AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration
NCT ID: NCT04263181
Last Updated: 2025-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
80 participants
OBSERVATIONAL
2020-01-29
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 0
-A technical run-in of 5 patients with any of the following:
* Standard cytarabine/idarubicin induction, includes cytarabine 200 mg/m2 CIVI in 0.9% normal saline over 24 hours for 7 consecutive days (Days 1-7) \& idarubicin 12 mg/m2 per day for 3 consecutive days (Days 1-3). Other standard cytarabine-based induction protocols are allowed
* Decitabine 20 mg/m2/day as a 1-hour infusion on consecutive Days 1-5 or 1-10 of each 28-day cycle.
* Azacitidine 75 mg/m2/day as a subcutaneous injection on Days 1-7 or on day 1-5 and 8-9 of each 28-day cycle
* Decitabine 20 mg/m2/day as a 1-hour infusion on consecutive Days 1-5 or 1-10 of each 28-day cycle. Patients will receive venetoclax PO 100 mg on Day 1, 200 mg on Day 2, and 400 mg daily thereafter.
* Azacitidine 75 mg/m2/day as a 1-hour infusion or by subcutaneous injection on consecutive Days 1-7 or on day 1-5 and 8-9 of each 28-day cycle. Patients will receive venetoclax PO 100 mg on Day 1, 200 mg on Day 2, and 400 mg daily thereafter.
Peripheral blood draw
* All cohorts will have peripheral blood drawn at baseline no more than 4 days prior to the first dose of chemotherapy and must also occur before the first dose of chemotherapy
* Cohort 0 or 1 - peripheral blood draw on Day 2
* Cohorts 0, 2, 3, 4 and 5 - peripheral blood draw on Day 3
* Cohort 0 or 1 - peripheral blood draw on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - peripheral blood draw on Cycles 2 or 3 and 4 or 5, Day 28
Bone marrow aspirate
* Cohort 0 or 1 - bone marrow aspirate on Day 14
* Cohort 0 or 1 - bone marrow aspirate on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - bone marrow aspirate on Cycles 2 or 3 and 4 or 5, Day 28
Buccal swab
* Cohort 0 or 1 - buccal swab on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - buccal swab on Cycle 2 or 3 and 4 or 5, Day 28
Cohort 1
* Patients treated with cytarabine/idarubicin induction therapy
* Patients will receive a standard cytarabine/idarubicin induction, which includes cytarabine 200 mg/m2 CIVI in 0.9% normal saline over 24 hours for 7 consecutive days (Days 1-7) and idarubicin 12 mg/m2 per day in 0.9% normal saline over 15-30 minutes for 3 consecutive days (Days 1-3). Other standard cytarabine-based induction protocols are allowed (e.g. cytarabine/daunorubicin or Vyxeos).
Peripheral blood draw
* All cohorts will have peripheral blood drawn at baseline no more than 4 days prior to the first dose of chemotherapy and must also occur before the first dose of chemotherapy
* Cohort 0 or 1 - peripheral blood draw on Day 2
* Cohorts 0, 2, 3, 4 and 5 - peripheral blood draw on Day 3
* Cohort 0 or 1 - peripheral blood draw on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - peripheral blood draw on Cycles 2 or 3 and 4 or 5, Day 28
Bone marrow aspirate
* Cohort 0 or 1 - bone marrow aspirate on Day 14
* Cohort 0 or 1 - bone marrow aspirate on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - bone marrow aspirate on Cycles 2 or 3 and 4 or 5, Day 28
Buccal swab
* Cohort 0 or 1 - buccal swab on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - buccal swab on Cycle 2 or 3 and 4 or 5, Day 28
Cohort 2
* Patients treated with decitabine
* Patients will receive decitabine 20 mg/m2/day as a 1-hour infusion on consecutive Days 1-5 or 1-10 (per treating physician discretion) of each 28-day cycle.
Peripheral blood draw
* All cohorts will have peripheral blood drawn at baseline no more than 4 days prior to the first dose of chemotherapy and must also occur before the first dose of chemotherapy
* Cohort 0 or 1 - peripheral blood draw on Day 2
* Cohorts 0, 2, 3, 4 and 5 - peripheral blood draw on Day 3
* Cohort 0 or 1 - peripheral blood draw on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - peripheral blood draw on Cycles 2 or 3 and 4 or 5, Day 28
Bone marrow aspirate
* Cohort 0 or 1 - bone marrow aspirate on Day 14
* Cohort 0 or 1 - bone marrow aspirate on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - bone marrow aspirate on Cycles 2 or 3 and 4 or 5, Day 28
Buccal swab
* Cohort 0 or 1 - buccal swab on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - buccal swab on Cycle 2 or 3 and 4 or 5, Day 28
Cohort 3
* Patients treated with azacitidine
* Patients will receive azacitidine 75 mg/m2/day as a subcutaneous injection on Days 1-7 or on day 1-5 and 8-9 (per treating physician discretion) of each 28-day cycle
Peripheral blood draw
* All cohorts will have peripheral blood drawn at baseline no more than 4 days prior to the first dose of chemotherapy and must also occur before the first dose of chemotherapy
* Cohort 0 or 1 - peripheral blood draw on Day 2
* Cohorts 0, 2, 3, 4 and 5 - peripheral blood draw on Day 3
* Cohort 0 or 1 - peripheral blood draw on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - peripheral blood draw on Cycles 2 or 3 and 4 or 5, Day 28
Bone marrow aspirate
* Cohort 0 or 1 - bone marrow aspirate on Day 14
* Cohort 0 or 1 - bone marrow aspirate on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - bone marrow aspirate on Cycles 2 or 3 and 4 or 5, Day 28
Buccal swab
* Cohort 0 or 1 - buccal swab on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - buccal swab on Cycle 2 or 3 and 4 or 5, Day 28
Cohort 4
* Patients treated with decitabine + venetoclax
* Patients will receive decitabine 20 mg/m2/day as a 1-hour infusion on consecutive Days 1-5 or 1-10 (per treating physician discretion) of each 28-day cycle. Patients will receive venetoclax PO 100 mg on Day 1, 200 mg on Day 2, and 400 mg daily thereafter.
