Relapsed Hematologic Malignancy study: Emavusertib vs Ibrutinib
Official title CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)
ClinicalTrials.gov ID: NCT03328078
What this study is testing
What is Emavusertib?
An investigational oral tablet being studied for relapsed or refractory hematologic malignancies.
Also referred to as CA-4948.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how safe the drug is, how it moves through the body, and whether it can fight cancer in people with relapsed or refractory primary central nervous system lymphoma.
- Who it's for
- Adults who have relapsed or refractory primary central nervous system lymphoma.
- What's involved
- Participants will take oral pills of emavusertib, sometimes together with ibrutinib, and will have regular clinic visits and medical tests to monitor safety and cancer response.
- Time commitment
- The study is divided into several parts with 28‑day treatment cycles; participants will need to attend scheduled visits throughout the study period.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Males and females greater than or equal to 18 years of age
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- Histopathologically confirmed diagnosis of PCNSL (medical record is acceptable).
- Participants with parenchymal lesions must have unequivocal evidence of disease progression (e.g., presence of at least 1 measurable target lesion [≥...
You likely can't join if
- for Part B and Part C
- Participants with only intraocular PCNSL without brain lesion or CSF involvement, T-cell lymphoma, systemic presence of lymphoma, or non-CNS lymphoma...
- Evidence of systemic lymphoma. This must be demonstrated by a positron emission tomography (PET) scan (or CT scan with contrast if applicable) of the...
- Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or...
- Active malignancy other than PCNSL requiring systemic therapy
- Previous BTKi treatment (Part C only).
See the full eligibility criteria
- Males and females greater than or equal to 18 years of age
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- Histopathologically confirmed diagnosis of PCNSL (medical record is acceptable). Cerebral biopsies are not required if imaging reveals typical images of PCNSL.
- Participants with parenchymal lesions must have unequivocal evidence of disease progression (e.g., presence of at least 1 measurable target lesion [≥ 10 millimeters (mm) and ≤ 40 mm in the longest diameter on brain...
- For participants limited to leptomeningeal involvement, cerebrospinal fluid (CSF) analysis (cytology and/or flow cytometry) with or without additional imaging (MRI) of the spine as clinically indicated is required to...
- for Part B and Part C
- Participants with only intraocular PCNSL without brain lesion or CSF involvement, T-cell lymphoma, systemic presence of lymphoma, or non-CNS lymphoma metastatic to the CNS
- Evidence of systemic lymphoma. This must be demonstrated by a positron emission tomography (PET) scan (or CT scan with contrast if applicable) of the chest, abdomen, and pelvis at Screening (testicular ultrasound may be...
- Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) or prior history of systemic lymphoma, unless the participant...
- Active malignancy other than PCNSL requiring systemic therapy
- Previous BTKi treatment (Part C only).
- History of Grade ≥ 3 rhabdomyolysis without complete recovery
- Requirement for urgent therapy due to uncontrolled tumor mass/edema effects.
- Received external beam radiation therapy to the CNS within 28 days prior to Cycle 1 Day 1.
- Received prior investigational drugs (including treatment in clinical research, unapproved combination products, and new dosage forms) within 28 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1
- Any prior systemic anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 14 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1 (with the exception of ibrutinib...
- Prior history of hypersensitivity or anaphylaxis to emavusertib, ibrutinib or any of their excipients.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Duarte, California, United States
- Santa Monica, California, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Omaha, Nebraska, United States
- Buffalo, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Prague, Czechia
- Bordeaux, France
- Marseille, France
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Duarte, California, United States; Santa Monica, California, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States and 27 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.