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Dexrazoxane for Blood Cancer Side Effects

Phase 2
Recruiting
Led By Maro Ohanian
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
Patients with myeloproliferative neoplasms in blast phase will be eligible.
Patients with isolated extramedullary myeloid neoplasm will be eligible.
Must not have
Active heart disease defined as: Unstable coronary syndromes, unstable or severe angina, recent myocardial infarction (MI) within 6 months
Severe valvular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how well dexrazoxane hydrochloride prevents heart-related side effects of chemotherapy in people with blood cancers.

Who is the study for?
This trial is for adults with certain blood cancers like acute myeloid leukemia or chronic myeloid leukemia, who haven't had more than three cycles of chemotherapy. They should have a heart function test showing normal results and agree to use contraception. It's not for those with severe heart disease, recent heart attacks, uncontrolled psychiatric illness, known allergies to the drugs used in the study, or women who are pregnant or breastfeeding.
What is being tested?
The trial is testing dexrazoxane hydrochloride's ability to prevent heart damage from chemotherapy in patients with various blood cancers. Participants will receive standard chemo drugs along with dexrazoxane to see if it reduces cardiac side effects compared to usual care without dexrazoxane.
What are the potential side effects?
Dexrazoxane may cause nausea, fatigue, low blood cell counts increasing infection risk, and possible allergic reactions. The other chemo drugs can also cause similar side effects including hair loss and mouth sores. Heart-related side effects are what this study aims to reduce.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood cancer is in an advanced stage.
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My cancer is a type of leukemia affecting areas outside the bone marrow.
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I have an active brain or spinal cord condition.
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I have been diagnosed with AML, high-risk MDS, or a high-risk myeloproliferative neoplasm.
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I have been diagnosed with AML, high-risk MDS, or a high-risk myeloproliferative neoplasm.
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My condition is in the advanced stage of a blood cancer.
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I have a type of blood cancer that affects areas outside of my bone marrow.
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I have an active brain or spinal cord condition.
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I am in the first group for treatment and have had 3 or fewer rounds of chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a recent heart attack or severe heart issues in the last 6 months.
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I have a serious heart valve problem.
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I have a history of heart artery disease.
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I have worsening heart failure symptoms.
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I have serious heart rhythm problems.
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I am not pregnant or breastfeeding.
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I am of childbearing age and do not use birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of patients experiencing a decrease in left ventricular ejection fraction (LVEF)
Secondary study objectives
Assessment of change in troponin I and high-sensitivity troponin T
Incidence of cardiac symptoms
Recurrence-free survival
Other study objectives
Assessment of metal chelation effects of dexrazoxane and chemotherapy
Assessment of minimal residual disease (MRD)

Side effects data

From undefined Phase 3 trial • 1734 Patients • NCT00025259
80%
Neutrophil count decreased
42%
Anemia
31%
Platelet count decreased
26%
Febrile neutropenia
18%
White blood cell decreased
16%
Infections and infestations - Other, specify
9%
Blood and lymphatic system disorders - Other, specify
5%
Lymphocyte count decreased
3%
Catheter related infection
3%
Dehydration
2%
Abdominal pain
2%
Mucositis oral
2%
Vomiting
2%
Anaphylaxis
2%
Hypokalemia
2%
Hypotension
1%
Hyponatremia
1%
Hypoxia
1%
Myalgia
1%
Depression
1%
Immune system disorders - Other, specify
1%
Dizziness
1%
Constipation
1%
Esophagitis
1%
Ileus
1%
Pain
1%
Carbon monoxide diffusing capacity decreased
1%
Hypoalbuminemia
1%
Neuralgia
1%
Peripheral sensory neuropathy
1%
Dyspnea
1%
Diarrhea
1%
Typhlitis
1%
Hyperglycemia
1%
Headache
1%
Seizure
1%
Syncope
1%
Nausea
1%
Cardiac disorders - Other, specify
1%
Hypophosphatemia
1%
Bone pain
1%
Peripheral motor neuropathy
1%
Thromboembolic event
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm III (RER With CR [ABVE-PC])
Arm I (Patients Off-therapy Before Callback-Induction Only)
Arm II (RER With CR [ABVE-PC, IFRT])
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
Arm VII (SER [ABVE-PC, IFRT])
Arm VI (SER [DECA, ABVE-PC, IFRT])
Arm V (RER With PD)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive care (dexrazoxane hydrochloride, chemotherapy)Experimental Treatment5 Interventions
See detailed description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Idarubicin
2014
Completed Phase 4
~4380
Cytarabine
2016
Completed Phase 3
~3330
Cladribine
2014
Completed Phase 4
~4650
Dexrazoxane Hydrochloride
2013
Completed Phase 1
~50
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~460

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,111,983 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,226 Total Patients Enrolled
Maro OhanianPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Cytarabine Clinical Trial Eligibility Overview. Trial Name: NCT03589729 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Supportive care (dexrazoxane hydrochloride, chemotherapy)
Acute Myeloid Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT03589729 — Phase 2
Cytarabine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03589729 — Phase 2
~14 spots leftby Dec 2025
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