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DNA Methyltransferase Inhibitor

DSP107 + Azacitidine/Venetoclax for Leukemia

Phase 1
Recruiting
Research Sponsored by Kahr Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Relapsed/refractory AML or MDS/CMML patients who have failed up to 2 prior therapeutic regimens
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of treatment cycle 2 (within 2 months of treatment initiation)
Awards & highlights

Study Summary

This trial will enroll patients with relapsed/refractory AML or MDS/chronic myelomonocytic leukemia (CMML) who have failed up to 2 prior therapeutic regimens. Part A is a dose escalation study of a new drug, DSP107, given alone and with azacitidine. Part B is a dose escalation study of DSP107 given with azacitidine and venetoclax.

Who is the study for?
This trial is for patients with certain blood cancers like AML, MDS, or CMML who have tried and failed up to two treatments. They should have a white blood cell count under a specific limit, decent organ function, and be in fair to good physical condition (ECOG 0-2). It's not for those with severe liver disease, recent immunostimulatory treatment, active hepatitis B or C infection, lung issues, pregnancy/breastfeeding intentions during the study period.Check my eligibility
What is being tested?
The trial tests DSP107 combined with azacitidine (AZA) in Part A and adds venetoclax (VEN) in Part B. Both parts aim to find safe doses while checking how well these combinations work against the cancer by monitoring their effects on the body and cancer cells.See study design
What are the potential side effects?
Potential side effects of DSP107 include reactions related to immune system activation which could affect various organs. Azacitidine may cause nausea or low blood counts leading to fatigue or infections. Venetoclax can also lower blood counts and might lead to tiredness or bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My AML or MDS/CMML has not improved after up to 2 treatments.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of treatment cycle 2 (within 2 months of treatment initiation)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of treatment cycle 2 (within 2 months of treatment initiation) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events (AEs)
Dose Limiting Toxicities (DLT)
Response Rate (RR) including Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi)
Secondary outcome measures
4-week Mortality Rate
Change in Phenotypic and Activation Profiles of Peripheral Blood Mononuclear Cells
DSP107 Serum Concentration
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: DSP107 in combination with azacitidine or azacitidine plus venetoclax.Experimental Treatment3 Interventions
DSP107 will be administered by intravenous infusion once weekly during each 28-day cycle to all patients in this study. Azacitidine (75 mg/m2/day) will be administered subcutaneously or intravenously for the first 7 days of every cycle. Patients enrolled in Part B only will also receive venetoclax. During Cycle 1, venetoclax will be dose escalated daily to the goal dose of 400 mg daily. Patients will receive 100 mg on Day 1, 200 mg on Day 2 and 400 mg on Day 3 and onwards.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

Kahr MedicalLead Sponsor
2 Previous Clinical Trials
125 Total Patients Enrolled

Media Library

Azacitidine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04937166 — Phase 1
Acute Myeloid Leukemia Research Study Groups: DSP107 in combination with azacitidine or azacitidine plus venetoclax.
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04937166 — Phase 1
Azacitidine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04937166 — Phase 1

Frequently Asked Questions

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

Are people currently enrolled in this experiment?

"Affirmative. As per the information available on clinicaltrials.gov, this research study is currently recruiting participants who were first made aware of it on 13th January 2022 and was last edited on November 13th 2022. The trial requires a total of 36 volunteers to be enrolled at one site."

Answered by AI

What medical maladies is DSP107 regularly prescribed to address?

"The primary purpose of DSP107 is to administer induction chemotheraphy, yet it may also be employed to treat disorders such as refractory anemias, leukemia, myelocytic leukaemia, acute dysplasia and multilineage dysplasia."

Answered by AI

How have the risks of administering DSP107 been evaluated?

"DSP107 has only been tested in a limited capacity, thus Power rated its safety as 1 on the 3-point scale."

Answered by AI

Have any other research endeavors explored the effects of DSP107?

"340 trials that analyse the effects of DSP107 are currently in progress, with 54 of them having reached Phase 3. Most studies occur in Edmonton, Alberta but there are over 11 thousand locations conducting these tests around the world."

Answered by AI

What are the overarching goals of this research project?

"According to the primary sponsor, Kahr Medical, this trial's principal objective is to study Adverse Events (AEs) over a time-frame of 6 months post treatment. Additionally, secondary objectives such as 4-week Mortality Rate, Change in Phenotypic and Activation Profiles of Peripheral Blood Mononuclear Cells, and DSP107 Serum Concentration will also be assessed."

Answered by AI

To what extent is this research project engaging participants?

"Affirmative. The records on clinicaltrials.gov demonstrate that this medical experiment, initially uploaded on the 13th of January 2022, is currently enrolling participants. Out of 1 sites, 36 patients are required to join in order for it to move forward."

Answered by AI
~5 spots leftby Aug 2024