Vidaza

multilineage dysplasia, induction chemotherapy, Anemia, Refractory + 11 more

Treatment

4 FDA approvals

20 Active Studies for Vidaza

What is Vidaza

Azacitidine

The Generic name of this drug

Treatment Summary

Azacytidine is a type of drug used to treat cancer. It works by inhibiting an enzyme called DNA methyltransferase, which helps to prevent the growth of tumors. It also works by blocking the production of RNA, which is essential for cell growth. Azacytidine has been used as an anti-cancer drug for many years.

Vidaza

is the brand name

image of different drug pills on a surface

Vidaza Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Vidaza

Azacitidine

2004

34

Approved as Treatment by the FDA

Azacitidine, commonly known as Vidaza, is approved by the FDA for 4 uses like multilineage dysplasia and Leukemia, Myeloid, Acute .

multilineage dysplasia

Leukemia, Myeloid, Acute

Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia

Effectiveness

How Vidaza Affects Patients

Azacitidine is thought to work against cancer by changing the way DNA is made and by killing abnormal cells in the bone marrow. It does this by affecting the way cells use and make DNA. Azacitidine is most effective when cells are rapidly dividing, as normal cells that aren't dividing don't react to it. Once inside cells, it is changed into other forms which disrupt the way the cell makes RNA and proteins, as well as DNA. Azacitidine is most effective when cells are in the S-phase of the cell cycle.

How Vidaza works in the body

Azacitidine is a medication that works by preventing the growth of cancer cells. It does this by blocking the activity of DNA methyltransferase, which stops the cells from reproducing. It also has a toxic effect on the cells, causing them to die. Azacitidine is incorporated into DNA and RNA, which disrupts the cells' ability to produce proteins, which leads to their death.

When to interrupt dosage

The measure of Vidaza is contingent upon the determined condition, including induction chemotherapy, 20-30% blasts and Anemia. The measure of dosage shifts as indicated by the strategy of delivery (e.g. Subcutaneous or Tablet - Oral) specified in the chart below.

Condition

Dosage

Administration

Acute Myeloid Leukemia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Complete Remission

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Anemia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

multilineage dysplasia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Leukemia, Myeloid, Acute

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Blood Transfusion

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

induction chemotherapy

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Complete Blood Count

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Anemia, Refractory

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Chronic Myelomonocytic Leukemia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Anemia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Malignant Neoplasms

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

neutropenia and/or thrombocytopenia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Anemia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Warnings

Vidaza has two prohibitions and should not be taken when you are dealing with any of the conditions given in the following table.

Vidaza Contraindications

Condition

Risk Level

Notes

Liver Neoplasms

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Azacitidine may interact with Pulse Frequency

There are 20 known major drug interactions with Vidaza.

Common Vidaza Drug Interactions

Drug Name

Risk Level

Description

2-Methoxyethanol

Major

The risk or severity of adverse effects can be increased when Azacitidine is combined with 2-Methoxyethanol.

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Azacitidine is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abatacept

Major

The risk or severity of adverse effects can be increased when Azacitidine is combined with Abatacept.

Abetimus

Major

The risk or severity of adverse effects can be increased when Azacitidine is combined with Abetimus.

Acteoside

Major

The risk or severity of adverse effects can be increased when Azacitidine is combined with Acteoside.

Vidaza Toxicity & Overdose Risk

A patient who overdosed on azacitidine reported experiencing diarrhea, nausea, and vomiting. The patient had received a single IV dose of nearly 4 times the recommended starting dose (290 mg/m2).

image of a doctor in a lab doing drug, clinical research

Vidaza Novel Uses: Which Conditions Have a Clinical Trial Featuring Vidaza?

Currently, 367 active studies are examining the potential benefits of Vidaza for treating Chronic Myelomonocytic Leukemia, Blood Transfusion and Multilineage Dysplasia.

Condition

Clinical Trials

Trial Phases

Acute Myeloid Leukemia

267 Actively Recruiting

Phase 2, Phase 3, Phase 1, Phase 4, Not Applicable, Early Phase 1

Complete Remission

0 Actively Recruiting

Chronic Myelomonocytic Leukemia

54 Actively Recruiting

Phase 1, Phase 2, Phase 3, Early Phase 1

Anemia, Refractory

0 Actively Recruiting

Blood Transfusion

0 Actively Recruiting

induction chemotherapy

0 Actively Recruiting

Complete Blood Count

0 Actively Recruiting

Anemia

0 Actively Recruiting

Anemia

0 Actively Recruiting

neutropenia and/or thrombocytopenia

0 Actively Recruiting

Leukemia, Myeloid, Acute

0 Actively Recruiting

Malignant Neoplasms

0 Actively Recruiting

Anemia

0 Actively Recruiting

multilineage dysplasia

0 Actively Recruiting

Vidaza Reviews: What are patients saying about Vidaza?