Peripheral blood draw
* All cohorts will have peripheral blood drawn at baseline no more than 4 days prior to the first dose of chemotherapy and must also occur before the first dose of chemotherapy
* Cohort 0 or 1 - peripheral blood draw on Day 2
* Cohorts 0, 2, 3, 4 and 5 - peripheral blood draw on Day 3
* Cohort 0 or 1 - peripheral blood draw on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - peripheral blood draw on Cycles 2 or 3 and 4 or 5, Day 28
Bone marrow aspirate
* Cohort 0 or 1 - bone marrow aspirate on Day 14
* Cohort 0 or 1 - bone marrow aspirate on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - bone marrow aspirate on Cycles 2 or 3 and 4 or 5, Day 28
Buccal swab
* Cohort 0 or 1 - buccal swab on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - buccal swab on Cycle 2 or 3 and 4 or 5, Day 28
Cohort 5
* Patients treated with azacitidine + venetoclax
* Patients will receive azacitidine 75 mg/m2/day as a 1-hour infusion or by subcutaneous injection on consecutive Days 1-7 or on day 1-5 and 8-9 (per treating physician discretion) of each 28-day cycle. Patients will receive venetoclax PO 100 mg on Day 1, 200 mg on Day 2, and 400 mg daily thereafter.
No interventions assigned to this group
Interventions
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Peripheral blood draw
* All cohorts will have peripheral blood drawn at baseline no more than 4 days prior to the first dose of chemotherapy and must also occur before the first dose of chemotherapy
* Cohort 0 or 1 - peripheral blood draw on Day 2
* Cohorts 0, 2, 3, 4 and 5 - peripheral blood draw on Day 3
* Cohort 0 or 1 - peripheral blood draw on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - peripheral blood draw on Cycles 2 or 3 and 4 or 5, Day 28
Bone marrow aspirate
* Cohort 0 or 1 - bone marrow aspirate on Day 14
* Cohort 0 or 1 - bone marrow aspirate on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - bone marrow aspirate on Cycles 2 or 3 and 4 or 5, Day 28
Buccal swab
* Cohort 0 or 1 - buccal swab on Day 35 (at count recovery)
* Cohorts 0, 2, 3, 4, and 5 - buccal swab on Cycle 2 or 3 and 4 or 5, Day 28
Eligibility Criteria
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Inclusion Criteria
* Peripheral blood blasts \> 1%
* Peripheral white blood cell count \> 1,000/µl.
* Age ≥ 18 years
* Anticipated treatment with any of the following regimens (Cohort 0) or:
* Cohort 1: A standard induction protocol with infusional cytarabine
* Cohort 2: Decitabine (either 5-day or 10-day regimens)
* Cohort 3: Azacitidine (either intravenous or subcutaneous administration)
* Cohort 4: Decitabine (either 5-day or 10-day) + venetoclax
* Cohort 5: Azacitidine (either intravenous or subcutaneous administration on 7 day or 5+2+2 schedule) + venetoclax
* Patients may receive these therapies as part of other on-going clinical trials or as standard of care treatment.
* Patients in Cohort 1 may receive SOC midostaurin or gemtuzumab ozogamicin, provided these start after the Day 2 sample is collected. Patients in Cohort 1 may receive a standard combination of cytarabine/idarubicin, cytarabine/daunorubicin, or Vyxeos, a liposomal formulation of cytarabine and daunorubicin.
* ECOG performance status ≤ 3
* Ability to understand and willingness to sign an IRB approved written informed consent document.
* Currently receiving any other investigational agents.
Exclusion Criteria
* Prior chemotherapy with hypomethylating agents
* Known history of positive HIV serology.
* Known positive Hepatitis C serology.
18 Years
ALL
No
Sponsors
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Notable Labs
INDUSTRY
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Meagan Jacoby, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201911201
Identifier Type: -
Identifier Source: org_study_id
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