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Anti-tumor antibiotic, Anti-metabolites
Pomalidomide + Chemotherapy for Acute Myeloid Leukemia
Phase 2
Recruiting
Led By Joshua F Zeidner
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
+8
Must meet criteria for t-AML or AML with MRC as defined by the 5th Edition of the World Health Organization (WHO) Classification of Myeloid Neoplasms or the International Consensus Classification (ICC) of Myeloid Neoplasms. Patients must meet one of the following criteria: Therapy-related AML (AML derived from prior chemotherapy or radiation therapy) AML originating from prior hematologic malignancy (MDS, CMML, or MPN)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing the addition of pomalidomide to usual chemotherapy in treating patients with newly diagnosed acute leukemia with myelodysplastic syndrome-related changes.
Who is the study for?
Adults aged 18-75 with newly diagnosed acute myeloid leukemia (AML) and specific genetic mutations or changes related to myelodysplastic syndrome, who have good organ function and performance status. They must not have had previous AML treatment except hydroxyurea or leukapheresis, no Wilson's Disease, uncontrolled illnesses, prior allogeneic stem cell transplant, or certain cumulative doses of daunorubicin. Women of childbearing potential must test negative for pregnancy and use two forms of birth control.Check my eligibility
What is being tested?
The trial is testing the addition of Pomalidomide—an immunomodulatory drug—to standard chemotherapy (Daunorubicin and Cytarabine Liposome) in patients with AML that has characteristics similar to myelodysplastic syndrome. The study aims to see if this combination improves outcomes compared to the usual treatment alone.See study design
What are the potential side effects?
Pomalidomide may cause blood vessel growth inhibition, immune system stimulation leading to cancer cell death but also risks like blood clots and fetal harm if taken during pregnancy. Standard chemo can cause side effects such as hair loss, nausea, vomiting, fatigue, infection risk increase due to low blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia is classified as therapy-related or stems from a previous blood disorder.
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My leukemia diagnosis was confirmed with a specific test showing more than 20% immature blood cells.
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My cancer has a specific genetic change known as del(11q).
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My cancer has a specific genetic feature (-13/del(13q)).
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My cancer has a specific genetic change in chromosome 12.
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My cancer has a specific genetic change known as idicX(q13).
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My hepatitis B virus load is undetectable with treatment.
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My cancer has a STAG2 mutation.
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My leukemia is classified as t-AML or AML with MRC by WHO or ICC standards.
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My AML was caused by previous cancer treatments.
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My AML is linked to specific genetic changes.
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My AML has specific mutations and I've only had hydroxyurea or leukapheresis.
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My kidneys are functioning well enough to clear waste.
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My AML developed from a previous blood disorder.
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My cancer has a specific genetic abnormality.
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My AML is linked to certain genetic changes.
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My cancer has a specific genetic change (-17/add(17p) or del(17p)).
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My cancer has a specific genetic change known as del(20q).
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I am between 18 and 75 years old and ready for intensive chemotherapy.
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My cancer has a complex genetic profile with multiple chromosomal abnormalities.
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My AML has mutations related to myelodysplasia.
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I have AML and have only been treated with hydroxyurea or leukapheresis.
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My condition involves a -7/del(7q) chromosome abnormality.
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My cancer has a specific genetic change involving chromosome 5.
