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Monoclonal Antibodies

Talazoparib + Gemtuzumab for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By Eunice S Wang
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance (Cockcroft and Gault ) > 30 mL/min (performed on plasma unless otherwise indicated)
Peripheral white blood cell (WBC) counts <25,000/mcL. Patients are allowed to receive hydroxyurea and/or leukapheresis to control and maintain WBC count prior to enrollment and can continue on hydroxyurea through Cycle 1 Day 28 or until first disease assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post treatment
Awards & highlights

Study Summary

This trial is testing talazoparib + gemtuzumab ozogamicin to treat patients with relapsed/refractory AML that is CD33+. Talazoparib may work by blocking some enzymes needed for cell growth. Gemtuzumab ozogamicin is an antibody that targets AML cells expressing CD33. Adding talazoparib to gemtuzumab ozogamicin therapy may lead to increased effectiveness in treatment.

Who is the study for?
This trial is for adults with CD33 positive acute myeloid leukemia that has returned or isn't responding to treatment. They must have normal organ function, no severe heart issues, and a performance status indicating they can carry out daily activities without significant limitations. Participants should not be pregnant, breastfeeding, or have other serious medical conditions.Check my eligibility
What is being tested?
The trial is testing the combination of talazoparib and gemtuzumab ozogamicin to determine the best dose and side effects in treating relapsed or refractory acute myeloid leukemia. Talazoparib blocks enzymes needed for cancer cell growth while gemtuzumab ozogamicin targets leukemia cells.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to proteins from the drugs, blood disorders due to chemotherapy components, liver enzyme changes, fatigue from energy depletion in cells, and possible heart function alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by creatinine levels, is within the normal range.
Select...
My white blood cell count is below 25,000/mcL.
Select...
My AML returned after it was previously in remission following chemotherapy.
Select...
I am fully active or can carry out light work.
Select...
My condition has returned or didn't respond to treatment.
Select...
My AML hasn't responded to at least 1 cycle of initial chemotherapy.
Select...
I had a bone marrow transplant over a month ago, am not on strong immunosuppressants, and don't have GVHD.
Select...
I have AML with more than 5% myeloblasts and CD33+.
Select...
My heart pumps well, with an ejection fraction of 40% or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post treatment 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
Overall response rate (ORR)
Secondary outcome measures
Best response rate
Complete remission rate
Duration of remission
+5 more

