Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113
NCT04070768
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
3176345842
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Ages 18 to 75 years at the time of consent.
- ECOG Performance Status of 0-2 within 7 days prior to registration.
- Patients must have AML, as defined,28 that is relapsed or refractory. Prior therapy including chemotherapy, immunotherapy, biological or targeted therapy (e.g. FMS-like tyrosine kinase-3 (FLT3) inhibitors, other kinase inhibitors, azacitidine, ATRA) is allowed.
- CD33 expression by flow cytometry, assessed as CD33 expression in at least 20% of the leukemia blasts per local pathologist.29
- Prior cancer treatment must be completed at least 21 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤Grade 1 or baseline.
- Demonstrate adequate organ function as defined in the protocol.
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
- Females of childbearing potential and males must be willing to use effective contraception during treatment and for at least 30 days after the last dose of Venetoclax. Females will be advised to use effective contraception for at least 6 months after the last dose of Gemtuzumab and males for at least 3 months after the last dose of Gemtuzumab.
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
- Patients with history of prior use of GO or Venetoclax
- History of myeloproliferative neoplasm [MPN] including myelofibrosis, essential
thrombocythemia, polycythemia vera, CML with or without BCR-ABL1 translocation, and
AML with BCR-ABL1 translocation.
- More than two lines of prior therapy.
- WBC >25 × 109/L. Cytoreduction is required (hydroxyurea as per local standard of
care).
- Acute promyelocytic leukemia.
- Unresolved ≥grade 2 clinically significant nonhematologic toxicities from prior
anticancer therapy or unresolved disseminated intravascular coagulation ≥ grade 2 per
CTCAE v5 criteria.
- History of other malignancies within 1 year prior to study entry, with the exception
of: adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of
breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the
skin; previous malignancy confined and surgically resected (or treated with other
modalities), with curative intent.
- Investigational drug within 4 weeks of study entry.
- History of CHF requiring treatment, left ventricular ejection fraction ≤ 50%, cardiac
insufficiency grade III or IV per New York Heart Association classification (NYHA), or
chronic stable angina.
- Patients who are HIV positive.
- Known CNS involvement with AML.
- Previous hematopoietic stem cell transplant within 2 months.
- Previous history of veno-occlusive disease/sinusoidal obstruction syndrome.
- Patients who are positive for hepatitis B or C infection with the exception of those
with an undetectable viral load within 3 months. Subjects with serologic evidence of
prior vaccination to HBV [i.e., HBs Ag-, and anti-HBs+] may participate.
- Active uncontrolled infection or severe systemic infection. Enrollment is possible
after control of infection, at discretion of the treating physician.
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the
mother is being treated on study).
- Patients who have received strong and/or moderate CYP3A inducers or inhibitors within
7 days prior to the initiation of study treatment. (See Appendix III)
- Patients who have consumed grapefruit, grapefruit products, Seville oranges (including
marmalade containing Seville oranges) or Starfruit within 3 days prior to the
initiation of study treatment.
- Malabsorption syndrome or other condition that precludes enteral route of
administration.
- Psychological, familial, sociological, or geographical condition that would preclude
study compliance and follow-up.
- Unable or unwilling to undergo a screening bone marrow study.
- Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the patient
inappropriate for enrollment in this study.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- New York, New York
- Dresden,
- Frankfurt am Main,
- Heidelberg,
- Jena,
- Kiel,
- Leipzig,
- Mannheim,
- Münster,
- Nürnberg,
- Ann Arbor, Michigan
- Omaha, Nebraska
- Chicago, Illinois
- Indianapolis, Indiana
- Hershey, Pennsylvania
Descriptive Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
Brief Title ICMJE | Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113 | ||||||||
Official Title ICMJE | Phase Ib Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113 | ||||||||
Brief Summary | This is a Phase Ib Study to determine the Maximum Tolerated Dose (MTD) of Venetoclax in combination with Gemtuzumab Ozogamicin(GO) in subjects with relapsed/refractory acute myeloid leukemia. Using a standard 3+3 design, subjects will receive once cycle of combination therapy. After one cycle of combination therapy, subjects showing response will continue on to one cycle of consolidation therapy with GO\Veneoclax. Subjects who respond to combination therapy will continue on maintenance Venetoclax until progression or unacceptable toxicity. Dose-limiting toxicity, defined as an adverse event related (possible, probably, or definite) to Venetoclax and/or Gemtuzumab fulfilling one of the following criteria:
The study will also evaluate the Overall Response Rate, Anti-leukemic activity, Relapse-free Survival (RFS), event-free survival (EFS) , and overall survival (OS). The study will evaluate quality of life using the European Organization for the Research and Treatment of Cancer 30 item questionnaire (EORTC QLQ-C30). | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||
Condition ICMJE | Acute Myeloid Leukemia | ||||||||
Intervention ICMJE |
| ||||||||
Study Arms ICMJE | Experimental: Gemtuzumab Ozogamicin(GO) + Venetoclax
Gemtuzumab Ozogamicin(GO) + Venetoclax Interventions:
| ||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 24 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | October 2022 | ||||||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||||
Sex/Gender ICMJE |
| ||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
| ||||||||
Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04070768 | ||||||||
Other Study ID Numbers ICMJE | BTCRC-AML17-113 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
| ||||||||
IPD Sharing Statement ICMJE |
| ||||||||
Responsible Party | John Quigley, Big Ten Cancer Research Consortium | ||||||||
Study Sponsor ICMJE | John Quigley | ||||||||
Collaborators ICMJE |
| ||||||||
Investigators ICMJE |
| ||||||||
PRS Account | Big Ten Cancer Research Consortium | ||||||||
Verification Date | November 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |