← Back to Search

Other

CC-95251 for Leukemia

Phase 1

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

TN AML as defined by the 2016 WHO Classification, including secondary AML and therapy-related AML in participants who are ineligible (IE) for intensive chemotherapy (IC) and allogeneic hematopoietic stem cell transplant (HSCT)

R/R myelodysplastic syndromes (MDS) as defined by the 2016 WHO Classification with intermediate, high or very high risk by Revised International Prognostic Scoring System (IPSS-R)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 56 days after the last dose of study treatment

Awards & highlights

Study Summary

This trial is testing a new drug, CC-95251, to see if it is safe and works well against leukemia and certain types of cancer.

Who is the study for?

This trial is for adults with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), as well as treatment-naive MDS at higher risk. Participants should be able to perform daily activities with minimal assistance. They can't join if they have life-threatening complications, prior treatments with similar drugs, uncontrolled infections, recent cancer treatments, are on immunosuppressants, or are pregnant/nursing.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of CC-95251 alone and combined with other cancer drugs in treating AML and MDS. It's looking at how well patients respond to the treatment and what side effects occur when using CC-95251 with Azacitidine and Venetoclax.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system such as fever or chills, fatigue from anemia or low blood counts due to bone marrow suppression by Azacitidine/Venetoclax, bleeding issues from low platelets count, infection risks due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a type of leukemia that can't be treated with intense chemo or stem cell transplant.

Select...

My condition is a type of blood disorder classified as intermediate, high, or very high risk.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

My condition is relapsed or refractory acute myeloid leukemia.

Select...

My MDS is untreated and is intermediate, high, or very high risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 56 days after the last dose of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 56 days after the last dose of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 days after the last dose of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (AEs)

Number of participants with a Dose-limiting toxicity (DLT)

Secondary outcome measures

CRR for myelodysplastic syndromes (MDS) according to the modified International Working Group (IWG) Response Criteria

Complete remission rate (CRR) for acute myeloid leukemia (AML) according to the modified European Leukemia Net (ELN) response criteria

Duration of remission

+17 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: CC-95251 monotherapyExperimental Treatment1 Intervention

Group II: CC-95251 + azacitidine + venetoclaxExperimental Treatment1 Intervention

Group III: CC-95251 + azacitidineExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

Venetoclax

2019

Completed Phase 3

~1990

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,296 Total Patients Enrolled

Media Library

CC-95251 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05168202 — Phase 1

Myelodysplastic Syndrome Research Study Groups: CC-95251 monotherapy, CC-95251 + azacitidine, CC-95251 + azacitidine + venetoclax

Myelodysplastic Syndrome Clinical Trial 2023: CC-95251 Highlights & Side Effects. Trial Name: NCT05168202 — Phase 1

CC-95251 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05168202 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you provide information on any additional research projects that have utilized CC-95251?

"The initial research into CC-95251 occurred at Chinese University of Hong Kong-Prince of Wales Hospital in 2006. Since, there have been 160 completed studies with an additional 174 still ongoing, many situated within Miami, Florida."

Answered by AI

Is the recruitment process for this research open at present?

"Affirmative. Clinicaltrials.gov provides evidence that this experiment, which was first published on January 19th 2022, is enrolling participants as we speak. A total of 30 patients must be registered across 15 distinct healthcare sites."

Answered by AI

Has the drug CC-95251 been given the nod of approval by the Food and Drug Administration?

"Due to the limited evidence of safety and efficacy, CC-95251 was rated a 1 on our team's scale from 1 to 3."

Answered by AI

In what areas can this scientific experiment be accessed?

"This clinical trial is taking place at the University of Miami Hospital and Clinics, Sylvester Cancer Center in Miami, Florida; UT Southwestern-Harold C. Simmons Cancer Center in Dallas, Ontario; Local Institution in Toronto, Alberta; together with 15 other locations."

Answered by AI

What medical conditions generally warrant a prescription of CC-95251?

"The medication CC-95251 is used to treat cancerous tumours, as well as a host of other conditions including 20-30% blasts, neutropenia and/or thrombocytopenia, and anemia."

Answered by AI

What is the current enrollment count for this medical trial?

"The pharmaceutical giant, Bristol-Myers Squibb, must recruit 30 eligible patients to conduct the trial. There are 3 fixed locations - University of Miami Hospital and Clinics, Sylvester Cancer Center in Miami and UT Southwestern-Harold C. Simmons Cancer Center in Dallas – where they will be conducting this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes

2022. "A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05168202.

All > Acute Myeloid Leukemia > Myelodysplastic Syndrome