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Checkpoint Inhibitor
Ipilimumab + DLI for Leukemia
Phase 1
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 92 and week 60
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 92 and week 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 92 and week 60
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 (MTD)
Secondary outcome measures
Incidence and Severity of Acute GVHD Rates
Incidence and Severity of Chronic GVHD Rates
Overall Survival
+2 moreSide effects data
From 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin
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
2014
Completed Phase 3
~2610
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
340,905 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment or still have side effects from treatments done more than 4 weeks ago, except for hydroxyurea.I do not have any serious illnesses that would stop me from following the study's requirements.I am not HIV-positive or not on antiretroviral therapy.I have had a donor lymphocyte infusion in the past.I agree to use birth control during and after the study as required.I haven't taken high doses of steroids for conditions other than GVHD in the last 4 weeks.I am not pregnant.I can take care of myself but might not be able to do heavy physical work.You have had allergic reactions in the past to drugs similar to Ipilimumab or other drugs being used in this study.I haven't taken any systemic treatments for GVHD in the last 4 weeks.My cancer (AML, MDS, or MPN) has returned and shows more than 5% blasts in the marrow.My cancer has spread to areas like the brain, eyes, or testes.My organs are functioning well.I have been treated with specific immune therapies before.I do not have autoimmune diseases like Crohn's, lupus, or rheumatoid arthritis, but Hashimoto's thyroiditis is okay.I do not have active, uncontrolled hepatitis B or C.My condition worsened 2 months after a closely matched stem cell transplant.I am 18 years old or older.I have received an organ transplant from another person.I have had severe graft-versus-host disease or it's currently active and needs treatment.
Research Study Groups:
This trial has the following groups:- Group 1: CD25/Treg-depleted DLI + Ipilimumab
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.
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