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Monoclonal Antibodies

Gemtuzumab Ozogamicin 2 mg/m^2 for Adult Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By Sameem Abedin, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This study is evaluating whether a combination of two drugs may help treat acute myeloid leukemia.

Eligible Conditions
  • Adult Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
The number of subjects experiencing a dose-limiting toxicity.
Secondary outcome measures
Number of subjects progression free at 6 months.
Number of subjects surviving at six months.
The number of subjects with a complete response.
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Pracinostat with Gemtuzumab Ozogamicin MaintenanceExperimental Treatment2 Interventions
Response will be assessed through bone marrow biopsy on Day 28. Patients achieving at least a partial remission marrow will be offered up to 5 cycles of maintenance therapy. Maintenance should begin no later than 42 days after initial induction. Gemtuzumab Ozogamicin Maintenance: 2 mg/m^2 intravenous administration on day 1, in a 28-day cycle. Pracinostat Maintenance: (In addition to GO, only if induction dose escalation occurs) 45 mg orally 3 days a week with 48 hours between dosing, for three consecutive weeks, followed by 1 week of rest, in a 28-day cycle.
Group II: Pracinostat 60 mg with Gemtuzumab OzogamicinExperimental Treatment2 Interventions
Gemtuzumab Ozogamicin Induction: GO 3 mg/m^2 on Day 1, 4, and 7 Pracinostat: 60 mg administered orally 3 days a week with 48 hours between dosing for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles. We will utilize a 3+3 design to determine the safe dose of pracinostat in combination with fixed dose GO. If there are no DLTs in the first three patients, the dose of pracinostat will be escalated to 60mg. Escalation to the next dose level will be done only after the third patient on the previous dose level has been observed for 28 days, and no DLTs were noticed. If there is 1 DLT, an additional 3 patients will be tested at same dose level. If there are ≥ 2 DLTs in 3 or 6 patients, the study will be placed on hold. If there is < 2 DLTs in the first 3 or 6 patients, the dose of pracinostat will be escalated to 60mg. If there are no DLTs in the first 3 patients at 60 mg, an additional 3 patients will be enrolled to ensure 6 patients are treated at the MTD.
Group III: Pracinostat 45 mg with Gemtuzumab OzogamicinExperimental Treatment2 Interventions
Gemtuzumab Ozogamicin Induction: GO 3 mg/m^2 on Day 1, 4, and 7 Pracinostat Induction: 45 mg administered orally 3 days a week with 48 hours between dosing for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles. We will utilize a 3+3 design to determine the safe dose of pracinostat in combination with fixed dose GO. If there are no DLTs in the first three patients, the dose of pracinostat will be escalated to 60mg. Escalation to the next dose level will be done only after the third patient on the previous dose level has been observed for 28 days, and no DLTs were noticed. If there is 1 DLT, an additional 3 patients will be tested at same dose level. If there are ≥ 2 DLTs in 3 or 6 patients, the study will be placed on hold. If there is < 2 DLTs in the first 3 or 6 patients, the dose of pracinostat will be escalated to 60mg. If there are no DLTs in the first 3 patients at 60 mg, an additional 3 patients will be enrolled to ensure 6 patients are treated at the MTD.
Group IV: Gemtuzumab Ozogamicin Monotherapy MaintenanceExperimental Treatment1 Intervention
Response will be assessed through bone marrow biopsy on Day 28. Patients achieving at least a partial remission marrow will be offered up to 5 cycles of maintenance therapy. Maintenance should begin no later than 42 days after initial induction. **Gemtuzumab Ozogamicin Maintenance: 2 mg/m^2 intravenous administration on day 1, in a 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pracinostat - 45 mg
2019
Completed Phase 1
~20
Pracinostat - 60 mg
2019
Completed Phase 1
~20
Gemtuzumab Ozogamicin 2 mg/m^2
2019
Completed Phase 1
~20
Gemtuzumab Ozogamicin 3 mg/m^2
2019
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,569 Total Patients Enrolled
Sameem Abedin, MDPrincipal InvestigatorMedical College of Wisconsin
4 Previous Clinical Trials
10,098 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Sameem M. Abedin, MD 2019. "Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03848754.
~2 spots leftby Apr 2025
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