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DNA Methyltransferase Inhibitor
Duvelisib + BMS-986345 for Lymphoma
Phase 1
Waitlist Available
Led By Hayder Saeed, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (corresponds to Karnofsky Performance Status [KPS] ≥ 80%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 and 12 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective when used with another cancer drug.
Who is the study for?
Adults with certain types of lymphoid malignancies, including various T-cell lymphomas and B-cell lymphomas, who have progressed after prior therapies. Participants must be over 18, have a performance status indicating they can carry out daily activities with little or no assistance, and not be pregnant or planning to conceive. They should also have adequate organ function.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dose of BMS-986345 when used in combination with duvelisib for treating specific lymphoid cancers. It aims to determine how well patients tolerate this drug combo.See study design
What are the potential side effects?
While the exact side effects are being studied, drugs like BMS-986345 and duvelisib may cause immune system reactions, infections due to lowered immunity, liver problems, diarrhea or other gastrointestinal issues, fatigue, rash or skin problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am fully active or can carry out light work.
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I have been diagnosed with a specific type of lymphoma or leukemia.
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I am 18 years old or older.
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I am fully active or have some restrictions but can still care for myself.
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My cancer is a type of lymphoid malignancy confirmed by tests.
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I have a tumor or enlarged lymph node larger than 1.5 cm.
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I have a specific type of T cell or NK cell cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Duration of Response
Overall Response
Overall Survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment2 Interventions
Dose escalation to determine the maximum tolerated dose (MTD) of BMS-986345 in combination with Duvelisib in patients with lymphoid malignancy. Patients will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 6 dose levels will be used.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duvelisib
2016
Completed Phase 3
~760
Find a Location
Who is running the clinical trial?
Secura Bio, Inc.Industry Sponsor
8 Previous Clinical Trials
234 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
547 Previous Clinical Trials
135,598 Total Patients Enrolled
Hayder Saeed, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
1 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I cannot take preventive treatments for pneumocystis or herpes viruses.I have been diagnosed with a specific type of lymphoma or leukemia.I am 18 years old or older.I haven't had major heart problems or a heart attack in the last 6 months.I am fully active or can carry out light work.I have mantle cell lymphoma and my condition worsened after two treatments.I have a specific type of lymphoma and have tried at least two treatments without success.I haven't had any cancer except for certain skin, bladder, prostate, or cervical cancers in the last 3 years.I had a stem cell transplant from a donor within the last 6 months or from myself within the last 3 months.I do not have any severe ongoing health issues affecting my kidneys, liver, blood, hormones, lungs, brain, or mental health.I have been treated for tuberculosis within the last 2 years.I am not taking, nor plan to take, any strong medications that affect drug metabolism during the study.I have a specific type of lymphoma and have tried at least one or two treatments without success.I haven't taken any cancer drugs or experimental medications recently.I am fully active or have some restrictions but can still care for myself.I have hepatitis B or C.I haven't fully recovered from major surgery complications before starting the study treatment.My side effects from previous treatments are mild or stable.I have not had a stroke or brain bleed in the last 6 months.I haven't had CART cell therapy in the last 90 days or have recovered from its side effects.I am experiencing symptoms of graft-versus-host disease.I am not currently undergoing any form of cancer treatment.I am currently taking high doses of steroids or other drugs that weaken my immune system.I do not have an ongoing infection needing strong medication or had a live vaccine recently.I am HIV positive.I cannot take pills by mouth due to my digestive system issues.My cancer is a type of lymphoid malignancy confirmed by tests.I have a tumor or enlarged lymph node larger than 1.5 cm.My organs and bone marrow are working well.I have heart failure or an irregular heartbeat that is not well-controlled.I have had lymphoma in my brain or spinal cord.I have a specific type of T cell or NK cell cancer.My organs and bone marrow are working well.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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