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DSP107 + Azacitidine/Venetoclax for Leukemia
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have not been treated with drugs targeting CD47/SIRPα or immune boosters.I have not received a live vaccine in the last 4 weeks.I do not have any uncontrolled health conditions.I am not allergic to any of the materials or drugs used in the test.My AML or MDS/CMML has not improved after up to 2 treatments.I can take care of myself and am up and about more than 50% of my waking hours.I am experiencing symptoms of graft versus host disease.I do not have an active Hepatitis B or C infection.I have been diagnosed with acute promyelocytic leukemia.I stopped previous immunotherapy due to a severe reaction.I have a history of severe lung issues.I haven't had immunostimulatory treatment in the last 4 weeks.My leukemia is affecting my brain and causing symptoms.I have had an organ transplant and am on immunosuppressants.I had a severe reaction to previous immunotherapy.My liver is not working well and it affects my health significantly.My organs are working well.
- Group 1: DSP107 in combination with azacitidine or azacitidine plus venetoclax.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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