708 Total Patients Enrolled
Uma BorateLead Sponsor
5 Previous Clinical Trials
227 Total Patients Enrolled
Ronan Swords, M.D.Principal InvestigatorOHSU Knight Cancer Institute

Media Library

Acute Myeloid Leukemia Research Study Groups: Treatment (gemtuzumab ozogamicin, cytarabine, daunorubicin)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has Allogeneic Hematopoietic Stem Cell Transplantation been utilized to treat various afflictions?

"Allogenic Hematopoietic Stem Cell Transplantation is a common therapy for leukemia, myelocytic acute, and other diseases such as blast phase chronic myelocytic leukemia and lymphoma. It may also be utilized to prevent meningeal leukaemia."

Answered by AI

Is the utilization of Allogeneic Hematopoietic Stem Cell Transplantation permitted by the FDA?

"The safety of Allogeneic Hematopoietic Stem Cell Transplantation has been assigned a score of 1 as this trial is still in its initial phase and thus only preliminary evidence exists bearing on efficacy and safety."

Answered by AI

Have there been any prior experiments that have utilized Allogeneic Hematopoietic Stem Cell Transplantation?

"Currently, there are 278 trials pertaining to Allogeneic Hematopoietic Stem Cell Transplantation underway. Out of those studies, 67 have progressed to their third phase and the bulk of these investigations are centered in Providence, Rhode island. Additionally, a large number of medical centres across 12948 locations worldwide offer this therapy as part of clinical experiments."

Answered by AI

How many individuals have signed up to participate in this research endeavor?

"Affirmative. Clinicaltrials.gov attests to this medical study's ongoing recruitment process, which began on March 13th 2019 and was recently amended on May 17th 2022. The trial requires 24 volunteers from 3 different sites for completion."

Answered by AI

Does this experiment currently accommodate new participants?

"According to information on clinicaltrials.gov, this experiment is presently recruiting volunteers; it was initially posted on March 13th 2019 and its details were last edited May 17th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia
Uma Borate 2019. "Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03900949.
~2 spots leftby Jan 2025
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