Melphalan for Myeloid Leukemia

M D Anderson Caner Center, Houston, TX
Myeloid Leukemia+3 More ConditionsMelphalan - Drug
Eligibility
18 - 70
All Sexes

Study Summary

This trial is testing the safety and effectiveness of adding a natural killer cell treatment to the standard stem cell transplant for leukemia patients.

Eligible Conditions
  • Myeloid Leukemia
  • Leukemia
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Similar Trials

1
Allogeneic Hematopoietic Stem Cell Transplantation
1
Treatment (TBI, IMRT)
1
Melphalan

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 100 days post-transplant

100 days post-transplant
Number of participants with Adverse Event Failure

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Allogeneic Hematopoietic Stem Cell Transplantation
1
Treatment (TBI, IMRT)
1
Melphalan

Side Effects for

Patients With Sickle Cell Anemia
36%Infection (grade 3 and above)
24%Graft versus host disease
8%Renal insufficiency
4%SupraVentricular Tachycardia
4%Alerted mental status
4%Posterior Reversible Encephalopathy Syndrome
4%Gastrointestinal bleed
4%Respiratory failure
4%Hypokalemia
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT01877837) in the Patients With Sickle Cell Anemia ARM group. Side effects include: Infection (grade 3 and above) with 36%, Graft versus host disease with 24%, Renal insufficiency with 8%, SupraVentricular Tachycardia with 4%, Alerted mental status with 4%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

8 Treatment Groups

Cyclophosphamide
1 of 8
Mesna
1 of 8
Total Body Irradiation One Dose
1 of 8
Filgrastim
1 of 8
Melphalan
1 of 8
Fludarabine phosphate
1 of 8
Mycophenolate mofetil
1 of 8
Tacrolimus
1 of 8

Experimental Treatment

24 Total Participants · 8 Treatment Groups

Primary Treatment: Melphalan · No Placebo Group · Phase 1 & 2

Cyclophosphamide
Drug
Experimental Group · 1 Intervention: Cyclophosphamide · Intervention Types: Drug
Mesna
Drug
Experimental Group · 1 Intervention: Mesna · Intervention Types: Drug
Total Body Irradiation One Dose
Drug
Experimental Group · 1 Intervention: Total Body Irradiation One Dose · Intervention Types: Drug
Filgrastim
Drug
Experimental Group · 1 Intervention: Filgrastim · Intervention Types: Drug
Melphalan
Drug
Experimental Group · 1 Intervention: Melphalan · Intervention Types: Drug
Fludarabine phosphate
Drug
Experimental Group · 1 Intervention: Fludarabine phosphate · Intervention Types: Drug
Mycophenolate mofetil
Drug
Experimental Group · 1 Intervention: Mycophenolate mofetil · Intervention Types: Drug
Tacrolimus
Drug
Experimental Group · 1 Intervention: Tacrolimus · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Coenzyme M
FDA approved
Cyclophosphamide
FDA approved
Mycophenolate mofetil
FDA approved
Filgrastim
FDA approved
Tacrolimus
FDA approved
Melphalan
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 100 days post-transplant

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,849 Previous Clinical Trials
1,793,500 Total Patients Enrolled
Jeremy Ramdial, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18 - 70 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Could you speak to any other research that has been conducted involving Melphalan?

"Currently, 1120 clinical trials investigating the use of Melphalan are underway with 208 in Phase 3. While some studies take place in Hamburg and Hessen, a total of 32017 sites across the globe offer this medication trial to patients." - Anonymous Online Contributor

Unverified Answer

Does the research team accept participants below forty years old?

"This study requires participants that are between 18 and 70 years old. There are 1116 trials available for minors, while seniors have access to 4322 similar clinical studies." - Anonymous Online Contributor

Unverified Answer

Are there any open slots for individuals to join this clinical experiment?

"Per the information on clinicaltrials.gov, this medical trial is still accepting participants. It was published to their website on April 8th 2022 and has been updated as recently as November 17th of the same year." - Anonymous Online Contributor

Unverified Answer

Am I eligible to participate in this research program?

"This clinical trial seeks 24 individuals aged 18 to 70 with a diagnosis of leukemia, and meeting the following criteria: body weight greater than 42 kgs; an HLA-matched related or unrelated donor (A, B, C antigens and DRB1); presence of one or more high risk features such as a preceding MDS diagnosis or complex/monosomal karyotype." - Anonymous Online Contributor

Unverified Answer

What is the scope of participant involvement in this research endeavor?

"Correct. According to the details present on clinicaltrials.gov, this research is currently recruiting participants; since it was initially posted on April 8th 2022 and updated most recently November 17th 2022. A total of 24 patients need to be enrolled from a single location." - Anonymous Online Contributor

Unverified Answer

What ailment is Melphalan usually prescribed for?

"Melphalan is a commonly-prescribed treatment for atopic dermatitis. It can also be employed to address acute myelocytic leukemia, multiple sclerosis, and psoriasis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top