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777
89%
Anemia
78%
Alkaline phosphatase increased
78%
Nausea
78%
White blood cell decreased
67%
Fatigue
67%
Lymphocyte count decreased
56%
Aspartate aminotransferase increased
56%
Hypermagnesemia
56%
Headache
56%
Neutrophil count decreased
56%
Platelet count decreased
56%
Pain in extremity
44%
Constipation
44%
Hypoalbuminemia
44%
Non-cardiac chest pain
44%
Hyponatremia
33%
Creatinine increased
33%
Hypocalcemia
33%
Anorexia
33%
Back pain
33%
Diarrhea
33%
Alanine aminotransferase increased
33%
Alopecia
33%
Blood bilirubin increased
33%
Dizziness
33%
Fever
33%
Hyperglycemia
33%
Pain
33%
Proteinuria
33%
Sinus tachycardia
33%
Vomiting
22%
Cough
22%
Hypokalemia
22%
Abdominal pain
22%
Dyspnea
22%
Hypercalcemia
22%
Hypernatremia
22%
Hypophosphatemia
22%
Hypotension
22%
Hypoxia
22%
Nasal congestion
22%
Neck pain
11%
Tumor pain
11%
Allergic reaction
11%
Weight loss
11%
Febrile neutropenia
11%
Periorbital infection
11%
Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION
11%
Edema limbs
11%
Irregular menstruation
11%
Bone pain
11%
Dysgeusia
11%
Hemoglobin increased
11%
Musculoskeletal and connective tissue disorder - Other, LARGE OCCIPITAL SKULL DEFECT
11%
Skin and subcutaneous tissue disorders - Other, ERYTHEMA
11%
Urinary urgency
11%
Renal and urinary disorders - Other, BLADDER PAIN
11%
Anxiety
11%
Avascular necrosis
11%
Depression
11%
Hypomagnesemia
11%
Respiratory, thoracic and mediastinal disorders - Other, OBSTRUCTIVE SLEEP APNEA
11%
Edema face
11%
Hematuria
11%
Lymphocyte count increased
11%
Activated partial thromboplastin time prolonged
11%
Cardiac disorders - Other, NON RESTRICTIVE CARDIOMYOPATHY
11%
Cystitis noninfective
11%
Epistaxis
11%
Gait disturbance
11%
Gastroesophageal reflux disease
11%
Hypertension
11%
Infections and infestations - Other, SHINGLES ZOSTER
11%
Insomnia
11%
Investigations - Other, BICARBONATE DECREASED
11%
Investigations - Other, BICARBONATE INCREASED
11%
Investigations - Other, BICARBONATE LOW
11%
Metabolism and nutrition disorders - Other, CHLORIDE LEVEL
11%
Mucosal infection
11%
Muscle weakness right-sided
11%
Pericardial effusion
11%
Pleural effusion
11%
Rash acneiform
11%
Respiratory, thoracic and mediastinal disorders - Other, ASTHMA
11%
Skin hyperpigmentation
11%
Skin ulceration
11%
Stomach pain
11%
Thromboembolic event
11%
Tinnitus
11%
Urinary retention
11%
Obesity
100%
80%
60%
40%
20%
0%
Study treatment Arm
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day
600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (talazoparib, gemtuzumab ozogamicin)Experimental Treatment5 Interventions
Patients receive talazoparib PO daily on days 1-21 and gemtuzumab ozogamicin IV over 2 hours on days 1, 4, and 7 or day 1 for patients who CR/CRi after cycles 1 or 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~440
Talazoparib Tosylate
2015
Completed Phase 2
~30
Talazoparib
2021
Completed Phase 2
~2740

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
397 Previous Clinical Trials
30,494 Total Patients Enrolled
PfizerIndustry Sponsor
4,556 Previous Clinical Trials
10,907,663 Total Patients Enrolled
Eunice S WangPrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials

Media Library

Gemtuzumab Ozogamicin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04207190 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Treatment (talazoparib, gemtuzumab ozogamicin)
Acute Myeloid Leukemia Clinical Trial 2023: Gemtuzumab Ozogamicin Highlights & Side Effects. Trial Name: NCT04207190 — Phase 1
Gemtuzumab Ozogamicin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04207190 — Phase 1

Frequently Asked Questions

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

Could you explain what Talazoparib is most often prescribed for?

"Patients with leukemia, myelocytic, acute, newly diagnosed, and brca1 gene can all be treated using Talazoparib."

Answered by AI

Does Talazoparib have a history of being studied in clinical trials?

"86 clinical trials involving Talazoparib are underway, with 6 of them in Phase 3. The most studies for Talazoparib are based Boston, Massachusetts, but there are 2893 total locations running trials for this medication."

Answered by AI

What are the primary objectives of this experiment?

"The goal of this 28-day clinical trial is to assess the overall response rate (ORR). Additionally, the study will evaluate best response rate (defined as CRi and partial remission [PR]), overall survival (OS; estimated using standard Kaplan-Meier methods), and incidence of adverse events (AEs; summarized by dose level and grade using frequencies and relative frequencies)."

Answered by AI

How many people are eligible to enroll in this test phase of the research?

"That is correct, the clinical trial is recruiting patients as indicated by the information on clinicaltrials.gov. The study was first posted on 10/23/2020 and has been updated as recently as 6/15/2022. They are enrolling a total of 20 participants at 2 sites."

Answered by AI

Are there any openings for patients who want to participate in this clinical trial?

"That is correct, the clinical trial listed on clinicaltrials.gov is currently looking for 20 volunteers at 2 sites. The study was first posted on 10/23/2020 and was most recently edited on 6/15/2022."

Answered by AI
~2 spots leftby Oct 2024