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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:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 100 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decitabine
Secondary outcome measures
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
+3 moreOther outcome measures
Ability of absolute lymphocyte count to predict response
Side 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
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
~1680
Ipilimumab
2014
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,105 Total Patients Enrolled
Jacqueline S GarciaPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 75 or older with newly diagnosed or secondary AML and have not received treatment.My MDS has returned after some improvement.I haven't had any other cancers for at least 2 years.I received donor lymphocyte infusion within the last 8 weeks after a transplant.I haven't taken strong immune system medications for more than 2 weeks, or have been on a low dose of steroids for over a week.After my bone marrow transplant, at least 20% of my T cells come from the donor.My high bilirubin levels are due to Gilbert's disease or related to my condition, but not above 3 times the normal limit.You cannot participate if you are currently taking any other experimental medications.I have had a stem cell transplant from a donor.I have MDS that is either untreated or has been treated before.I have no restrictions on previous treatments.I have not worsened on HMA therapy for my blood cancer in the last 12 weeks.I have not had severe acute GVHD after a transplant.I have leukemia with no current CNS involvement or I've completed treatment for it.I have AML or MDS that meets specific criteria.I do not have any serious illnesses or conditions that my doctor thinks could make this study unsafe for me.My MDS did not improve after treatment with a specific medication.I have HIV with a CD4 count over 250, no detectable virus, no opportunistic infections, and am on stable HAART.I have leukemia in my brain or spinal cord and am receiving treatment for it.I am not pregnant, will test to confirm, and will use birth control during the study.I haven't had chemotherapy or radiotherapy in the last 2 weeks and have recovered from any side effects.I had brain involvement from cancer but it's fully treated or I need preventive brain chemotherapy.I have AML and have had 2 or fewer prior attempts to treat it, or at least two cycles of a specific drug therapy.I am currently on hormonal therapy.I can take care of myself but might not be able to do heavy physical work.I am taking hydroxyurea for high white blood cell count, which is now below 25 x 10^9/L.I had a stem cell transplant from a donor and it's been over 3 months.I've completed one cycle of chemotherapy or two cycles of therapy with hypomethylating agents.My AML has returned, showing more than 5% blasts in my bone marrow or blasts in my blood.I relapsed after a transplant but was treated with HMA before the transplant.I have completed four cycles of treatment with a hypomethylating agent.I have been treated with specific immune therapies before.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (decitabine, ipilimumab)
- Group 2: Arm A (decitabine, 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elucidate what other investigations have been done using Ipilimumab?
"The first clinical trial of ipilimumab was conducted by Central Illinois Hematology Oncology Center back in 2004, resulting in 303 completed trials. Currently, 419 medical studies are actively enrolling participants, with a large portion taking place at the research centre located in Charlottesville, Virginia."
Answered by AI
How many participants can the trial accommodate at its maximum capacity?
"Sadly, this research trial is no longer accepting new participants. It was originally posted on April 14th 2017 and updated lastly on July 2nd 2022; however, there are currently 4290 medical trials that are actively taking in leukemia patients as well as 419 studies recruiting volunteers to join Ipilimumab testing procedures."
Answered by AI
How is Ipilimumab employed to assist patients?
"Patients with intermediate-2 IPSS risk, refractory anemias, and metastatic melanoma can be treated using ipilimumab."
Answered by AI
Does the use of Ipilimumab carry any potential risk for those taking it?
"While there is only a limited amount of information available regarding the safety and efficacy, Ipilimumab received an overall score of 1 for its risk assessment."
Answered by AI
Does the research team continue to accept participants for this trial?
"Unfortunately, this trial is no longer seeking new patients. Initially posted on April 14th 2017 and last updated July 2nd 2022, alternative trials can be found with 4290 admitting participants for leukemia myeloid acute and 419 studies including Ipilimumab."
Answered by AI
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