5

Patient Review

11/16/2012

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

I'm on my 28-day cycle of infusions with Vidaza and things are going great so far. I see vast improvement from when I started and the side effects haven't been too bad.

5

Patient Review

9/18/2013

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

I was able to go without transfusions for 2.5 years while on this drug, which is amazing. I only wish it had worked longer for me. The mild constipation I experienced was my only issue.

5

Patient Review

3/6/2019

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

I've been on Vidaza for over two years now and it's been a life-saver. I'm approaching 250 injections in total, with no negative side effects that I can tell. Blood tests have also been regular, but again – no problems there, either.

4.3

Patient Review

1/22/2010

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

I've been noticing more cramping and weight gain since I started taking Vidaza.

4.3

Patient Review

1/2/2011

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

I'm on my fourteenth cycle of this treatment, which includes five days of consecutive hip injections (200 mg.) daily, followed by a four week break. I was diagnosed with MDS in 1998 and have had approximately 50 units of red packed cells since then. This treatment has allowed me to be transfusion independent for the past twelve months.

3.7

Patient Review

1/5/2012

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

I had really bad constipation and muscle/joint pain before starting this treatment, but even after only seven sessions, the side effects weren't worth it for me.

3.7

Patient Review

9/11/2011

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

I've been on this treatment for 4 cycles now. I used to need a blood or platelet transfusion every single week, but now I haven't needed one in 2 months. My white blood cells have decreased somewhat, but my doctor is still pleased with the overall results. The worst side effects for me are soreness and redness at the injection site, blistering, and constipation.

3.3

Patient Review

5/4/2010

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

I didn't notice any difference.

3.3

Patient Review

1/18/2013

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

I'm currently on my third cycle of this treatment, and I've experienced some mild constipation. My diagnosis is MDS, and since being diagnosed 3/12, I've constantly dealt with hives and skin rash.

3.3

Patient Review

8/4/2015

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

My blood counts were low when I started this treatment, and after the first dose of the first cycle I felt nauseous. So far the drug hasn't helped me, but I'm hoping it will start working soon.

3

Patient Review

5/16/2009

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

2.3

Patient Review

3/31/2010

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

I had seven injections of Vidaza and, surprisingly, I experienced a burst of energy that lasted for hours afterwards with no negative side-effects.

2

Patient Review

5/9/2014

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

I only felt slightly nauseous after taking this medication.

1.7

Patient Review

4/2/2014

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

This drug caused me to develop eosophilic pneumonia, which after only two treatments of Vidaza, almost killed me. It took a huge team of doctors (pulmonologists, cardiologoists and the whole hematologists) to bring me back to some semblance of normalcy. They took me off all MDS meds for three years. I've been okay for three years but now because blood levels have dropped due to a virus, they are wanting me to try another drug. Naturally I am very wary.

1.7

Patient Review

3/17/2017

Vidaza for Bone Marrow Disorders Occurring Before Leukemia

While this medication was still in clinical trials, I was given the opportunity to try it. Unfortunately, after just one cycle my bone marrow function decreased from 50% to 20%. I had to be removed from the trial and underwent a stem cell transplant. Thankfully, that was successful and I've been in remission for seven years now.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about vidaza

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

What is the success rate of Vidaza?

"Vidaza has been shown to help 40% of patients with TP53-mutated myelodysplastic syndromes and acute myeloid leukemia, 20% of whom achieve complete remission. However, the duration of the response is relatively short, and the overall survival rate is six months."

Answered by AI

Is Vidaza considered chemo?

"Azacitadine is the generic name for the cancer drugs Vidaza or Onureg. Sometimes, health care professionals will use the trade name or the generic name when referring to the drug."

Answered by AI

How long can you stay on Vidaza?

"We recommend that patients be treated with azacitidine for at least 6 months, and that in patients who achieve a documented response or stable disease (sd), treatment be continued until disease progression or unacceptable toxicity occurs."

