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Anti-metabolites
Guadecitabine for Myelodysplastic Syndromes
Phase 2
Waitlist Available
Led By Guillermo Garcia-Manero
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to entering this study
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests how well guadecitabine works in treating patients with myelodysplastic syndromes that are at a higher risk of developing acute myeloid leukemia. Guadecitabine may stop cancer cell growth by blocking some of the enzymes needed for cell growth.
Who is the study for?
This trial is for adults with high-risk Myelodysplastic Syndromes (MDS) that could turn into acute leukemia. They shouldn't have had intensive chemo or certain drugs before, and their organs must function well. They need to understand the study's risks and benefits, not be pregnant or breastfeeding, and agree to use effective birth control.Check my eligibility
What is being tested?
The trial tests Guadecitabine's effectiveness in treating high-risk MDS. It aims to see if this drug can stop cancer cells from growing by blocking enzymes they need. This phase II trial will determine how well patients respond to the treatment.See study design
What are the potential side effects?
Guadecitabine may cause side effects like fatigue, nausea, fever, pain at injection site, low blood cell counts leading to infection risk or bleeding problems. Side effects vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who can have children and I have a negative pregnancy test from the last 2 weeks.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My MDS is considered high risk based on IPSS or WHO criteria.
Select...
I have not had high-dose chemotherapy.
Select...
I understand the study's risks and benefits and can consent.
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
Complete response rates
Secondary outcome measures
Event-free survival
Incidence of adverse events
Mortality rate
+3 moreSide effects data
From 2020 Phase 3 trial • 417 Patients • NCT0290735934%
Neutropenia
31%
Thrombocytopenia
30%
Febrile Neutropenia
27%
Pneumonia
23%
Anaemia
23%
Constipation
22%
Diarrhoea
22%
Fatigue
22%
Pyrexia
20%
Asthenia
18%
Decreased Appetite
17%
Injection Site Reaction
17%
Hypokalaemia
16%
Epistaxis
16%
Nausea
16%
Oedema Peripheral
14%
Stomatitis
14%
Cough
13%
Dizziness
13%
Headache
12%
Back Pain
12%
Leukopenia
12%
Dyspnoea
11%
Insomnia
11%
Vomiting
10%
Rash
10%
Sepsis
10%
Abdominal Pain
9%
Petechiae
9%
Contusion
8%
Weight Decreased
8%
Cellulitis
7%
Arthralgia
7%
Pruritus
6%
Fall
6%
Musculoskeletal Pain
6%
Septic Shock
6%
Upper Respiratory Tract Infection
6%
Transfusion Reaction
6%
Pain In Extremity
6%
Haematoma
6%
Haemorrhoids
6%
Hypotension
5%
Urinary Tract Infection
5%
Blood Creatinine Increased
5%
Hypomagnesaemia
5%
Oropharyngeal Pain
5%
Erythema
5%
Oedema
5%
Alanine Aminotransferase Increased
4%
Nasopharyngitis
4%
Aspartate Aminotransferase Increased
4%
Bacteraemia
2%
Atrial Fibrillation
1%
Cardiac Failure Congestive
1%
Acute Myocardial Infarction
1%
General Physical Health Deterioration
1%
Subcutaneous Abscess
1%
Cholangitis
1%
Pulmonary Embolism
1%
Tumour Lysis Syndrome
1%
Angina Pectoris
1%
Colitis
1%
Anal Abscess
1%
Device Related Infection
1%
Cardiac Failure
1%
Gastrointestinal Haemorrhage
1%
Lower Gastrointestinal Haemorrhage
1%
Multiple Organ Dysfunction Syndrome
1%
Bronchopulmonary Aspergillosis
1%
Infection
1%
Urosepsis
1%
Bronchitis
1%
Cellulitis Orbital
1%
Chronic Sinusitis
1%
Corynebacterium Infection
1%
Pseudomonal Bacteraemia
1%
Sinusitis
1%
Staphylococcal Bacteraemia
1%
Subarachnoid Haemorrhage
1%
Haematuria
1%
Respiratory Tract Infection
1%
Haemorrhage Intracranial
1%
Prostatitis
1%
Febrile Bone Marrow Aplasia
1%
Leukocytosis
1%
Leukostasis Syndrome
1%
Pancytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Guadecitabine
Treatment Choice
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (guadecitabine)Experimental Treatment1 Intervention
Patients receive guadecitabine SC on days 1-5. Treatment repeats every 4-8 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 3 courses are taken off therapy after 6 courses. Patients may continue to receive treatment after 24 courses if the investigator determines it is in the patient's best interest.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guadecitabine
2014
Completed Phase 3
~570
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,418 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,145 Total Patients Enrolled
Guillermo Garcia-ManeroPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
1,487 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I stopped chemotherapy 2 weeks ago and have no lasting side effects, unless my cancer is quickly getting worse.I am a woman who can have children and I have a negative pregnancy test from the last 2 weeks.I haven't taken any experimental drugs or cancer treatments in the last 2 to 4 weeks.I do not have severe diseases or serious organ problems that could make treatment risky for me.I have an ongoing infection that hasn't improved with treatment.I can take care of myself but might not be able to do heavy physical work.My MDS is considered high risk based on IPSS or WHO criteria.I am not on any cancer treatments not listed in the study guidelines.I have another type of cancer at the same time.I have not had high-dose chemotherapy.I have had only one cycle or less of specific cancer treatments.I am taking hydroxyurea to manage my blood counts before treatment.I am allowed to use medications that help with blood cell growth.I understand the study's risks and benefits and can consent.I am using or willing to use approved birth control methods during and 8 weeks after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (guadecitabine)
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.
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