What side effects are associated with this type of intervention?

Common treatments for Myelodysplastic Syndrome (MDS) include hypomethylating agents such as azacitidine and decitabine. These agents can cause side effects like cytopenias (low blood cell counts), febrile neutropenia (fever with low white blood cell count), and gastrointestinal symptoms. Patients often require hospitalization for neutropenic fever. Erythropoiesis-stimulating agents (ESAs) and myeloid growth factors, used to manage anemia and neutropenia, can lead to bone pain, fevers, and an increased risk of thrombosis. Monitoring and dose adjustments are essential to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Myelodysplastic Syndrome (MDS), particularly hypomethylating agents (HMAs) such as azacitidine and decitabine. Azacitidine, administered either subcutaneously or intravenously, and decitabine, given intravenously, are both used to improve overall survival and hematologic response in MDS patients. Additionally, lenalidomide has been approved for MDS with deletion 5q cytogenetic abnormality. These treatments target specific pathways involved in the disease, similar to the novel therapeutic agent CC-90009 being studied for its efficacy in relapsed or refractory acute myeloid leukemia (AML) and higher-risk MDS.

What other types of research exist?

Promising novel alternatives to CC-90009 for Myelodysplastic Syndrome patients include LBH589, a histone deacetylase inhibitor, and BET bromodomain inhibitors like BI 894999. Both agents are in clinical trials and have shown activity in hematologic malignancies, including AML and MDS.

← Back to Search

BCL-2 Inhibitor

CC-90009 for Leukemia and Myelodysplastic Syndrome

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

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

Must have

At least 4 weeks has elapsed from donor lymphocyte infusion (DLI) without conditioning

Relapsed or refractory AML (Acute Myeloid Leukemia) or relapsed or refractory (R/R) higher-risk MDS (Myelodysplastic Syndrome) as defined by World Health Organization criteria who are not suitable for other established therapies

Must not have

Subjects with acute promyelocytic leukemia (APL)

Patients with prior autologous hematopoietic stem cell transplant who have not fully recovered from the effects of the last transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called CC-90009 in patients with certain blood cancers that have come back or didn't respond to treatment. The study aims to find the safest and most effective dose by adjusting the amount given to patients over time.

Who is the study for?

Adults with relapsed or refractory acute myeloid leukemia (AML) or higher-risk myelodysplastic syndrome (HR-MDS), who are not suitable for other therapies. Participants must have certain normal lab values, an ECOG Performance Status of 0-2, and cannot have had recent leukapheresis, CNS leukemia symptoms, significant graft-versus-host disease post-transplant, or recent cancer treatments.

What is being tested?

The study is testing different doses of a drug called CC-90009 to find the safest and most effective amount for treating AML and HR-MDS. It's an early-phase trial where all participants receive CC-90009; there's no comparison group receiving another treatment.

What are the potential side effects?

As this is a dose-finding study for CC-90009 in its early phase, specific side effects are being investigated. However, common side effects may include nausea, fatigue, blood count changes leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

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

Select...

It has been over 4 weeks since my last donor lymphocyte infusion without any prior preparation.

Select...

My AML or MDS has returned or didn't respond to treatment and I can't have standard therapies.

Select...

My kidneys are working well, with a creatinine clearance of 60 mL/min or more.

Select...

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

Select...

I am 18 years old or older and have signed the informed consent document.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with acute promyelocytic leukemia.

Select...

I had a stem cell transplant and haven't fully recovered yet.

Select...

I am on immune-suppressing drugs after a stem cell transplant or have significant graft-versus-host disease.

Select...

I had a stem cell transplant from a donor less than 6 months ago.

Select...

I had a leukapheresis procedure less than 2 weeks ago.

Select...

I have or might have leukemia in my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose- limiting toxicity (DLT)

Maximum tolerated dose (MTD)

Non-tolerated dose (NTD)

Secondary study objectives

Pharmacokinetics - AUC24

Pharmacokinetics - CL

Pharmacokinetics - Vss

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: CC-90009 - Part B - AML and MDS patientsExperimental Treatment1 Intervention

Relapsed or refractory AML and MDS subjects. IP will be administered intravenously per dosing schedule determined in Part A

Group II: CC-90009 - Part AExperimental Treatment1 Intervention

Will be administered intravenously per dosing schedule in a 28-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CC-90009

2020

Completed Phase 1

~10

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Myelodysplastic Syndrome (MDS) include erythropoiesis-stimulating agents (ESAs) that boost red blood cell production, thrombopoietin receptor agonists that increase platelet counts, and hypomethylating agents like azacitidine and decitabine that modify DNA methylation to restore normal cell function. Luspatercept, a newer agent, promotes late-stage erythropoiesis to reduce transfusion needs. These treatments are crucial for managing symptoms and improving quality of life in MDS patients. Novel agents like CC-90009, which target specific pathways in AML and MDS, offer hope for more effective and targeted therapies, potentially improving outcomes for patients with relapsed or refractory disease.

Lenalidomide as a disease-modifying agent in patients with del(5q) myelodysplastic syndromes: linking mechanism of action to clinical outcomes.