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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
The effects of CD25/Treg-depleted DLI and Ipilimumab on the developing human fetus are unknown. For this reason and because immunomodulatory agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study or within 23 weeks after the last dose of study drug, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for at least 31 weeks after completion of Ipilimumab administration.
No systemic corticosteroid therapy for GVHD (≤5 mg of prednisone or equivalent doses of other systemic steroids for non-GVHD, non-autoimmune indications for at least 4 weeks prior to cell infusion)
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 below
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I agree to use birth control during and after the study as required.
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I haven't taken high doses of steroids for conditions other than GVHD in the last 4 weeks.
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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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I haven't taken any systemic treatments for GVHD in the last 4 weeks.
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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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My organs are functioning well.
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My condition worsened 2 months after a closely matched stem cell transplant.
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I am 18 years old or older.

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

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 more

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
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 abscess
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
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
~2670

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,077 Previous Clinical Trials
340,718 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for enrolment in this experiment?

"This clinical trial, which was initiated on July 10th 2019 is currently seeking participants. The most recent update to the study's information occured on June 10th 2022."

Answered by AI

How many participants have enrolled in this experimental investigation?

"Affirmative. According to clinicaltrials.gov, this experimental treatment is still enrolling patients since its initial post on July 10th 2019 and subsequent update from June 10th 2022. Only 25 individuals are required for the trial which will be hosted at two different sites."

Answered by AI

Are there any precursory tests that have been conducted using Ipilimumab?

"Currently, there are 318 clinical trials being conducted on Ipilimumab around the world. Of those active studies, 38 have reached Phase 3 and 20362 locations across America are running these investigations with a particular focus in Pittsburgh, Pennsylvania."

Answered by AI

Has the FDA sanctioned Ipilimumab for therapeutic use?

"Given the initial stages of this trial, there is limited evidence to support both safety and efficacy. Therefore, our team at Power awarded Ipilimumab a score of 1 on their rating scale."

Answered by AI

In what clinical contexts is Ipilimumab typically employed?

"Ipilimumab is frequently administered to treat cutaneous melanoma and, in some cases, can be used to address conditions like complete resection, metastatic melanoma, or liver carcinoma."

Answered by AI
~0 spots leftby May 2024