Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies

NCT01260545 | Completed Phase 1

• 1 other identifier: 2010-PT015
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematologic Malignancies

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  One year

Study Arms (1)

Infusion

EXPERIMENTAL

A standard 3+3 design will be employed to determine maximum tolerated dose

Drug: CA-18C3

Interventions

CA-18C3 DRUG

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.

Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

bermekimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 15, 2010
• Study Start: April 30, 2011
• Primary Completion: June 30, 2012
• Study Completion: September 30, 2012
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

US (1)