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Alkylating agents

Combination Therapy + Stem Cell Transplant for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Led By Guenther Koehne, MD. PhD
Research Sponsored by Guenther Koehne
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a Karnofsky (adult) Performance Status of at least 70%
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 and 24 months
Awards & highlights

Study Summary

This trial is testing a new combination therapy for high-risk FLT3 mutated AML patients who will also receive a stem cell transplant from a related or unrelated donor.

Who is the study for?
This trial is for adults with high-risk FLT3 mutated acute myeloid leukemia who are in good physical condition (able to perform daily activities without help) and have proper organ function. It's not for those who are pregnant, breastfeeding, have active infections, or HIV/HTLV viruses. People with leukemia in their brain/spinal cord can't join.Check my eligibility
What is being tested?
The study tests a combination of CPX-351 (a chemo drug) and midostaurin (FLT3-inhibitor) as initial treatment followed by a stem cell transplant that's been filtered to select CD34+ cells from a matching donor. The goal is to see how well this approach works for AML patients.See study design
What are the potential side effects?
Possible side effects include reactions related to the chemotherapy drugs like nausea, hair loss, mouth sores; immune system suppression leading to increased infection risk; and complications from the stem cell transplant such as graft-versus-host disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am able to care for myself but cannot do normal activities or work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12 and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Overall Survival (OS)
Change in Progression Free Survival (PFS)
Change in the complete remission rate
Secondary outcome measures
Change in the rate of Minimal Residual Disease (MRD) negativity
Correlation of Minimal Residual Disease (MRD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Investigational TreatmentExperimental Treatment6 Interventions
Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midostaurin
2018
Completed Phase 3
~1640
Busulfan
2008
Completed Phase 3
~1120
Melphalan
2008
Completed Phase 3
~1500
Fludarabine
2012
Completed Phase 3
~1100
CPX-351
2022
Completed Phase 3
~1090

Find a Location

Who is running the clinical trial?

Guenther KoehneLead Sponsor
2 Previous Clinical Trials
150 Total Patients Enrolled
Baptist Health South FloridaLead Sponsor
48 Previous Clinical Trials
7,811 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,265 Total Patients Enrolled

Media Library

Daunorubicin-cytarabine liposome (CPX-351) (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04982354 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Investigational Treatment
Acute Myeloid Leukemia Clinical Trial 2023: Daunorubicin-cytarabine liposome (CPX-351) Highlights & Side Effects. Trial Name: NCT04982354 — Phase 1 & 2
Daunorubicin-cytarabine liposome (CPX-351) (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04982354 — Phase 1 & 2

Frequently Asked Questions

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

Does the trial include geriatric patients?

"Subject to participation in this experiment are individuals aged 18 or higher, yet below 74 years of age."

Answered by AI

What is the estimated participant count for this clinical research?

"Absolutely. Per the information hosted on clinicaltrials.gov, this medical trial is seeking candidates to participate in its study and has been open since July 5th 2022. The most recent update was made 27 days later, with 20 participants currently being recruited from a single location."

Answered by AI

Is the study currently seeking participants?

"According to the official clinicaltrials.gov page, this research initiative is actively seeking participants after being initially posted on July 5th 2022 and recently updated as of July 27th 2022."

Answered by AI

Am I eligible to be part of this research endeavor?

"At present, this trial is recruiting 20 people with acute myeloid leukemia aged between 18 to 74. Those interested must meet the following prerequisites: a minimum Karnofsky Performance Status of 70%, and necessary organ functions for participation."

Answered by AI

What medical conditions have been known to respond favorably to CPX-351?

"CPX-351 is a widely used treatment for acute myelocytic leukemia, and can also be helpful in treating other ailments such as allogeneic hematopoietic stem cell transplantation, chronic myelogenous leukemias, systemic amyloidosis, essential thrombocythemia."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia
Guenther Koehne 2022. "Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04982354.
~13 spots leftby Aug 2031
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