Description:
CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects
with relapsed or refractory acute myeloid leukemia and relapsed or refractory high-risk
myelodysplastic syndrome.
Title
- Brief Title: A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes
- Official Title: A Phase 1, Open-label, Dose Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes
Clinical Trial IDs
- ORG STUDY ID:
CC-90009-AML-001
- SECONDARY ID:
2017-001535-39
- NCT ID:
NCT02848001
Conditions
- Leukemia, Myeloid, Acute
- Myelodysplastic Syndromes
Interventions
Drug | Synonyms | Arms |
---|
CC-90009 | | CC-90009 - Part A |
Purpose
CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects
with relapsed or refractory acute myeloid leukemia and relapsed or refractory high-risk
myelodysplastic syndrome.
Detailed Description
Study CC-90009-AML-001 is an open-label, Phase 1, dose escalation and expansion,
first-in-human clinical study of CC-90009 in subjects with relapsed or refractory acute
myeloid leukemia (AML) and relapsed or refractory high-risk myelodysplastic syndrome.
The dose escalation part (Part A) of the study will evaluate the safety and tolerability of
escalating doses of CC-90009 in relapsed and refractory AML. The expansion part, (Part B),
will further evaluate the safety and efficacy of CC-90009 administered at or below the
maximum tolerated dose (MTD) in selected expansion cohorts of one or more dosing regimens in
order to determine the recommended Phase 2 dose (RP2D) for subjects with relapsed or
refractory AML and relapsed or refractory high-risk myelodysplastic syndrome.
Trial Arms
Name | Type | Description | Interventions |
---|
CC-90009 - Part A | Experimental | Will be administered intravenously per dosing schedule in a 28-day cycle. | |
CC-90009 - Part B - AML and MDS patients | Experimental | Relapsed or refractory AML and MDS subjects. IP will be administered intravenously per dosing schedule determined in Part A | |
Eligibility Criteria
Inclusion Criteria:
1. Men and women ≥ 18 years of age, at the time of signing the ICD (Informed Consent
Document).
2. Subject must understand and voluntarily sign an ICD prior to any study-related
assessments/procedures being conducted.
3. Relapsed or refractory AML (Acute Myeloid Leukemia) (Parts A and B) or relapsed or
refractory high-risk MDS (Myelodysplastic Syndrome) (Part B only) as defined by World
Health Organization criteria who are not suitable for other established therapies.
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
5. At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion (DLI)
without conditioning.
6. Subjects must have the following screening laboratory values:
- Total White Blood Cell count (WBC) < 25 x 109/L prior to first infusion. Prior or
concurrent treatment with hydroxyurea to achieve this level is allowed.
- Selected electrolytes within normal limits or correctable with supplements.
- Serum bilirubin ≤ 1.5 x ULN (upper limit of normal).
- Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault
equation.
7. Agree to follow the CC-90009 Pregnancy Prevention Plan (PPP)
Exclusion Criteria:
1. Subjects with acute promyelocytic leukemia (APL)
2. Subjects with clinical symptoms suggesting active central nervous system (CNS)
leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid is only required if
there is clinical suspicion of CNS involvement by leukemia during screening.
3. Patients with prior autologous hematopoietic stem cell transplant who, in the
investigator's judgment, have not fully recovered from the effects of the last
transplant (e.g., transplant related side effects).
4. Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or
reduced intensity conditioning ≤ 6 months prior to starting CC-90009.
5. Subjects on systemic immunosuppressive therapy post HSCT at the time of screening, or
with clinically significant graft-versus-host disease (GVHD). The use of topical
steroids for ongoing skin or ocular GVHD is permitted.
6. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives
or 4 weeks prior to starting CC-90009, whichever is shorter. Hydroxyurea is allowed to
control peripheral leukemia blasts.
7. Leukapheresis ≤ 2 weeks prior to starting CC-90009.
8. For Part B, previous SARS-CoV-2 infection within 10 days for mild or asymptomatic
infections or 20 days for severe/critical illness prior to C1D1.
9. For Part B, previous COVID-19 vaccine within 14 days of C1D1.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Dose- limiting toxicity (DLT) |
Time Frame: | Up to 42 days |
Safety Issue: | |
Description: | Number of participants with a DLT |
Secondary Outcome Measures
Measure: | Pharmacokinetics-Cmax |
Time Frame: | Up to Day 11 |
Safety Issue: | |
Description: | Maximum observed concentration in plasma |
Measure: | Pharmacokinetics - AUC24 |
Time Frame: | Up to Day 11 |
Safety Issue: | |
Description: | Area under the plasma concentration time-curve from time 0 to 24 hours |
Measure: | Pharmacokinetics - tmax |
Time Frame: | Up to Day 11 |
Safety Issue: | |
Description: | Time to peak (maximum) plasma concentration |
Measure: | Pharmacokinetics - t 1/2 |
Time Frame: | Up to Day 11 |
Safety Issue: | |
Description: | terminal half-life |
Measure: | Pharmacokinetics - CL |
Time Frame: | Up to Day 11 |
Safety Issue: | |
Description: | Total body clearance of the drug from plasma |
Measure: | Pharmacokinetics - Vss |
Time Frame: | Up to Day 11 |
Safety Issue: | |
Description: | Volume of distribution at steady-state |
Measure: | Preliminary efficacy of CC-90009 |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003) |
Measure: | Preliminary efficacy of CC-90009 - AML |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML. |
Measure: | Preliminary efficacy of CC-90009 - MDS |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | Determined by myelodysplastic syndrome (MDS) response rate based on the International Working Group (IWG) response criteria for Myelodysplasia. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Celgene |
Trial Keywords
- CC-90009
- Hematologic Cancers
- Leukemia
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- AML
- MDS
Last Updated
July 22, 2021