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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients experiencing a decrease in left ventricular ejection fraction (LVEF)
Secondary outcome measures
Assessment of change in troponin I and high-sensitivity troponin T
Complete remission (CR) /complete remission with incomplete blood count recovery (CRi) rates (Cohorts 1-3)
Event-free survival (Cohorts 1-3)
+6 moreOther outcome measures
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 • NCT0002525980%
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%
Depression
1%
Hyponatremia
1%
Immune system disorders - Other, specify
1%
Hypoxia
1%
Myalgia
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)
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
~4330
Cytarabine
2016
Completed Phase 3
~3310
Cladribine
2014
Completed Phase 4
~4390
Dexrazoxane Hydrochloride
2013
Completed Phase 1
~50
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~440
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,805 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,221 Total Patients Enrolled
Maro OhanianPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood cancer is in an advanced stage.My cancer is a type of leukemia affecting areas outside the bone marrow.I have an active brain or spinal cord condition.I agree to use birth control during the study.I have untreated CML in the blast phase or Ph+ AML.I am in or past my 3rd relapse of cancer and have active disease or am in remission but had limited chemotherapy.I have been diagnosed with AML, high-risk MDS, or a high-risk myeloproliferative neoplasm.I have untreated CML in the blast phase or Ph+ AML.I have not had a recent heart attack or severe heart issues in the last 6 months.I have a serious heart valve problem.I have a history of heart artery disease.I have been diagnosed with AML, high-risk MDS, or a high-risk myeloproliferative neoplasm.I understand the study's requirements and have signed the consent.I have received treatments like hydroxyurea or chemotherapy for my condition.I am in my 1st or 2nd relapse of cancer and have had 3 or fewer chemo cycles for the latest complete response.I am not pregnant or breastfeeding.I am of childbearing age and do not use birth control.My condition is in the advanced stage of a blood cancer.I am in or beyond my third treatment attempt for my cancer and either still have active disease or am in remission after less than four chemotherapy cycles.I am in complete remission and my doctor recommends maintenance therapy.I have worsening heart failure symptoms.I have serious heart rhythm problems.I am in the first group for treatment and have had 3 or fewer rounds of chemotherapy.I am in my first or second relapse of cancer and have had 3 or fewer chemotherapy cycles for the most recent complete response.I have a type of blood cancer that affects areas outside of my bone marrow.I have an active brain or spinal cord condition.I have received treatments like hydroxyurea or chemotherapy for my condition.I am in the first group for treatment and have had 3 or fewer rounds of chemotherapy.I agree to use birth control during the study.My high bilirubin levels are due to Gilbert's syndrome.I understand the study's requirements and have signed the consent form.My high bilirubin levels are due to Gilbert's syndrome.I am in complete remission and my doctor recommends maintenance therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (dexrazoxane hydrochloride, chemotherapy)
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 there still opportunities for individuals to enroll in this scientific trial?
"Confirmed. Clinicaltrials.gov presents evidence that this study, which was published on 19th September 2018, is still recruiting participants. It is estimated that 100 individuals will be examined over the course of 1 site of investigation."
Answered by AI
Is there any risk associated with administering Cytarabine to patients?
"Our team evaluated the safety of Cytarabine on a scale from 1-3 and rated it as 2, reflecting that while there is supportive evidence for its security, there are no studies to suggest efficacy."
Answered by AI
What is the scale of this clinical trial's enrolment?
"Yes, the available information on clinicaltrials.gov reveals that this trial is in need of candidates. First posted on September 19th 2018, and amended as recently as January 31st 2022, it seeks to include 100 individuals at 1 medical centre."
Answered by AI
What previous investigations have focused on the efficacy of Cytarabine?
"Currently, 276 clinical trials involving Cytarabine are in progress with 69 of these trials being Phase 3. Of the 11072 locations conducting research on this drug, a significant portion is situated within New york City."
Answered by AI
In what scenarios is Cytarabine typically employed?
"Typically, cytarabine is used to treat meningeal leukemia. This medication can also be beneficial for those suffering from acute myeloid leukemia, certain pediatric leukemias, blast phase chronic myelocytic leukemia and prevent cardiomyopathy."
Answered by AI
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