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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 below

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I can take care of myself and am up and about more than half of my waking hours.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart problems like uncontrolled heart failure or recent heart attack.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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My cancer has spread to or is suspected to be in my brain or spinal cord.

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I have moderate to severe swelling in my feet.

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I am currently experiencing a moderate to severe reaction from a transplant.

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I have never been treated with tagraxofusp and am not allergic to it.

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I need extra oxygen.

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I have HIV, Hepatitis B, or Hepatitis C.

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I am taking more than 10 mg of prednisone daily for graft-versus-host disease.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed through 2 years after date of hct for reporting.

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 • NCT02113982

80%

Hypoalbuminaemia

60%

Pyrexia

60%

Oedema peripheral

50%

Nausea

50%

Fatigue

50%

Aspartate aminotransferase increased

50%

Alanine aminotransferase increased

50%

Thrombocytopenia

50%

Chills

40%

Neutropenia

40%

Hypotension

30%

Blood creatinine increased

30%

Back pain

30%

Capillary leak syndrome

30%

Hyperglycaemia

30%

Dyspnoea

30%

Hypertension

20%

Hyperuricaemia

20%

Pneumonia

20%

Mental status changes

20%

Hypomagnesaemia

20%

Hypocalcaemia

20%

Anaemia

20%

Blood alkaline phosphatase increased

20%

Decreased appetite

20%

Abdominal pain

20%

Urinary tract infection

20%

Hypokalaemia

20%

Haematuria

20%

Cough

20%

Lymphocytosis

20%

Vomiting

20%

Febrile neutropenia

20%

Pruritus

20%

Lymphopenia

20%

Tumour lysis syndrome

20%

Activated partial thromboplastin time prolonged

20%

Hypophosphataemia

10%

Non Cardiac Chest Pain

10%

Insomnia

10%

Escherichia Sepsis

10%

Diarrhoea

10%

Epistaxis

10%

Musculoskeletal pain

10%

Headache

10%

Anxiety

10%

Infusion related reaction

10%

Eye pain

10%

Abdominal pain upper

10%

Hyperbilirubinaemia

10%

Blood fibrinogen decreased

10%

Stomatitis

10%

Hypoxia

10%

Constipation

10%

Blood lactate dehydrogenase increased

10%

Bone pain

10%

Acute kidney injury

10%

Rash

10%

Deep vein thrombosis

10%

Blood creatine phosphokinase increased

10%

Metabolic Encephalopathy

10%

Asthenia

10%

Leukopenia

10%

Dry skin

10%

Hypermagnesaemia

10%

Proteinuria

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pain in extremity

10%

Musculoskeletal chest pain

10%

Leukocytosis

10%

International normalised ratio increased

10%

Weight increased

10%

Hypernatraemia

10%

Hyponatraemia

10%

Neuropathy peripheral

10%

Transaminases increased

10%

Aspartate Aminotransferase Increased

10%

Dizziness

100%

80%

60%

40%

20%

Study treatment Arm

R/R - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage

1L - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage

1L - Stage 1 - BPDCN 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

1L - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage

Stage 1 - AML Indication: 12 µg/kg/Day Dosage

Stage 1 - AML Indication: 7 µg/kg/Day Dosage

Stage 1 - AML Indication: 16 µg/kg/Day Dosage

1L - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage

Stage 2 - AML Indication: 12 µg/kg/Day Dosage

Stage 2 - AML Indication: 16 µg/kg/Day Dosage

R/R - Stage 1 - BPDCN 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

0 / 13Eligibility criteria met