Acute Myelogenous LeukemiaPhase 1NCT02730312
PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies
A Phase 1 study testing XmAb14045 in people with Acute Myelogenous Leukemia and B-cell Acute Lymphoblastic Leukemia, run by Xencor, Inc. at 9 sites in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, B-cell Acute Lymphoblastic Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm
- What is being tested?
- XmAb14045
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2016to Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of 1 of the following diseases:
- Primary or secondary AML (including erythroleukemia and eosinophilic leukemia, but excluding acute promyelocytic leukemia)
- B-cell ALL
- BPDCN
- CML in blast phase, resistant or intolerant to tyrosine kinase inhibitor therapy
- Patients with relapsed or refractory disease with no available standard therapy
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- ECOG performance status 0-2
- Not a candidate for, or refusing treatment with hematopoietic stem cell transplantation
- Fertile patients must agree to use effective contraception during and for 4 weeks after the last dose of XmAb14045
- Male patients must agree to use highly effective contraception, and refrain from donating sperm during the treatment period and for at least 4 weeks after the last dose of XmAb14045
- Able and willing to complete the entire study
Who cannot join
- Systemic antineoplastic therapy (including cytotoxic chemotherapy and toxin immunoconjugates, but excluding hydroxyurea), unconjugated antibody therapy, or radiotherapy within 2 weeks of the first dose of study treatment, or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
- Prior therapy with CD123- or IL-3R-directed immunotherapies, including monospecific and bsAbs, immunoconjugates, or chimeric antigen receptor- modified T-cell therapy
- Failure to recover from Grade 3 or 4 toxicity from previous treatment (unrelated to malignant bone marrow involvement)
- Known uncontrolled central nervous system involvement by malignant disease
- Absolute blast count ≥10,000/mm3 or symptoms of leukostasis
- Diagnosis of promyelocytic leukemia
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- Aspartate aminotransferase or alanine aminotransferase at screening >3.0 x upper limit of normal (ULN) unless considered due to leukemic organ involvement
- Bilirubin >1.5 x ULN, unless prior diagnosis and documentation of leukemic organ involvement, ongoing hemolysis, or Gilbert's syndrome
- Serum creatinine >2.0 x ULN, or estimated creatinine clearance <40mL/min
- Active heart failure or New York Heart Association Class III or IV or Objective Assessment C or D
- History or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures, or completion
- Evidence of any active, uncontrolled bacterial, viral, parasitic, or systemic fungal infections within 1 week of first dose of study drug
- Positive test for human immunodeficiency virus (HIV) -I or -II antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody (unless HCV viral load test by PCR is negative). HBcAb positivity will be allowed if one or more of the following is true: a) HBsAb is present; b) hepatitis B DNA testing is negative and the patient is receiving hepatitis B reactivation prophylaxis with entecavir, tenofovir, or lamivudine
- Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the End of Study visit
- Patients with substance abuse or other medical or psychiatric conditions that, in the opinion of the Investigator, would confound study interpretation or affect the patient's ability to tolerate or complete the study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342
Northside Hospital
Atlanta, Georgia, 30342
The University of Chicago Medical Center
Chicago, Illinois, 60637
Wexner Medical Center at The Ohio State University
Columbus, Ohio, 43210
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Swedish Cancer Institute
Seattle, Washington, 98104
About this study
Official title: A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®14045 in Patients With CD123-Expressing Hematologic Malignancies
The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.