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I can take care of myself but may not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of complete response (CR)/complete response with incomplete hematologic recovery (CRi)
Secondary outcome measures
CR with full hematologic recovery (absolute neutrophil count > 1 x 10^9/L and platelets > 100 x 10^9/L)
Complete response (CR) without minimal residual disease (MRD)
Disease-free survival
+4 moreSide effects data
From 2015 Phase 2 trial • 36 Patients • NCT0201111372%
NEUTROPENIA
47%
ANAEMIA
44%
THROMBOCYTOPENIA
25%
NASOPHARYNGITIS
25%
PYREXIA
25%
CONSTIPATION
22%
LYMPHOPENIA
19%
DIARRHOEA
19%
OEDEMA PERIPHERAL
19%
NAUSEA
19%
RASH
17%
LEUKOPENIA
17%
INSOMNIA
17%
MALAISE
14%
PNEUMONIA
14%
DYSGEUSIA
11%
EPISTAXIS
11%
FATIGUE
11%
DECREASED APPETITE
11%
HYPERURICAEMIA
11%
HYPOALBUMINAEMIA
11%
UPPER RESPIRATORY TRACT INFECTION
11%
HYPOKALAEMIA
8%
RASH MACULO-PAPULAR
8%
Pharyngitis
8%
HYPERGLYCAEMIA
8%
HYPOPHOSPHATAEMIA
8%
HYPOXIA
8%
ANXIETY
8%
MYALGIA
8%
HEPATIC FUNCTION ABNORMAL
8%
HERPES ZOSTER
6%
CANCER PAIN
6%
WEIGHT INCREASED
6%
GASTROENTERITIS
6%
HEADACHE
6%
DECUBITUS ULCER
6%
NEUROPATHY PERIPHERAL
6%
CYSTITIS
6%
DIABETES MELLITUS
6%
PERIPHERAL SENSORY NEUROPATHY
6%
INCREASED APPETITE
6%
RESTLESSNESS
6%
HYPOTENSION
6%
HYPOGAMMAGLOBULINAEMIA
6%
ABDOMINAL PAIN UPPER
6%
HAEMORRHOIDS
6%
ASTHMA
6%
VOMITING
6%
BRONCHITIS
6%
HYPERCALCAEMIA
6%
HYPOCALCAEMIA
6%
HYPONATRAEMIA
6%
HYPERSOMNIA
6%
DYSPHONIA
6%
PLEURAL EFFUSION
6%
HICCUPS
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
MUSCLE SPASMS
6%
WEIGHT DECREASED
6%
TREMOR
6%
HYPOTHYROIDISM
6%
SOMNOLENCE
6%
PROCTALGIA
6%
DYSPNOEA
3%
SEPSIS
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
PNEUMONIA PNEUMOCOCCAL
3%
MULTI-ORGAN FAILURE
3%
INTERSTITIAL LUNG DISEASE
3%
C-REACTIVE PROTEIN INCREASED
3%
CARDIAC FAILURE
3%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
3%
URINARY RETENTION
3%
MENINGITIS
3%
SPINAL COMPRESSION FRACTURE
3%
BLOOD FIBRINOGEN DECREASED
3%
BACK PAIN
3%
SHOCK HAEMORRHAGIC
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pomalidomide Plus Dexamethasone
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (daunorubicin and cytarabine liposome, pomalidomide)Experimental Treatment4 Interventions
INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 14 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial.
Group II: Arm B (daunorubicin and cytarabine liposome)Active Control3 Interventions
INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposome-encapsulated Daunorubicin-Cytarabine
2016
Completed Phase 2
~100
Biospecimen Collection
2004
Completed Phase 2
~1720
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Pomalidomide
2011
Completed Phase 2
~1020
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,703 Previous Clinical Trials
40,931,672 Total Patients Enrolled
Joshua F ZeidnerPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My leukemia is classified as therapy-related or stems from a previous blood disorder.My leukemia diagnosis was confirmed with a specific test showing more than 20% immature blood cells.My condition involves the BCOR gene.My white blood cell count is high, but it can be lowered for treatment.I have received a stem cell transplant from a donor.My cancer has a specific genetic feature (i17q).My cancer has a specific genetic change in chromosome 12.My cancer has a specific genetic change known as idicX(q13).My condition involves EZH2.My condition involves the RUNX1 gene.My condition involves the U2AF1 gene mutation.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I do not have any severe illnesses like heart failure or uncontrolled infections.My hepatitis B virus load is undetectable with treatment.My cancer has a specific genetic change known as del(11q).My cancer has a specific genetic feature (-13/del(13q)).I have no active cancer needing treatment except for certain skin cancers or in situ cervical cancer.I have received a high dose of daunorubicin, especially with past chest radiation.My cancer has a STAG2 mutation.My leukemia is classified as t-AML or AML with MRC by WHO or ICC standards.My AML was caused by previous cancer treatments.I developed a peeling rash from thalidomide or similar drugs.I am allergic to drugs similar to