Answered by AI

What is the drug Vidaza used for?

"Azacitidine is a cancer treatment, also called by its brand name, Vidaza. It is a treatment for people who can't have high dose treatment with a stem cell transplant for chronic myelomonocytic leukaemia (CMML) or acute myeloid leukaemia (AML)."

Answered by AI

Clinical Trials for Vidaza

Image of University of California Davis Comprehensive Cancer Center in Sacramento, United States.

Olutasidenib + Azacitidine for Acute Myeloid Leukemia

18+
All Sexes
Sacramento, CA

This phase II trial studies how well giving olutasidenib with azacitidine, followed by olutasidenib maintenance, works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have received prior treatment with venetoclax plus a hypomethylating agent (HMA-Ven). Olutasidenib and azacitidine may inhibit the growth of cancer cells by blocking certain enzymes required for cell growth. Maintenance therapy can help prevent or delay cancer from coming back. Olutasidenib with azacitidine followed by olutasidenib maintenance may be effective in treating patients with IDH1-mutated AML who have received prior HMA-Ven.

Phase 2
Recruiting

University of California Davis Comprehensive Cancer Center

Brian Jonas, MD

Image of University of Virginia in Charlottesville, United States.

CD33 FPBMC for Acute Myelogenous Leukemia

18+
All Sexes
Charlottesville, VA

The purpose of this study is to understand the safety and estimate the efficacy of combining anti-CD3 x anti-CD33 bispecific antibody (CD33Bi) armed fresh peripheral blood mononuclear cells (CD33Bi FPBMC) for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) where they still have detectable disease ("MRD+") after some treatment. Participants receive 4 weekly doses of CD33 FPBMC by intravenous infusion followed by 4-6 weeks of standard treatment with a hypomethylating agent (type of treatment such as decitabine or azacitidine) and possibly a drug called venetoclax. This is considered 1 cycle of study treatment and may be repeated up to 4 times during the study.

Phase 1
Recruiting

University of Virginia

Daniel Reed, MD

Image of The University of Arizona Cancer Center in Tucson, United States.

DLI-X for Leukemia

Any Age
All Sexes
Tucson, AZ

The primary objective of this proposal is to conduct the first-in-human randomized clinical trial evaluating prophylactic DLI-X (pro-DLI-X) for relapse prevention following matched sibling donor (MSD) or haploidentical (haplo) hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. Additionally, the study aims to assess the safety and efficacy of therapeutic DLI-X (t-DLI-X) compared to t-DLI alone in patients with minimal residual disease (MRD+) or overt relapse post-alloHCT. For patients with CD19-positive lymphoid malignancies, the study will incorporate blinatumomab, while those with myeloid or CD19-negative lymphoid malignancies will receive t-DLI-X or t-DLI alone. We hypothesize that both pro-DLI-X and t-DLI-X, with or without blinatumomab, will demonstrate safety and superior efficacy by enhancing graft-versus-leukemia (GvL) effects mediated by natural killer (NK) cells, γδ T cells, and CD8+ T cells, while maintaining manageable and treatment-responsive graft-versus-host disease (GvHD).

Phase 1
Waitlist Available

The University of Arizona Cancer Center

Emmanuel Katsanis, MD

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Image of OHSU Knight Cancer Institute in Portland, United States.

Fludarabine + Cytarabine + Idarubicin + Venetoclax for Acute Myeloid Leukemia

18 - 65
All Sexes
Portland, OR

This phase II trial compares induction and consolidation therapy with fludarabine, cytarabine, idarubicin, and venetoclax to cytarabine and daunorubicin induction and cytarabine consolidation for the treatment of acute myeloid leukemia (AML). Patients with AML often receive induction and consolidation therapy. Induction therapy is given first to get the patient's AML under control (remission). Consolidation therapy is given after the cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body. Chemotherapy drugs, such as fludarabine, cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving fludarabine, cytarabine, idarubicin, and venetoclax for induction and consolidation therapy may be more effective in treating AML.

Phase 2
Waitlist Available

OHSU Knight Cancer Institute

Curtis A Lachowiez

Image of Brigham and Women's Hospital in Boston, United States.

