RECRUITING

CC-486 and Venetoclax for Acute Myeloid Leukemia

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open label, dose escalation Phase I single institution pilot study for relapsed and refractory AML patients using CC-486 (oral azacitidine) with venetoclax. At the completion of dose escalation and after establishment of the MTD or recommended dose of CC-486 with venetoclax, an expansion phase will commence, using venetoclax with the MTD of CC-486 in relapsed/refractory patients.

Official Title

CC-486 and Venetoclax for Acute Myeloid Leukemia

Quick Facts

Study Start:2022-12-19

Study Completion:2029-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05287568

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject must have confirmation of non-APL AML by WHO criteria46 and have undergone at least one line of therapy (dose escalation and dose expansion cohorts). 2. Transplant eligible patients can participate in the study and they are allowed to proceed with stem cell transplantation at any time during the study. 3. Subject must have a projected life expectancy of at least 12 weeks. 4. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 2. 5. Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula. 6. Subject must have adequate liver function as demonstrated by: 1. aspartate aminotransferase (AST) ≤ 3.0 × ULN\* 2. alanine aminotransferase (ALT) ≤ 3.0 × ULN\* 3. bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome\* \* Unless considered due to leukemic organ involvement 7. Non-sterile male subjects must use contraceptive methods with partner(s) at least prior to beginning study drug administration and continuing up to 90 days after the last dose of study drug. Male subjects must agree to refrain from sperm donation from initial study drug administration until 90 days after the last dose of study drug. No contraception is required if male subjects are surgically sterile (vasectomy with medical assessment confirming surgical success) or if the male subject has a female partner who is postmenopausal or permanently sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). 8. Female subjects must be either: 1. Postmenopausal; defined as Age \> 60 years with no menses for 12 or more months without an alternative medical cause; OR 2. Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); OR 3. If subject is of childbearing potential, use of contraception is required while on study treatment and for 6 months after the last dose. 9. Subject must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any research directed screening or procedures. 10. Subject is informed that consumption of the following fruits is prohibited 3 days prior to the initiation of study treatment and throughout participation: grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit.	1. Subject has known active CNS involvement from AML. 2. Subject is known to be positive for HIV. HIV testing is not required. 3. Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load. Hepatitis B or C testing is not required and subjects with serologic evidence of prior vaccination to HBV (i.e., HBs Ag, anti-HBs+ and anti-HBc-) may participate. 4. Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to: 1. Significant active cardiac disease within the previous 6 months including: New York Heart Association heart failure \> class 2, unstable angina, or myocardial infarction. 2. Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia. 5. Subject has a malabsorption syndrome or other condition that precludes enteral route of administration. This includes history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease (e.g. sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity. 6. Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal). Uncontrolled is defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment. 7. Subject has a history of other malignancies prior to study entry, with the exception of: 1. Adequately treated in situ carcinoma of the breast or cervix uteri 2. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin 3. Prostate cancer not requiring therapy beyond hormonal therapy 4. Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent 8. Subject has a white blood cell count \> 25 × 109/L. Note: hydroxyurea or apheresis are permitted to meet this criterion. 9. Any subject who is a candidate for intensive induction therapy and agrees to receive this therapy. 10. Pregnant or breast-feeding females. A pregnancy test will be obtained at the time of screening. 11. Known or suspected hypersensitivity to azacitidine or mannitol.

Inclusion Criteria

Exclusion Criteria

1. Subject must have confirmation of non-APL AML by WHO criteria46 and have undergone at least one line of therapy (dose escalation and dose expansion cohorts).
2. Transplant eligible patients can participate in the study and they are allowed to proceed with stem cell transplantation at any time during the study.
3. Subject must have a projected life expectancy of at least 12 weeks.
4. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 2.
5. Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.
6. Subject must have adequate liver function as demonstrated by:
1. aspartate aminotransferase (AST) ≤ 3.0 × ULN\*
2. alanine aminotransferase (ALT) ≤ 3.0 × ULN\*
3. bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome\* \* Unless considered due to leukemic organ involvement
7. Non-sterile male subjects must use contraceptive methods with partner(s) at least prior to beginning study drug administration and continuing up to 90 days after the last dose of study drug. Male subjects must agree to refrain from sperm donation from initial study drug administration until 90 days after the last dose of study drug. No contraception is required if male subjects are surgically sterile (vasectomy with medical assessment confirming surgical success) or if the male subject has a female partner who is postmenopausal or permanently sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
8. Female subjects must be either:
1. Postmenopausal; defined as Age \> 60 years with no menses for 12 or more months without an alternative medical cause; OR
2. Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); OR
3. If subject is of childbearing potential, use of contraception is required while on study treatment and for 6 months after the last dose.
9. Subject must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any research directed screening or procedures.
10. Subject is informed that consumption of the following fruits is prohibited 3 days prior to the initiation of study treatment and throughout participation: grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit.

1. Subject has known active CNS involvement from AML.
2. Subject is known to be positive for HIV. HIV testing is not required.
3. Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load. Hepatitis B or C testing is not required and subjects with serologic evidence of prior vaccination to HBV (i.e., HBs Ag, anti-HBs+ and anti-HBc-) may participate.
4. Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:
1. Significant active cardiac disease within the previous 6 months including: New York Heart Association heart failure \> class 2, unstable angina, or myocardial infarction.
2. Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.
5. Subject has a malabsorption syndrome or other condition that precludes enteral route of administration. This includes history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease (e.g. sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity.
6. Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal). Uncontrolled is defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment.
7. Subject has a history of other malignancies prior to study entry, with the exception of:
1. Adequately treated in situ carcinoma of the breast or cervix uteri
2. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
3. Prostate cancer not requiring therapy beyond hormonal therapy
4. Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
8. Subject has a white blood cell count \> 25 × 109/L. Note: hydroxyurea or apheresis are permitted to meet this criterion.
9. Any subject who is a candidate for intensive induction therapy and agrees to receive this therapy.
10. Pregnant or breast-feeding females. A pregnancy test will be obtained at the time of screening.
11. Known or suspected hypersensitivity to azacitidine or mannitol.

Contacts and Locations

Study Contact

Derek Schatz

CONTACT

7208480628

derek.schatz@cuanschutz.edu

Principal Investigator

Daniel E Pollyea, MD

PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Study Locations (Sites)

CU Anschutz Medical Campus

Aurora, Colorado, 80045

United States

University of Colorado Hospital

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Daniel E Pollyea, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-19

Study Completion Date2029-03

Study Record Updates

Study Start Date2022-12-19

Study Completion Date2029-03

CC-486 and Venetoclax for Acute Myeloid Leukemia

Conditions

Quick Navigation

Study Overview

Description

Official Title

Quick Facts

Study ID

Participation Criteria

Contacts and Locations

Study Contact

Principal Investigator

Study Locations (Sites)

Collaborators and Investigators

Study Record Dates

Study Registration Dates

Study Record Updates

Terms related to this study

Additional Relevant MeSH Terms