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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients in the Phase 2 dose-expansion portion must have a confirmed diagnosis of relapsed or refractory AML, as determined by pathology review at the treating institution, and who failed available standard therapies known to be active for their AML. They must also have a documented KMT2A (MLL)-fusion or NPM1 mutation, which includes those with coexisting FLT3 genomic alterations and/or IDH1/2 mutations.
Females of childbearing potential must have a negative serum pregnancy test. Females of childbearing potential are defined as women who have (1) experienced menarche and have not undergone sterilization procedures (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or have (2) not experienced menopause (defined as having amenorrhea continuously for more than 12 months that is not determined to be drug-induced, or who are taking hormone replacement therapy with serum follicle-stimulating hormone > 35 mlU/ml).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 months after first dose
Awards & highlights
Study Summary
This trial is testing a new drug for people with a certain type of blood cancer who have not responded to other treatments.
Who is the study for?
This trial is for adults with relapsed or refractory Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL), who have failed standard treatments. Phase 1 includes those with certain genetic abnormalities, while Phase 2 requires a confirmed diagnosis of AML with specific mutations. Participants must be in good physical condition, not pregnant, and willing to use effective contraception.Check my eligibility
What is being tested?
The study tests DSP-5336, a new drug for patients whose leukemia has returned after treatment or hasn't responded to previous therapies. It's conducted in two parts: first determining the right dose and then expanding that dose to more patients with particular genetic markers.See study design
What are the potential side effects?
While the side effects of DSP-5336 are not explicitly listed here, similar drugs may cause nausea, fatigue, increased risk of infection due to low blood cell counts, liver issues, and potential allergic reactions among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have AML that didn't respond to treatment and have specific genetic changes.
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I am a woman who can have children and have a negative pregnancy test.
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I can do most of my daily activities without help.
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I am over 18 years old, or over 20 if my local laws require it.
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My kidneys are functioning well, with a creatinine clearance rate of 50 ml/min or higher.
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My leukemia cells can be tested for genetic changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 months after first dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 months after first dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 2 To evaluate clinical activity of DSP-5336 in adult patients with Relapsed /refractory AML who have MLL (KRMa gene rearrangement or NPM1 gene mutation)
Phase I Assess the safety and tolerability of DSP-5336 in relapsed/refractory AML, ALL or acute leukemia of amibiguous lineage
Phase I Determine the RP2D based on lowest dose of DSP-5336 that provides the maximum biologic and clinical effect, or the MTD, whichever is lower.
Secondary outcome measures
2. Phase 2 To further assess safety and tolerability of DSP-5336 in adult patients with Relapsed /refractory AML
Phase I Preliminary clinical activity of DSP-5336 in adult patients with AML or ALL
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2 Arm B: AML with NPM1c mutationsExperimental Treatment1 Intervention
Patients with R/R AML w/ NPM1c mutations
Group II: Phase 2 Arm A AML with MLL (KMT2A) gene rearrangementsExperimental Treatment1 Intervention
Patients with R/R AML w/MLL (KMT2A) gene rearrangements
Group III: Phase 1 Arm B with AntifungalsExperimental Treatment1 Intervention
Patients receiving anti-fungals that are moderate to strong cytochrome CYP3A4/5 inhibitors (i.e. Posaconazole, voriconazole, fluconazole, or isavuconazonium (prodrug of isavuconazole).
Group IV: Phase 1 Arm A without AntifungalsExperimental Treatment1 Intervention
Patients not taking antifungals within 7 days of study entry
Find a Location
Who is running the clinical trial?
Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,650 Total Patients Enrolled
Sumitomo Dainippon Pharma Oncology, IncLead Sponsor
41 Previous Clinical Trials
6,558 Total Patients Enrolled
Sumitomo Pharma Oncology, Inc.Lead Sponsor
44 Previous Clinical Trials
6,879 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My leukemia is causing severe or life-threatening issues.I haven't taken cancer drugs, except for hormone therapy or hydroxyurea, in the last 14 days.I recently had a donor lymphocyte infusion or am on immunosuppressive therapy after a stem cell transplant.I am not taking strong drugs that affect liver enzymes, except for some antifungals.My heart's pumping ability is below normal.I have AML that didn't respond to treatment and have specific genetic changes.I cannot take pills due to severe swallowing or digestion issues.I do not have an active infection, including HIV, HBV, or HCV.I am a woman who can have children and have a negative pregnancy test.I have not had major surgery in the last 4 weeks.My leukemia has spread to my brain or spinal cord.I can do most of my daily activities without help.I am over 18 years old, or over 20 if my local laws require it.My white blood cell count is below 30,000/μL.My side effects from previous treatments are mild, except for possible hair loss or nerve pain.I have received high doses of anthracycline, but my doctor believes it's safe for me.My kidneys are functioning well, with a creatinine clearance rate of 50 ml/min or higher.I have a history of lung disease (Japan only).I have not taken calcineurin inhibitors in the last 4 weeks.My leukemia cells can be tested for genetic changes.I have an ongoing serious infection needing treatment.I have another type of cancer that is spreading and not under control.I have had Torsades de Pointes in the past.I have been treated with menin-MLL inhibitors before.I have not had immunotherapy or cancer vaccines in the last 42 days.I had a stem cell transplant or CAR-T therapy within the last 2 months.My liver disease is severe (Child-Pugh Class B or worse).I am on medication for an autoimmune disease, but not high-dose steroids or azathioprine.I have relapsed or refractory acute leukemia and standard treatments have failed.I have been diagnosed with acute promyelocytic leukemia.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Arm A without Antifungals
- Group 2: Phase 1 Arm B with Antifungals
- Group 3: Phase 2 Arm A AML with MLL (KMT2A) gene rearrangements
- Group 4: Phase 2 Arm B: AML with NPM1c mutations
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this research accessible in multiple locations?
"This medical trial is currently enrolling patients in 6 sites, spread across New york, Chapel Hill and Houston plus an additional 3 locales. If you choose to be involved, it would be prudent to select the closest location so as to minimize your travelling needs."
Answered by AI
Are researchers still seeking participants for this trial?
"As outlined on clinicaltrials.gov, enrollment for this medical trial is ongoing and began in February 28th 2022. The last update to the information was posted November 18th 2022."
Answered by AI
What is the enrollment limit of this medical experiment?
"Affirmative. Clinicaltrials.gov lists this clinical trial as being open to recruitment, with the initial posting on February 28th 2022 and last update occurring November 18th 2022. 70 test subjects are necessary across 6 different sites for completion of said study."
Answered by AI
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