Tagraxofusp + Venetoclax + Azacitidine for Acute Myeloid Leukemia

18+
All Sexes
Boston, MA

The purpose of this research study is to test the safety and efficacy of a new drug combination with three agents, azacitidine, venetoclax and tagraxofusp. Leftover (residual) leukemia disease that is not visible by eye can be increase the chance of disease recurrence. This research study is to determine if the combination therapy can safely help to control residual Acute Myeloid Leukemia (AML) and to prevent disease recurrence. The names of the study drugs involved in this study are: * Tagraxofusp (a type of CD123-directed cytotoxin) * Azacitidine (a type of standard of care cytidine nucleoside analog) * Venetoclax (a type of standard of care BCL-2 inhibitor)

Phase 1 & 2
Recruiting

Brigham and Women's Hospital (+1 Sites)

Jacqueline Garcia, MD

Stemline Therapeutics, Inc.

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Image of Fred Hutch/University of Washington Cancer Consortium in Seattle, United States.

Treatment Intensity for Acute Myeloid Leukemia

18+
All Sexes
Seattle, WA

This clinical trial studies whether less fit adults with acute myeloid leukemia (AML) or myeloid neoplasms are willing to let a computer program decide (randomization) whether they receive lower- or higher-intensity chemotherapy. Historically, treatment decision-making for patients with AML or myeloid neoplasms has divided patients into two categories, with patients considered fit receiving intensive "curative" chemotherapy, and patients considered unfit, such as older patients with a higher risk of early death from therapy, receiving non-intensive "palliative" therapy or no therapy. With the introduction of new treatment agents, it has become difficult to determine the difference between intensive and non-intensive therapy, especially for patients considered unfit for whom treatment-related side effects remain a concern. Treatment intensity is best identified through randomized trials but often patients are unwilling to undergo randomization due to preset beliefs. However, with improved supportive care and the awareness that new treatment agents may have similar risks as intensive therapy, it may be possible that more patients are willing to be randomized. This may help identify the best treatment intensity for less fit adults with AML or myeloid neoplasms, which may improve outcomes.

Waitlist Available
Has No Placebo

Fred Hutch/University of Washington Cancer Consortium

Jacob Appelbaum, MD, PhD

Image of Houston Methodist Neal Cancer Center in Houston, United States.

Hypomethylating Agents vs. Intensive Chemotherapy for Acute Myeloid Leukemia

18+
All Sexes
Houston, TX

This is a therapeutic intervention trial evaluating the clinical utility of a novel blood-based epigenetic biomarker-genome-wide 5-hydroxymethylcytosine (5hmC) in cell-free DNA (cfDNA)-for assessing measurable residual disease (MRD) in patients with newly diagnosed acute myeloid leukemia (AML). The study compares the efficacy of hypomethylating agent (HMA)-based therapy versus intensive induction chemotherapy, using the 5hmC biomarker to guide post-induction treatment decisions. Approximately 112 adult patients will be enrolled and assigned to treatment arms based on a stratified sampling scheme. Blood samples will be collected at defined intervals to assess MRD status. Primary endpoints include minimal residual disease (MRD) negativity rate, duration of remission, event-free survival (EFS), and overall survival (OS).

Phase 2
Waitlist Available

Houston Methodist Neal Cancer Center

Shilpan Shah, MD

Image of Texas Children's Cancer and Hematology Center in Houston, United States.

Combination Therapy for Pediatric Acute Myeloid Leukemia

1 - 30
All Sexes
Houston, TX

This research study investigates the tolerability of substituting two cycles of chemotherapy into the standard pediatric acute myeloid leukemia (AML) chemotherapy treatment regimen for patients with newly diagnosed AML at intermediate-risk (IR) and high-risk (HR) of relapse. The goal is to achieve similar or better survival with chemotherapy cycles that are intensive but less likely to cause long-term complications. Patients will enroll on this trial at the end of their first induction cycle. The two cycles to be substituted are: * "Ida-FLA" (idarubicin+fludarabine/cytarabine) as Induction 2 * "VIA" (venetoclax+idarubicin+cytarabine) as Intensification 1 of the HR treatment regimen, and Intensification 2 of the IR treatment backbone. Researchers will evaluate side effects and outcomes for up to three years after enrollment. Participants will also have the opportunity to participate in optional research studies including patient surveys and blood and bone marrow sample testing.

Phase < 1
Recruiting

Texas Children's Cancer and Hematology Center

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We made a collection of clinical trials featuring Vidaza, we think they might fit your search criteria.
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