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Anti-metabolites

Ipilimumab + Decitabine for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Jacqueline S Garcia

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treatment-naive AML: must be 75 years and older with de novo or secondary AML to be considered eligible

Relapsed MDS: disease recurrence after CR, partial remission (PR) or hematologic improvement with bone marrow blasts >= 5% who relapse after:

Must not have

No concurrent active malignancies are allowed on study for >= 2 years prior to treatment start

For patients that are post-transplant, ineligible patients include those with a history of overall grade III or IV (severe) acute GVHD at any time even if resolved

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 100 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of ipilimumab when given with decitabine to treat patients with myelodysplastic syndrome or acute myeloid leukemia that has returned or does not respond to treatment.

Who is the study for?

This trial is for adults with relapsed or refractory myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Eligible participants may have had certain treatments like chemotherapy, stem cell transplant, and must be in a stable condition. They should not have severe autoimmune diseases, active infections that aren't controlled, other cancers within the last 2 years, or known brain involvement by leukemia.

What is being tested?

The trial tests the combination of Ipilimumab (an immunotherapy drug) and Decitabine (a chemotherapy drug) to see if they're more effective together against MDS/AML that's come back or hasn't responded to treatment. It aims to find the safest dose with the least side effects.

What are the potential side effects?

Possible side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from receiving drugs through a vein, fatigue, digestive issues such as nausea and constipation, blood disorders like anemia or clotting problems, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 75 or older with newly diagnosed or secondary AML and have not received treatment.

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My MDS has returned after some improvement.

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I have had a stem cell transplant from a donor.

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I have MDS that is either untreated or has been treated before.

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My MDS did not improve after treatment with a specific medication.

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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 AML has returned, showing more than 5% blasts in my bone marrow or blasts in my blood.

Exclusion Criteria

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

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I haven't had any other cancers for at least 2 years.

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I have not had severe acute GVHD after a transplant.

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I have leukemia in my brain or spinal cord and am receiving treatment for it.

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I have been treated with specific immune therapies before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 100 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Decitabine

Secondary study objectives

Anti-leukemic activity described in terms of best overall response rate

Anti-leukemic activity described in terms of overall survival

Anti-leukemic activity described in terms of progression free survival

+2 more

Other study objectives

Ability of absolute lymphocyte count to predict response

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%

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

2Treatment groups

Experimental Treatment

Group I: Arm B (decitabine, ipilimumab)Experimental Treatment2 Interventions

PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days. INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (decitabine, ipilimumab)Experimental Treatment2 Interventions

PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days. INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

2004

Completed Phase 3

~1720

Ipilimumab

2015

Completed Phase 3

~3420