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Checkpoint Inhibitor

Ipilimumab + DLI for Leukemia

Phase 1
Waitlist Available
Led By John Koreth, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Negative pregnancy test for females of childbearing potential only
ECOG performance status ≤2 (Karnofsky performance status ≥60, see Appendix A)
Must not have
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with agents used in this study. In addition, these participants are at increased risk of lethal infections when treated with marrow- suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 92 and week 60
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a cancer drug to see what the highest safe dose is and what side effects it has in patients with different types of blood cancer.

Who is the study for?
Adults over 18 with certain relapsed myeloid diseases after a matched stem cell transplant can join. They must have adequate organ function, no severe GVHD or recent treatments for it, and agree to use contraception. Excluded are those with autoimmune diseases, uncontrolled illnesses, prior anti-CTLA-4/PD-1 therapy, active infections like HIV/hepatitis B/C, or pregnant/nursing women.
What is being tested?
The trial is testing the highest safe dose of Ipilimumab and CD25hi Treg depleted DLI in patients with AML, MDS, MPN (including CMML), or Myelofibrosis post-transplant. It aims to find out what side effects occur at different doses.
What are the potential side effects?
Ipilimumab may cause immune-related adverse effects such as inflammation of organs (colitis, hepatitis), skin problems (rash), hormone gland issues (thyroiditis), and other reactions that vary from mild to potentially severe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer (AML, MDS, or MPN) has returned and shows more than 5% blasts in the marrow.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious illnesses that would stop me from following the study's requirements.
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I am not HIV-positive or not on antiretroviral therapy.
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I have had a donor lymphocyte infusion in the past.
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I have been treated with specific immune therapies before.
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I do not have active, uncontrolled hepatitis B or C.
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I have received an organ transplant from another person.
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I have had severe graft-versus-host disease or it's currently active and needs treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 92 and week 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 92 and week 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD)
Secondary study objectives
Incidence and Severity of Acute GVHD Rates
Incidence and Severity of Chronic GVHD Rates
Overall Survival
+2 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

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: CD25/Treg-depleted DLI + IpilimumabExperimental Treatment2 Interventions
* Ipilimumab is administered intravenously every 12 weeks * Patients will receive a defined dose of CD25hi Treg depleted DLI intravenously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2015
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,110 Previous Clinical Trials
358,273 Total Patients Enrolled
John Koreth, MDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Maulana Azad Medical College (Medical School)
Brigham & Women'S Hospital (Residency)
1 Previous Clinical Trials
45 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03912064 — Phase 1
Acute Myeloid Leukemia Research Study Groups: CD25/Treg-depleted DLI + Ipilimumab
Acute Myeloid Leukemia Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03912064 — Phase 1
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03912064 — Phase 1
~4 spots leftby Dec 2025
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