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New treatment option for Hematologic Neoplasms
Official title A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies
ClinicalTrials.gov ID: NCT07572006
What this study is testing
What is JNJ-95804306?
JNJ-95804306 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hematologic neoplasms.
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 purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose [RP2D]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone and/or when administered in addition to standard of care (SoC) therapy at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system).
- Phase 1: an early, usually small safety study
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
- For Arm A:
- Have a diagnosis of: Acute myeloid leukemia (AML) per International Consensus Classification (ICC) 2022 or myelodysplastic syndromes (MDS) per world...
- Body weight greater than or equal to (\>=) 40 kilograms (kg)
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2 For Arm B:
- Have a diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) that meets International workshop on chronic lymphocytic...
You likely can't join if
- For Arm A:
- Has acute promyelocytic leukemia according to world health organization (WHO) 2016 criteria or known active central nervous system (CNS) involvement...
- Need for supplemental oxygen use to maintain adequate oxygenation
- Have evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
- For US sites: Has acute promyelocytic leukemia according to WHO 2016 criteria or known active CNS involvement of AML/MDS For Arm B:
- Need for supplemental oxygen use to maintain adequate oxygenation
See the full eligibility criteria
- For Arm A:
- Have a diagnosis of: Acute myeloid leukemia (AML) per International Consensus Classification (ICC) 2022 or myelodysplastic syndromes (MDS) per world health organization (WHO) 2022 classified as moderate high, high, or...
- Body weight greater than or equal to (\>=) 40 kilograms (kg)
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2 For Arm B:
- Have a diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) that meets International workshop on chronic lymphocytic leukemia (iwCLL), National cancer institute (NCI) Working Group...
- Body weight \>= 40 kg
- ECOG performance status of 0 to 2
- Have clinically measurable disease
- For US sites: Have a diagnosis of CLL/SLL that meets iwCLL, NCI Working Group Guidelines which is relapsed or refractory and requires treatment with no other approved therapies available that would be more appropriate...
- For Arm A:
- Has acute promyelocytic leukemia according to world health organization (WHO) 2016 criteria or known active central nervous system (CNS) involvement of AML/MDS, unless in specific cohort (s) per study evaluation team...
- Need for supplemental oxygen use to maintain adequate oxygenation
- Have evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
- For US sites: Has acute promyelocytic leukemia according to WHO 2016 criteria or known active CNS involvement of AML/MDS For Arm B:
- Need for supplemental oxygen use to maintain adequate oxygenation
- Have evidence of uncontrolled systemic viral, bacterial, or fungal infection requiring initiation of parenteral treatment as medical intervention
- Developed Richter's transformation or prolymphocytic leukemia
- Known active CNS or leptomeningeal involvement of CLL/SLL
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Grand Rapids, Michigan, United States
- Piscataway, New Jersey, United States
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 - 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?
Study sites include Indianapolis, Indiana, United States; Grand Rapids, Michigan, United States; Piscataway, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.