Myleran

conditioning regimens for allogeneic stem cell transplantation therapy, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Thrombocythemia, Essential + 2 more

Treatment

3 FDA approvals

20 Active Studies for Myleran

What is Myleran

Busulfan

The Generic name of this drug

Treatment Summary

Busulfan is a medication used to reduce the activity of bone marrow, usually prescribed as a palliative treatment for chronic myeloid leukemia. Although it provides relief of symptoms, it does not bring about permanent remission. The National Toxicology Program has classified busulfan as a known carcinogen.

Myleran

is the brand name

Myleran Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Myleran

Busulfan

1985

22

Approved as Treatment by the FDA

Busulfan, also known as Myleran, is approved by the FDA for 3 uses including allogeneic hematopoietic stem cell transplant, Chronic myelogenous leukemia and Leukemia, Myelogenous, Chronic, BCR-ABL Positive .

allogeneic hematopoietic stem cell transplant, Chronic myelogenous leukemia

Used to treat allogeneic hematopoietic stem cell transplant, Chronic myelogenous leukemia in combination with Cyclophosphamide

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Used to treat allogeneic hematopoietic stem cell transplant, Chronic myelogenous leukemia in combination with Cyclophosphamide

conditioning regimens for allogeneic stem cell transplantation therapy

Used to treat conditioning regimens for allogeneic stem cell transplantation therapy in combination with Cyclophosphamide

Effectiveness

How Myleran Affects Patients

Busulfan is a drug used to treat cancer and belongs to a class of drugs called alkylating agents. These drugs work by attaching alkyl groups to certain molecules, which prevents cells from replicating and dividing. In addition, alkylating agents can alter the coding of DNA, which can lead to cell death. It is believed that the overexpression of a certain enzyme (MGST2) may make some people resistant to busulfan, although the exact role of MGST2 in busulfan metabolism is unknown.

How Myleran works in the body

Busulfan works by damaging DNA. When it enters the cell, it is broken down and releases two carbonium ions. These ions then attach to and damage DNA molecules, preventing the cell from making copies of itself and reproducing. The damage caused by busulfan is irreversible and the cell eventually dies.

When to interrupt dosage

The recommended measure of Myleran is contingent upon the identified condition, such as Polycythemia Vera (PV), conditioning regimens for allogeneic stem cell transplantation therapy and Leukemia. The quantity of dosage depends on the technique of delivery, as outlined in the table beneath.

Condition

Dosage

Administration

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

2.0 mg, , 6.0 mg/mL, 60.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Solution, Intravenous, Solution - Intravenous, Tablet - Oral, Tablet, Injection, Injection - Intravenous, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, Injection, solution - Intravenous, Injection, solution

Polycythemia Vera

2.0 mg, , 6.0 mg/mL, 60.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Solution, Intravenous, Solution - Intravenous, Tablet - Oral, Tablet, Injection, Injection - Intravenous, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, Injection, solution - Intravenous, Injection, solution

conditioning regimens for allogeneic stem cell transplantation therapy

2.0 mg, , 6.0 mg/mL, 60.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Solution, Intravenous, Solution - Intravenous, Tablet - Oral, Tablet, Injection, Injection - Intravenous, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, Injection, solution - Intravenous, Injection, solution

Thrombocythemia, Essential

2.0 mg, , 6.0 mg/mL, 60.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Solution, Intravenous, Solution - Intravenous, Tablet - Oral, Tablet, Injection, Injection - Intravenous, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, Injection, solution - Intravenous, Injection, solution

Leukemia

2.0 mg, , 6.0 mg/mL, 60.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Solution, Intravenous, Solution - Intravenous, Tablet - Oral, Tablet, Injection, Injection - Intravenous, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, Injection, solution - Intravenous, Injection, solution

Warnings

Myleran has one contraindication and should not be administered in conjunction with any of the states listed in the table below.

Myleran Contraindications

Condition

Risk Level

Notes

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Do Not Combine

There are 20 known major drug interactions with Myleran.

Common Myleran Drug Interactions

Drug Name

Risk Level

Description

2-Methoxyethanol

Major

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

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

Major

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

Abetimus

Major

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

Acteoside

Major

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

Aldosterone

Major

The risk or severity of adverse effects can be increased when Busulfan is combined with Aldosterone.

Myleran Toxicity & Overdose Risk

Signs of an overdose on ibuprofen include an allergic reaction, signs of internal bleeding, sudden weakness or exhaustion, persistent coughing or difficulty breathing, stomach or joint pain, severe nausea or diarrhea, dizziness or confusion, skin discoloration, and chills. In serious cases, a person may faint or even lose consciousness.

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

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

56 active clinical trials are underway to investigate the potential of Myleran to ameliorate Thrombocythemia, Essential Leukemia and Polycythemia Vera (PV).

Condition

Clinical Trials

Trial Phases

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

0 Actively Recruiting

Leukemia

156 Actively Recruiting

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

Thrombocythemia, Essential

25 Actively Recruiting

Phase 2, Phase 1, Phase 3

Polycythemia Vera

0 Actively Recruiting

conditioning regimens for allogeneic stem cell transplantation therapy

0 Actively Recruiting

Myleran Reviews: What are patients saying about Myleran?

