Hematologic MalignanciesPhase 1NCT01260545
Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies
A Phase 1 study testing CA-18C3 in people with Hematologic Malignancies, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to examine the safety and tolerability of CA-18C3 in subjects with hematologic malignancies, as well as look at the preliminary efficacy of IL-1alpha blockade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- CA-18C3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2011to 30 Sep 2012
- 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
- Male or female subjects age ≥ 18 years of age
- Subject must have a relapsed/refractory leukemia for which no standard therapies are anticipated to result in a durable remission. Subjects with previously treated high-risk myelodysplasia (MDS) (Intermediate 2 or high-risk by IPSS) and chronic myelomonocytic leukemia-2 (CMML-2 by WHO classification) are also candidates for this protocol. Relapsed/refractory leukemias include acute non-lymphocytic leukemia (AML) by WHO classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Subjects with myelofibrosis are also eligible. Untreated patients with above diagnoses considered unfit for standard therapy will also be eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Women of child bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Nursing subjects are excluded. Sexually active men must also use acceptable contraceptive methods for the duration of time on study. Pregnant and nursing subjects are excluded because the effects of CA-18C3 on a fetus or nursing child are unknown.
- In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for non-cytotoxic agents. If the subject is on hydroxyurea to control peripheral blood leukemic cell counts, the subject must be off hydroxyurea for at least ¬48 hours before initiation of treatment on this protocol. Persistent clinically significant toxicities from prior chemotherapy must not be greater than grade 1.
- Subjects must have the following clinical laboratory values (unless out of range values are considered to be the result of leukemic organ involvement):
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- Serum creatinine ≤ 2.0 mg/dl.
- Total bilirubin ≤ 1.5x the upper limit of normal unless considered due to Gilbert's syndrome.
- Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) ≤ 3x the upper limit of normal unless considered due to organ leukemic involvement.
- Signed and dated institutional review board (IRB)-approved informed consent before any protocol-specific screening procedures are performed.
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
- Subjects receiving any other standard or investigational treatment for their hematologic malignancy.
- Subjects who at the time of evaluation for participation in the study have evidence of active leukemic involvement in the brain or spinal cord (CNS).
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- Subjects immunocompromised due to a process unrelated to leukemic disease or treatment, including subjects known to be infected with human immunodeficiency virus (HIV)
- Subjects with detectable levels of endogenous antibodies to IL-1α at the time of screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies
The purpose of this study is to examine the safety and tolerability of CA-18C3 in subjects with hematologic malignancies, as well as look at the preliminary efficacy of IL-1alpha blockade.
- Conditions
- Hematologic Malignancies
- Being tested
- CA-18C3
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CA-18C3Drug
2.5 mg/kg, 3.75 mg/kg IV (in the vein) on Day 1 of each 14 day cycle until the subject is no longer benefiting clinically or unacceptable toxicity occurs.
| Study group | Role | What they receive |
|---|---|---|
| Infusion | Experimental | A standard 3+3 design will be employed to determine maximum tolerated dose Receives: Drug: CA-18C3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability of CA-18C3, as well as the pharmakokinetic properties of CA-18C3 in study participants.
To determine the toxicities, including the dose limiting toxicity and maximum tolerated dose of CA-18C3 when administered intravenously at up to 3.75 mg/kg twice monthly in subjects with hematologic malignancies.
To determine the pharmacokinetics (PK) of CA-18C3 following study drug administration
Measured: one year
Secondary outcomes (1)
Number of participants with disease progression, stable disease, partial response or complete response of their disease while receiving CA-18C3.
To observe the anti-tumor effects of CA-18C3, if any occur
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study start30 Apr 2011
- Primary completion30 Jun 2012
- Study completion30 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260545
- Sponsor's protocol ID
- 2010-PT015
- Status last verified
- Feb 2021
- First submitted
- 10 Dec 2010
- Last updated
- 16 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT01260545
- Acronym / sponsor ID
- 2010-PT015
- Conditions
- Hematologic Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2011 (actual)
- Primary completion
- 30 Jun 2012 (actual)
- Study completion
- 30 Sep 2012 (actual)
- First posted
- 15 Dec 2010 (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 examine the safety and tolerability of CA-18C3 in subjects with hematologic malignancies, as well as look at the preliminary efficacy of IL-1alpha blockade.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infusion | Experimental | Drug: CA-18C3A standard 3+3 design will be employed to determine maximum tolerated dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects age ≥ 18 years of age
- Subject must have a relapsed/refractory leukemia for which no standard therapies are anticipated to result in a durable remission. Subjects with previously treated high-risk myelodysplasia (MDS) (Intermediate 2 or high-risk by IPSS) and chronic myelomonocytic leukemia-2 (CMML-2 by WHO classification) are also candidates for this protocol. Relapsed/refractory leukemias include acute non-lymphocytic leukemia (AML) by WHO classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Subjects with myelofibrosis are also eligible. Untreated patients with above diagnoses considered unfit for standard therapy will also be eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Women of child bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Nursing subjects are excluded. Sexually active men must also use acceptable contraceptive methods for the duration of time on study. Pregnant and nursing subjects are excluded because the effects of CA-18C3 on a fetus or nursing child are unknown.
- In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for non-cytotoxic agents. If the subject is on hydroxyurea to control peripheral blood leukemic cell counts, the subject must be off hydroxyurea for at least ¬48 hours before initiation of treatment on this protocol. Persistent clinically significant toxicities from prior chemotherapy must not be greater than grade 1.
Key exclusion criteria (7 listed)
- Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
- Subjects receiving any other standard or investigational treatment for their hematologic malignancy.
- Subjects who at the time of evaluation for participation in the study have evidence of active leukemic involvement in the brain or spinal cord (CNS).
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
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 |
|---|---|---|
| CA-18C32.5 mg/kg, 3.75 mg/kg IV (in the vein) on Day 1 of each 14 day cycle until the subject is no longer benefiting clinically or unacceptable toxicity occurs. | Drug | Infusion |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability of CA-18C3, as well as the pharmakokinetic properties of CA-18C3 in study participants.
Time frame: one year
To determine the toxicities, including the dose limiting toxicity and maximum tolerated dose of CA-18C3 when administered intravenously at up to 3.75 mg/kg twice monthly in subjects with hematologic malignancies. To determine the pharmacokinetics (PK) of CA-18C3 following study drug administration
1 secondary outcome
Number of participants with disease progression, stable disease, partial response or complete response of their disease while receiving CA-18C3.
Time frame: One year
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 16 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CA-18C3 in people with Hematologic Malignancies, run by Janssen Research & Development, LLC at 1 site 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 10 inclusion and 7 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 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of participants with adverse events as a measure of safety and tolerability of CA-18C3, as well as the pharmakokinetic properties of CA-18C3 in study participants. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2021.