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Trial Title:
A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm
NCT ID:
NCT06597734
Condition:
Chronic Myelomonocytic Leukemia
Advanced Myeloproliferative Neoplasms
IDH1-mutated Higher-Risk Myelodysplastic Syndromes
Conditions: Official terms:
Leukemia
Neoplasms
Preleukemia
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndromes
Myeloproliferative Disorders
Syndrome
Azacitidine
Decitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Azacitidine (AZA)
Description:
Given by SC or IV
Arm group label:
Olutasidenib+Azacitidine-IV or SubQ
Intervention type:
Drug
Intervention name:
Decitabine
Description:
Given by IV
Arm group label:
Olutasidenib+Decitabine-IV
Arm group label:
Olutasidenib+Decitabine/Cedazuridine-PO
Intervention type:
Drug
Intervention name:
Olutasidenib
Description:
Given by PO
Arm group label:
Olutasidenib+Azacitidine-IV or SubQ
Arm group label:
Olutasidenib+Decitabine-IV
Arm group label:
Olutasidenib+Decitabine/Cedazuridine-PO
Intervention type:
Drug
Intervention name:
Cedazuridine
Description:
Given by PO
Arm group label:
Olutasidenib+Decitabine/Cedazuridine-PO
Summary:
To learn if olutasidenib, when combined with a drug called a hypomethylating agent (HMA)
can help to control MDS, CMML, and/or MPN. The safety of the drug combination will also
be studied.
Detailed description:
Primary Objectives To determine the overall response rate of olutasidenib in combination
with investigator's choice of HMA in patients with IDH1-mutated higher-risk MDS/CMML or
advanced MPN Secondary Objectives
The secondary objectives of this study are:
- To evaluate the rates of complete remission (CR) and median duration of CR
- To ascertain the safety and tolerability of olutasidenib with HMA in this
participant population
- To determine survival including overall survival (OS), progression-free survival
(PFS), and duration of response (DOR) To analyze reduction in IDH1 clone size
Exploratory Objectives
- To examine overall response rate of patients previously exposed to venetoclax
- To investigate global gene expression profiles, DNA methylation profiles, and other
potential prognostic markers to explore predictors of antitumor activity and/or
resistance to treatment
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pathologically proven higher-risk MDS/CMML or advanced MPN
1. MDS/CMML participants must have International Prognostic Scoring System (IPSS)
intermediate-2- or high-risk disease or Revised IPSS (IPSS-R) score > 3.5 or
Molecular IPSS (IPSS-M) moderate high-, high-, or very high-risk disease or
bone marrow blast percentage.
2. Advanced MPN is defined as bone marrow blast percentage >/=10%.
3. Participants on the treatment-naive arm must not have received a prior HMA.
Agents such as growth factors (e.g. erythropoietin stimulating agents,
luspatercept, eltrombopag, granulocyte colony stimulating factors),
cyclosporine, and/or hydroxyurea are allowed.
2. Participants must have a documented IDH1 mutation
3. Participants >/= 18 years old
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Appendix A)
5. Acceptable liver function
1. Bilirubin </= 2 times upper limit of normal (ULN) or </= 3 times ULN in
participants with Gilbert Syndrome
2. Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline
phosphatase </= 3 times ULN
6. Acceptable renal function with serum creatinine </= 1.5 times ULN or calculated
creatinine clearance >/= 50 mL/min (as assessed by Cockcroft-Gault, MDRD, or
CKD-Epi validated measures)
7. Negative serum or urine pregnancy test if female of childbearing potential
8. For fertile men and women, agreement to use highly effective contraceptive methods
for the duration of study participation and 90 days after the last dose of study
medication
9. Agreement for male participants not to donate sperm and for female participants of
childbearing potential not to donate ova during the study and for 90 days after the
final dose of study drug
10. Ability and willingness to sign informed consent prior to beginning study and
undergoing procedures
Exclusion Criteria:
1. Participants unable to swallow oral medications, or participants with
gastrointestinal conditions (e.g., malabsorption, resection, etc.) deemed by the
Investigator to jeopardize intestinal absorption
2. Participants with any concurrent uncontrolled clinically significant medical
condition, including life-threatening severe infection or psychiatric illness, which
could place the participant at unacceptable risk of study treatment
3. Known active hepatitis B (HBV) or hepatitis C (HCV) or HIV infection
4. Pregnant or nursing women or women of childbearing potential not using highly
effective contraception; male participants not using highly effective contraception
5. Participants with white blood cell count > 25 x109/L Note: hydroxyurea use is
permitted to meet this criterion
6. Unwillingness or inability to comply with procedures either required in this
protocol or considered standard of care
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Contact:
Last name:
Kelly Chien, MD
Phone:
713-745-7584
Email:
Kchien@mdanderson.org
Start date:
March 11, 2025
Completion date:
August 31, 2029
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
Rigel Pharmaceuticals
Agency class:
Industry
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06597734
https://www.mdanderson.org