5

Patient Review

8/27/2016

Myleran for Type of Leukemia - Chronic Myelogenous Leukemia

image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about myleran

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

What is myleran used for?

"Myleran is a medication used to improve the quality of life and relieve cancer symptoms for people with chronic myelogenous leukemia. It is classified as an alkylating agent."

Answered by AI

What is busulfan used for?

"Busulfan is used in combination with cyclophosphamide to prepare a person for allogeneic hematopoietic progenitor cell transplantation, which is a treatment for chronic myelogenous leukemia. Busulfan is an alkylating agent, a group of medicines that work by causing changes in the DNA of cells."

Answered by AI

What is paraplatin used for?

"Paraplatin is a medication used to treat ovarian cancer, as well as other types of cancer such as lung, head and neck, endometrial, esophageal, bladder, breast, and cervical cancer. It is also used to treat central nervous system or germ cell tumors, osteogenic sarcoma, and to prepare for a stem cell or bone marrow transplant."

Answered by AI

Is Myleran chemotherapy?

"Myleran is a chemotherapy drug that is used to treat cancer."

Answered by AI

Clinical Trials for Myleran

Image of Mass General Brigham in Boston, United States.

WELL-MPN App for Myeloproliferative Neoplasms

18+
All Sexes
Boston, MA

The goal of this clinical trial is to learn whether a digital lifestyle app can help improve diet, physical activity, symptoms, emotional well-being, and quality of life in adults with myeloproliferative neoplasms (MPNs). The main questions it aims to answer are: Can people with MPNs use the WELL-MPN app? Does using the WELL-MPN app improve diet quality and physical activity? Does the WELL-MPN app improve MPN-related symptoms, anxiety and depression, confidence in managing health, and overall quality of life? Researchers will compare participants who use the WELL-MPN digital app with participants who receive written educational materials about diet and physical activity for people with cancer to see if the app leads to greater improvements in lifestyle behaviors, symptoms, and well-being. Participants will: Be randomly assigned to use the WELL-MPN app or receive written lifestyle education materials Use the assigned program or materials over the study period Complete surveys about diet, physical activity, symptoms, mood, confidence in self-care, and quality of life

Waitlist Available
Has No Placebo

Mass General Brigham

Chi-Joan How

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 MD Anderson in Houston, United States.

Cyclophosphamide-Based Prophylaxis for Leukemia

18 - 66
All Sexes
Houston, TX

The purpose of this clinical trial is to compare drug combinations to learn which drugs work best to prevent graft-versus-host-disease (GVHD) in people who have received a stem cell transplant. The source of stem cells is from someone who is not related and has a different blood cell type than the study participant. The researchers will compare the new drug combination to a standard drug combination. They will also learn about the safety of each drug combination. Participants will: * Receive the standard or new drug combination after transplant * Visit the doctor's office for check-ups and tests after transplant that are routine for most transplant patients * Take surveys about physical and emotional well-being * Give blood and stool samples.

Phase 2
Recruiting

MD Anderson (+2 Sites)

Incyte Corporation

Image of University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center in Cleveland, United States.

Abatacept for Leukemia

18 - 65
All Sexes
Cleveland, OH

The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT. Participants will: * Partake in exams, tests, and procedures as part of usual cancer care. * Partake in conditioning, which is the treatment that is given before a transplant. * Have a cord blood transplant. * Partake in radiation following the transplant.

Phase 2
Recruiting

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Leland Metheny, MD

Image of City of Hope Comprehensive Cancer Center LAO in Duarte, United States.

ASTX727 + Iadademstat for Myeloproliferative Disorders

18+
All Sexes
Duarte, CA

This phase II trial compares the effect of ASTX727 in combination with iadademstat to ASTX727 alone in treating patients with accelerated or blast phase Philadelphia chromosome negative myeloproliferative neoplasms (MPNs). ASTX727 is a combination of two drugs, cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ASTX727 in combination with iadademstat may be more effective than ASTX727 alone in treating patients with accelerated or blast phase Philadelphia chromosome negative MPNs.

Phase 2
Recruiting

City of Hope Comprehensive Cancer Center LAO (+23 Sites)

Anand A Patel

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Image of Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, United States.

Darzalex Faspro for Blood Cancers

18+
All Sexes
Baltimore, MD

This research is being done to investigate the safety and effectiveness of Darzalex Faspro (daratumumab and hyaluronidase-fihj) (a monoclonal antibody that targets plasma cells that make antibodies) and whether it can lower donor specific antibodies (DSA) levels to low enough levels to permit patients to proceed with allogeneic peripheral blood transplant (alloBMT). Those being asked to participate have high DSA levels that puts those being asked to participate at high risk of rejecting the available donor's blood stem cells and making those being asked to participate ineligible to receive a stem cell transplant.

Phase < 1
Recruiting

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Christian B Gocke, MD, PhD

Janssen Research & Development, LLC

Image of University of Michigan ( Site 6000) in Ann Arbor, United States.

Bomedemstat for Blood Disorders

18+
All Sexes
Ann Arbor, MI

The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria: * Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat; * Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission. No hypothesis testing will be conducted in this study.

Phase 3
Recruiting

University of Michigan ( Site 6000) (+3 Sites)

Medical Director

Merck Sharp & Dohme LLC

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