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Anti-metabolites

Entinostat + 5AC for Acute Myeloid Leukemia

Q: What is the enrollment capacity of this clinical trial?

At the moment, this study is not actively seeking participants. It was first posted on July 1st 2011 and last edited 8th May 2023. For those looking for other trials, there are currently 1581 studies recruiting patients with acute myeloid <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> and 182 studies that require individuals to take B: 5AC days 1-10 / entinostat days 10,17.

Q: Has the FDA granted authorization for a regimen of B: 5AC administered on days 1-10 in conjunction with entinostat on day 10 and 17?

Given the Phase 2 nature of this trial, which indicates that there is some data indicating safety but none supporting efficacy, we at Power rate the security of B: 5AC days 1-10 / entinostat days 10,17 as a two.

Q: What conditions is the B: 5AC days 1-10 / entinostat days 10,17 medication regimen typically used to treat?

B: 5AC administered days 1-10, in tandem with entinostat on day 10 and 17 can be beneficial to individuals suffering from malignant neoplasms, 20-30% blasts, or neutropenia/thrombocytopenia.

Q: Has there been prior experimentation with a B: 5AC days 1-10 / entinostat days 10,17 regimen?

Initially studied at Chinese University of Hong Kong-Prince of Wales Hospital in 2006, the B: 5AC days 1-10 / entinostat days 10,17 protocol has now been tested across 197 clinical trials. Presently, 182 studies are actively being conducted - many out of Cleveland, <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>.

Q: Are any new participants being sought for this clinical investigation?

At this moment in time, the medical trial is no longer open to new patients. It first appeared on July 1st 2011 and its status was last updated on May 8th 2023. For those seeking alternative studies, 1581 investigations related to acute myeloid <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> are currently recruiting while 182 further trials pertaining to B: 5AC days 1-10 / entinostat days 10,17 are also accepting participants.

Phase 2

Waitlist Available

Led By Hetty Carraway, MD

Research Sponsored by Hetty Carraway

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Normal organ function as defined below: Creatinine < 2 mg/dl, Total serum bilirubin within institutional limits unless due to hemolysis, Gilbert's syndrome, or ineffective erythropoiesis, AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal, Life expectancy of at least three months

ECOG performance status 0, 1, or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 cycles (420 days)

Awards & highlights

Study Summary

This trial is researching how best to use two drugs to help treat acute myeloid leukemia (AML). Results so far have been promising.

Who is the study for?

This trial is for elderly patients with Acute Myeloid Leukemia who can't undergo standard chemotherapy, have a life expectancy of at least three months, and are not suitable for stem cell transplant. They must understand the study's nature and give consent. Participants should not have active infections or recent treatments that could interfere with the study.Check my eligibility

What is being tested?

The trial tests two drugs, 5AC (5-azacitidine) and entinostat, to see how they work together against AML when given on different schedules. The goal is to find out if changing the timing of these drugs improves patient outcomes compared to previous studies where they were administered simultaneously.See study design

What are the potential side effects?

Potential side effects include blood count changes, organ inflammation due to immune response, fatigue from treatment-related stress on the body, digestive issues like nausea or constipation from medication interactions, and increased risk of infection due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I do not have any untreated active infections.

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I am not eligible for or have declined a stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 cycles (420 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 cycles (420 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 cycles (420 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Leukemia, Myelocytic, Acute

To estimate the overall response rate following treatment in patients with AML ≥ 60 years old who are unable to tolerate or decline cytotoxic chemotherapy or those who have relapsed despite one prior regimen.

Secondary outcome measures

To evaluate changes in DNA damage in response to combination therapy using gammaH2AX determination by western blotting.

To evaluate duration of response.

To evaluate the effect of entinostat on the induction of hyperacetylation of histones from peripheral blood and/or bone marrow samples.

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: B: 5AC days 1-10 / entinostat days 10,17Experimental Treatment2 Interventions

In Arm B the agents will be administered sequentially with 5AC given at 50mg/m2 subcutaneously daily for 10 days on days 1 - 10 of a 28 day cycle followed by entinostat at a 8 mg flat dose on days 10 and 17.

Group II: A: 5AC days 1-10 / entinostat days 3, 10Experimental Treatment2 Interventions

Arm A will be given an overlapping schedule of drugs with 5AC given at 50mg/m2 subcutaneously daily for 10 days on days 1 - 10 of a 28 day cycle and entinostat given at a flat dose of 8 mg orally on days 3 and 10.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hetty CarrawayLead Sponsor

Hetty Carraway, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Media Library

5AC (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT01305499 — Phase 2

Acute Myeloid Leukemia Research Study Groups: B: 5AC days 1-10 / entinostat days 10,17, A: 5AC days 1-10 / entinostat days 3, 10

Acute Myeloid Leukemia Clinical Trial 2023: 5AC Highlights & Side Effects. Trial Name: NCT01305499 — Phase 2

5AC (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01305499 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment capacity of this clinical trial?

"At the moment, this study is not actively seeking participants. It was first posted on July 1st 2011 and last edited 8th May 2023. For those looking for other trials, there are currently 1581 studies recruiting patients with acute myeloid leukemia and 182 studies that require individuals to take B: 5AC days 1-10 / entinostat days 10,17."

Answered by AI

Has the FDA granted authorization for a regimen of B: 5AC administered on days 1-10 in conjunction with entinostat on day 10 and 17?

"Given the Phase 2 nature of this trial, which indicates that there is some data indicating safety but none supporting efficacy, we at Power rate the security of B: 5AC days 1-10 / entinostat days 10,17 as a two."

Answered by AI

What conditions is the B: 5AC days 1-10 / entinostat days 10,17 medication regimen typically used to treat?

"B: 5AC administered days 1-10, in tandem with entinostat on day 10 and 17 can be beneficial to individuals suffering from malignant neoplasms, 20-30% blasts, or neutropenia/thrombocytopenia."

Answered by AI

Has there been prior experimentation with a B: 5AC days 1-10 / entinostat days 10,17 regimen?

"Initially studied at Chinese University of Hong Kong-Prince of Wales Hospital in 2006, the B: 5AC days 1-10 / entinostat days 10,17 protocol has now been tested across 197 clinical trials. Presently, 182 studies are actively being conducted - many out of Cleveland, Ohio."

Answered by AI

Are any new participants being sought for this clinical investigation?

"At this moment in time, the medical trial is no longer open to new patients. It first appeared on July 1st 2011 and its status was last updated on May 8th 2023. For those seeking alternative studies, 1581 investigations related to acute myeloid leukemia are currently recruiting while 182 further trials pertaining to B: 5AC days 1-10 / entinostat days 10,17 are also accepting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Evaluate Two Schedules of MS275 in Combination With 5AC in Elderly Patients With Acute Myeloid Leukemia (AML)

Hetty Carraway 2011. "A Trial to Evaluate Two Schedules of MS275 in Combination With 5AC in Elderly Patients With Acute Myeloid Leukemia (AML)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01305499.

All > Acute Myeloid Leukemia > Aml