Health TrialsbyHealthPanel

MiRisten for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

ConditionsRecurrent Acute Myeloid LeukemiaRefractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

This phase I trial tests the safety, side effects, and best dose of miRisten in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). MiRisten may stop the growth of cancer cells by blocking some of the molecules needed for cell growth. Giving miRisten may be safe, tolerable and/or effective in treating patients with relapsed or refractory AML.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented informed consent of the participant and/or legally authorized representative.

Agreement to allow the use of archival tissue from diagnostic tumor biopsies

If unavailable, exceptions may be granted with study principal investigator (PI) approval.

≥ 18 years.

Disqualifiers

Allogeneic hematopoietic stem cell transplant within 3 months prior to day 1 of protocol therapy. Patients must be off calcineurin inhibitors for at least 2 weeks prior to day 1 of protocol therapy.

Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy, with the exception of hydroxyurea.

Strong and moderate CYP3A4 inducers and strong CYP3A inhibitors (with the exception of azole antifungals) within 7 days prior to day 1 of protocol therapy.

Foods/supplements that are strong inhibitors or strong or moderate inducers of CYP3A (such as St. John's wort) within 3 days prior to initiation of and during study treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo bone marrow and blood sample collection

  • Echocardiography Test

    Procedure/Surgery

    Undergo ECHO

  • miR-126 Inhibitor miRisten

    Drug

    Given IV

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Treatment (miRisten)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

Toxicity data collection will include incidence and nature of adverse events (AEs) (including grade 3 and 4 AEs, treatment-related AEs, serious adverse events, dose limiting and moderate toxicities, AEs requiring discontinuation of miRisten, and changes in laboratory values.

Time frame
Up to 30 days after completion of study treatment

Secondary outcomes

1

Disease response

Will be assessed according to the European LeukemiaNet Criteria.

Time frame
Up to 6 months after completion of study treatment
2

Duration of response

Will be estimated using the product-limit method of Kaplan and Meier.

Time frame
From the date of first documented response to documented disease relapse, progression or death whichever occurs first, assessed p to 6 months after completion of study treatment
3

Progression-free survival

Will be estimated using the product-limit method of Kaplan and Meier.

Time frame
From date of first dose of study drug to first documented evidence of disease progression or death from any cause, whichever occurs first, assessed up to 6 months after completion of study treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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