pomalidomide or the components of daunorubicin and cytarabine liposome.My AML is linked to specific genetic changes.I haven't had treatments for my blood disorder in the last 2 weeks and I'm not using strong CYP1A2 inhibitors.My AML has specific mutations and I've only had hydroxyurea or leukapheresis.My cancer has the SF3B1 mutation.My kidneys are functioning well enough to clear waste.I am not pregnant, will use two birth control methods, and agree to regular pregnancy tests.My AML developed from a previous blood disorder.My cancer has a specific genetic abnormality.My condition involves the ASXL1 gene.My AML is linked to certain genetic changes.My cancer has a specific genetic change (-17/add(17p) or del(17p)).My cancer has a specific genetic change known as del(20q).I had hepatitis C but am cured, or I'm being treated with no detectable virus.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I do not have active leukemia in my brain.My condition involves the ZRSR2 gene.My condition involves the SRSF2 gene.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.I am not pregnant or breastfeeding and agree to pregnancy tests if capable of becoming pregnant.I am between 18 and 75 years old and ready for intensive chemotherapy.My cancer has a complex genetic profile with multiple chromosomal abnormalities.I have Wilson's Disease or a copper-related disorder.My AML has mutations related to myelodysplasia.I have AML and have only been treated with hydroxyurea or leukapheresis.My condition involves a -7/del(7q) chromosome abnormality.My cancer has a specific genetic change involving chromosome 5.I can take care of myself but may not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (daunorubicin and cytarabine liposome)
- Group 2: Arm A (daunorubicin and cytarabine liposome, pomalidomide)
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.
Are new participants being signed up for this experiment currently?
"Yes, the information on clinicaltrials.gov does show that this trial is still recruiting patients. The trial was first posted on 6/16/2021 and the most recent update was on 11/15/2022. There are 78 patients enrolled at 3 locations currently."
Answered by AI
How many individuals are participating in this experiment?
"Yes, the information on clinicaltrials.gov point out that this study is currently recruiting candidates. The clinical trial was first posted on 6/16/2021 and was last edited on 11/15/2022. The trial is recruiting for 78 patients at 3 sites."
Answered by AI
Is Pomalidomide a common prescription medication?
"There are currently 364 active clinical trials studying the efficacy of pomalidomide. 78 of those studies have reached Phase 3. New york, New York hosts the most pomalidomide trials, but there are a total of 15305 locations across the world running these sorts of experiments."
Answered by AI
Has the United States Food and Drug Administration cleared Pomalidomide for public consumption?
"Since Pomalidomide is currently in Phase 2 testing, there is not yet enough data to support its efficacy. However, the available safety data rates it as a level 2."
Answered by AI
How has Pomalidomide been shown to be most effective?
"leukemia, myelocytic, acute can be effectively treated by Pomalidomide. Additionally, this medication can help patients suffering from blast phase chronic myelocytic leukemia, lymphoma, and refractory multiple myeloma."
Answered by AI
Might I qualify to be one of the subjects in this experiment?
"This trial is looking for 78 patients with muscular dystrophy who are between 18 and 75 years old. In addition, the following must be true of potential participants: They must have pathological confirmation of AML, they must have >= 20% blasts in bone marrow aspirate and/or biopsy, -7/del(7q), Del(5q)/t(5q), i(17q)/t(17p), -13/del(13q), Del(11q) , they must have therapy-related AML (AML derived from prior chemotherapy or radiation therapy), their AML cannot originate from a"
Answered by AI
Could you please tell me if people who are younger than 50 years old can participate in this research project?
"The eligibility requirements for this particular trial state that all participants must be between 18-75 years old."
Answered by AI
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