8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia

StatusSuspended
PhasePhase 1
Started

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Record History

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  1. Recruitment suspended Sponsor's reason: Safety Issues, status is being updated per PI due to safety issues. Study is now Temporarily Closed to Accrual. Show 4 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description revised
    • Site details revised
  2. Start date: Dec 15, 2022 to Oct 31, 2022v11
  3. Trial status: Suspended to Recruiting
    • Site details revised
    v10
  4. Recruitment suspended Sponsor's reason: pending interim analysis
    • Site details revised
    v9
  5. Primary and study completion dates: Jan 25, 2027 to Jan 25, 2029v8
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Suspended to Recruiting
    • Site details revised
    v7
  2. Trial status: Recruiting to Suspended Sponsor's reason: pending drug
    • Site details revised
    v6
  3. Primary and study completion dates: Sep 24, 2023 to Jan 25, 2027
    • Start date: Jul 25, 2022 to Dec 15, 2022
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 31, 2022 to Jul 25, 2022
    • Site details revised
    v3
  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase I trial tests the safety, side effects, and best dose of a new 8-chloroadenosine in combination with venetoclax in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). 8-Chloroadenosine may help block the formation of growths that may become cancer. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving 8-chloroadenosine in combination with venetoclax may help prevent the disease from coming back in patients with acute myeloid leukemia.
Trial Details
NCT Number NCT05263284
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov