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Tagraxofusp for Leukemia Maintenance Post-Transplant
Phase 1
Recruiting
Led By Karen Ballen
Research Sponsored by Karen Ballen, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has adequate baseline organ function including cardiac, renal, and hepatic function within 28 days of start of therapy: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition scan (MUGA) or 2-dimensional (2-D) echocardiogram (ECHO) and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG), Serum Creatinine ≤ 1.5 mg/dL, Bilirubin ≤1.5 mg/dL, Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN), Absolute neutrophil count (ANC) ≥0.5 × 10⁹/L, Platelets ≥ 80,000/mm^3, Serum albumin ≥3.2 (note that albumin infusions are not permitted in order to enable eligibility)
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
Must not have
Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction or stroke within 6 months of study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication)
Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will be followed through 2 years after date of hct
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the use of tagraxofusp to prevent relapse in patients with leukemia who have undergone allogeneic stem cell transplant.
Who is the study for?
Adults aged 18-75 with CD123+ myelofibrosis, chronic myelomonocytic leukemia, or acute myeloid leukemia who've had a stem cell transplant within the last 60-120 days. They should be in remission post-transplant and have good organ function. Participants must agree to use contraception and adhere to lifestyle guidelines.
What is being tested?
The trial is testing Tagraxofusp as a maintenance therapy after allogeneic stem cell transplant for patients with certain blood cancers. It aims to prevent cancer relapse over up to nine treatment cycles, including bone marrow biopsies after cycle four and around one year post-transplant.
What are the potential side effects?
Specific side effects of Tagraxofusp are not listed but may include reactions at the infusion site, potential liver issues (as indicated by eligibility criteria on bilirubin levels), fatigue, immune system impacts (based on neutrophil count requirements), and other common drug-related risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have serious heart problems like uncontrolled heart failure or recent heart attack.
Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
My cancer has spread to or is suspected to be in my brain or spinal cord.
Select...
I have moderate to severe swelling in my feet.
Select...
I am currently experiencing a moderate to severe reaction from a transplant.
Select...
I have never been treated with tagraxofusp and am not allergic to it.
Select...
I need extra oxygen.
Select...
I have HIV, Hepatitis B, or Hepatitis C.
Select...
I am taking more than 10 mg of prednisone daily for graft-versus-host disease.
Select...
I am currently being treated for a fungal infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ participants will be followed through 2 years after date of hct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will be followed through 2 years after date of hct
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose limiting toxicities
Incidence and severity of grade ≥ 3 adverse events
Percent of planned tagraxofusp dose received
Secondary study objectives
Frequency and severity of acute GVHD grades II-IV and chronic GVHD
Time from HCT to relapse and death or last contact.
Side effects data
From 2020 Phase 1 & 2 trial • 138 Patients • NCT02113982100%
Nausea
100%
Alanine aminotransferase increased
100%
Hyperglycaemia
100%
Dizziness
100%
Decreased appetite
100%
Fatigue
67%
Dyspnoea exertional
67%
Asthenia
67%
Cough
67%
Night sweats
67%
Flushing
67%
Lymphopenia
67%
Back pain
67%
Dyspnoea
67%
Oedema peripheral
67%
Atrial fibrillation
67%
Aspartate aminotransferase increased
67%
Pyrexia
67%
Palpitations
67%
Vomiting
67%
Hypoalbuminaemia
33%
Petechiae
33%
Chest discomfort
33%
Chills
33%
Bone pain
33%
Upper gastrointestinal haemorrhage
33%
Cardiac failure congestive
33%
Febrile neutropenia
33%
Facial pain
33%
Lymphocytosis
33%
Myalgia
33%
Anaemia
33%
Neuropathy peripheral
33%
Face oedema
33%
Lip pain
33%
Hyperphosphataemia
33%
Headache
33%
Contusion
33%
Rash
33%
Hypocalcaemia
33%
Erythema
33%
Hyperhidrosis
33%
Dysphonia
33%
Hyperkalaemia
33%
Arthralgia
33%
Syncope
33%
Hypotension
33%
Pain in extremity
33%
Gastritis haemorrhagic
33%
Dysgeusia
33%
Dry skin
33%
Hypokalaemia
33%
Epistaxis
33%
Urticaria
33%
Retching
33%
Tongue blistering
33%
Lethargy
33%
Hyperaesthesia
33%
Infusion related reaction
33%
Thrombocytopenia
33%
Abdominal pain
33%
Abdominal pain upper
33%
Diarrhoea
33%
Gingival bleeding
33%
Hyponatraemia
33%
Incision site cellulitis
33%
Blood alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stage 1 - AML Indication: 7 µg/kg/Day Dosage
R/R - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
1L - Stage 3 - BPDCN Indication: 12 µg/kg/Day Dosage
Stage 1 - AML Indication: 9 µg/kg/Day Dosage
Stage 2 - AML Indication: 12 µg/kg/Day Dosage
1L - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
Stage 1 - AML Indication: 16 µg/kg/Day Dosage
1L - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
1L - Stage 1 - BPDCN Indication: 7 µg/kg/Day Dosage
Stage 2 - AML Indication: 16 µg/kg/Day Dosage
R/R - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
R/R - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
1L - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
Stage 1 - AML Indication: 12 µg/kg/Day Dosage
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tagraxofusp (escalating doses)Experimental Treatment1 Intervention
IV tagraxofusp on days 1-3 of cycles 1-4 and days 1-2 of additional cycles for up to 9 cycles (some participants could receive more if considered in their best interest)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tagraxofusp
2014
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Karen Ballen, MDLead Sponsor
Karen BallenPrincipal InvestigatorUVA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious heart problems like uncontrolled heart failure or recent heart attack.I have a history of cancer, but it's not one that would affect this study's results.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My cancer has spread to or is suspected to be in my brain or spinal cord.I can take care of myself and am up and about more than half of my waking hours.I haven't had any cancer treatment, including radiation, in the last 14 days.I do not have severe lung problems that would risk my health in the study.I have moderate to severe swelling in my feet.I am currently experiencing a moderate to severe reaction from a transplant.I have never been treated with tagraxofusp and am not allergic to it.I need extra oxygen.I am between 18 and 75 years old.I have HIV, Hepatitis B, or Hepatitis C.I am taking more than 10 mg of prednisone daily for graft-versus-host disease.I am currently being treated for a fungal infection.
Research Study Groups:
This trial has the following groups:- Group 1: Tagraxofusp (escalating doses)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.