- Conditions
- Acute Myelogenous Leukemia, B-cell Acute Lymphoblastic Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm, Chronic Myeloid Leukemia, Blast Crisis
- Being tested
- XmAb14045
- Keywords
- AML, B-ALL, BPDCN, CML, Blast Crisis
- Medical subject headings
- Leukemia, Myeloid, Acute, Burkitt Lymphoma, Blastic Plasmacytoid Dendritic Cell Neoplasm, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Blast Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb14045Biological
Administered IV weekly up to 8 weeks, with or without step-up dosing
| Study group | Role | What they receive |
|---|---|---|
| XmAb14045 | Experimental | Biological/Vaccine: XmAb14045 Administered IV weekly up to 8 weeks Receives: Biological: XmAb14045 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as determined by the number of participants with treatment-related adverse events
Treatment-related adverse events as assessed by CTCAE v4.03
Measured: Baseline Day 1 through Day 56
Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing
Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing
Measured: Baseline Day 1 through Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Raman Garcha, MD, Study director, Xencor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730312
- Sponsor's protocol ID
- XmAb14045-01
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2016
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ravandi F, Bashey A, Foran J, Stock W, Mawad R, Short N, Yilmaz M, Kantarjian H, Odenike O, Patel A, Garcha R, Ainsworth WB, Clynes R, Kanodia J, Ding Y, Li H, Kye S, Mims A. Phase 1 study of vibecotamab identifies an optimized dose for treatment of relapsed/refractory acute myeloid leukemia. Blood Adv. 2023 Nov 14;7(21):6492-6505. doi: 10.1182/bloodadvances.2023010956.
PubMed 37647601
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®14045 in Patients With CD123-Expressing Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02730312
- Acronym / sponsor ID
- XmAb14045-01
- Conditions
- Acute Myelogenous Leukemia, B-cell Acute Lymphoblastic Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm, Chronic Myeloid Leukemia, Blast Crisis
- Keywords
- AML, B-ALL, BPDCN, CML, Blast Crisis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XmAb14045 | Experimental | Biological: XmAb14045Biological/Vaccine: XmAb14045 Administered IV weekly up to 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of 1 of the following diseases:
- Patients with relapsed or refractory disease with no available standard therapy
- ECOG performance status 0-2
- Not a candidate for, or refusing treatment with hematopoietic stem cell transplantation
- Fertile patients must agree to use effective contraception during and for 4 weeks after the last dose of XmAb14045
Key exclusion criteria (15 listed)
- Systemic antineoplastic therapy (including cytotoxic chemotherapy and toxin immunoconjugates, but excluding hydroxyurea), unconjugated antibody therapy, or radiotherapy within 2 weeks of the first dose of study treatment, or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
- Prior therapy with CD123- or IL-3R-directed immunotherapies, including monospecific and bsAbs, immunoconjugates, or chimeric antigen receptor- modified T-cell therapy
- Failure to recover from Grade 3 or 4 toxicity from previous treatment (unrelated to malignant bone marrow involvement)
- Known uncontrolled central nervous system involvement by malignant disease
- Absolute blast count ≥10,000/mm3 or symptoms of leukostasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XmAb14045Administered IV weekly up to 8 weeks, with or without step-up dosing | Biological | XmAb14045 |
Primary outcome
Safety as determined by the number of participants with treatment-related adverse events
Time frame: Baseline Day 1 through Day 56
Treatment-related adverse events as assessed by CTCAE v4.03
Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing
Time frame: Baseline Day 1 through Day 56
Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Derived from this study: PubMed 37647601Ravandi F, Bashey A, Foran J, Stock W, Mawad R, Short N, Yilmaz M, Kantarjian H, Odenike O, Patel A, Garcha R, Ainsworth WB, Clynes R, Kanodia J, Ding Y, Li H, Kye S, Mims A. Phase 1 study of vibecotamab identifies an optimized dose for treatment of relapsed/refractory acute myeloid leukemia. Blood Adv. 2023 Nov 14;7(21):6492-6505. doi: 10.1182/bloodadvances.2023010956.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raman Garcha, MD study director
Xencor, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XmAb14045 in people with Acute Myelogenous Leukemia and B-cell Acute Lymphoblastic Leukemia, run by Xencor, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as determined by the number of participants with treatment-related adverse events (time frame: Baseline Day 1 through Day 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02730312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.