Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant
Pilot Trial of Olutasidenib Maintenance Post Allogeneic Hematopoietic Cell Transplantation in Patients Carrying IDH1 Mutation With AML, MDS, or CMML Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 years
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Mutant (m)IDH1 testing on peripheral blood samples with standard polymerase chain reaction (PCR)."
- "Patients also undergo blood sample collection on study."
- "After completion of study treatment, patients are followed up at 30 days and then up to 2 years."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety and side effects of olutasidenib and whether it can help keep cancer from coming back after a donor blood stem cell transplant. It is for adults with AML, MDS, or CMML—blood or bone marrow cancers—with a change in the IDH1 gene.
This phase I trial tests the safety, side effects, and effectiveness of olutasidenib in preventing the return of disease (relapse) in patients who have undergone donor (allogeneic) hematopoietic cell transplant for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML) carrying an IDH1 mutation. Olutasidenib is in a class of medications called IDH1 inhibitors. It works by slowing or stopping the growth of cancer cells. Giving olutasidenib may be safe, tolerable and/or effective in preventing relapse in patients with IDH1 mutated AML, MDS or CMML after an allogeneic hematopoietic cell transplant.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and able to do most daily activities.
- Have AML, MDS, or CMML with an IDH1 gene change. If the disease came back before transplant, this gene change must still be present.
- Be planning to have, or have already had, a donor blood stem cell transplant. Past treatment with IDH1-blocking drugs is allowed.
- At day 30 after transplant, have fewer than 5% immature cells called blasts in the bone marrow. Small amounts of disease found by sensitive tests are allowed.
- Meet blood count requirements. Some people with low counts may qualify if they are being treated for certain infections.
- Meet liver, kidney, heart rhythm, and infection test requirements before treatment.
- If able to become pregnant, have a negative pregnancy test. People who can have children must use effective birth control or avoid sex that could cause pregnancy during treatment and for at least 3 months afterward.
- Give written consent and allow use of stored tissue from earlier tumor tests. The study leader may allow an exception if tissue is not available.
Who can't join
- Have had more than one donor blood stem cell transplant, or an allergic reaction to a drug similar to olutasidenib.
- Have serious ongoing diarrhea that could make taking the drug by mouth difficult.
- Have a serious uncontrolled illness or an uncontrolled infection needing medicines that treat the whole body. Infections controlled with treatment are allowed.
- Have active hepatitis B, hepatitis C, or HIV, or a detectable amount of HIV in the blood within the past 6 months.
- Have another active cancer. Exceptions include certain skin cancers and early cervical cancer. A past cancer may be allowed if treatment aimed to cure it and it has been in complete remission for more than 2 years.
- Be pregnant or breastfeeding.
- Have certain active graft-versus-host disease (GVHD), when donor cells attack the body. This includes moderate to severe sudden GVHD, certain steroid treatment needs, or liver test problems caused by active GVHD. Some mild cases are allowed.
- Have another condition that the study doctor believes makes participation unsafe, or be unable to follow study procedures.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky performance status (KPS) ≥ 70 * Patients who are scheduled to receive or have already undergone allogeneic hematopoietic cell transplantation (alloHCT) from any donor type, any conditioning regimen, and regardless of GVHD prophylaxis will be include * Patients must have AML, MDS, or CMML with mIDH1 diagnosis at diagnosis (regardless of time from HCT). Note: Patient with pre-HCT disease relapse will no be included if mIDH1 is not detected after relapse * Day 30 marrow post alloHCT should show evidence of morphologic remission with \< 5% bone marrow (BM) blasts. Patients with MRD-positive status either by flow cytometry or IDH1 mutation testing will be eligible * Patients with previous therapy with IDH1 inhibitors will be included * Absolute neutrophil count (ANC) \> 1000/mm\^3 (within 28 days prior to day 1 of protocol) * Hemoglobin ≥ 8.0 gm/dL (within 28 days prior to day 1 of protocol) * Platelets ≥ 50,000/mm\^3 (within 28 days prior to day 1 of protocol) Note: Patients with lower counts can enroll if infection cytomegalovirus (CMV)/human herpes virus 6 (HHV6), etc. is being treated actively * Bilirubin ≤ 2 x upper limit of normal (ULN) (within 28 days prior to day 1 of protocol) (unless has Gilbert's disease). Patients with abnormal liver function tests (LFTs) due to active GVHD will not be eligible * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2 x ULN (within 28 days prior to day 1 of protocol). Patients with abnormal LFTs due to active GVHD will not be eligible * Creatinine clearance of ≥ 30/min/1.73 m\^2 for participants with creatinine levels above institutional normal per 24 hour urine test or the Cockcroft-Gault formula (within 28 days prior to day 1 of protocol) * Corrected QT interval (QTc) ≤ 480 ms (Note: To be performed within 28 days prior to day 1 of protocol therapy) * Seronegative for HIV antigen/antibody (Ag/Ab) combo, hepatitis C virus (HCV) (if positive, hepatitis C ribonucleic acid \[RNA\] quantitation must be performed), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \[RPR\]) (within 28 days prior to day 1 of protocol) * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 28 days prior to day 1 of protocol). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Agreement by females and males of childbearing potential, defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only), to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy Exclusion Criteria: * Patients with more than one allogeneic HCT * History of allergic reactions attributed to compounds of similar chemical or biological composition to study agent * Active diarrhea considered clinically significant and may impair oral drug administration * Clinically significant uncontrolled illness * Uncontrolled infection requiring systemic antimicrobials * Active infection: Patients with treated viral, bacterial or fungal infections that are controlled on therapy will be allowed to participate * Participant has detectable human immunodeficiency virus (HIV) viral load within the previous 6 months (must have viral load testing prior to study enrollment if participant has a known history of HIV 1/2 antibodies) * Active hepatitis B or C, or HIV * Other active malignancy. Participants with history of prior malignancy treated with curative intent who achieved CR more than 2 years before study entry are eligible. This exclusion rule does not apply to non-melanoma skin tumors and in-situ cervical cancer * Females only: Pregnant or breastfeeding * Active grade II-IV acute GVHD per Mount Sinai Acute Graft Versus Host Disease International Consortium (MAGIC) criteria and/or requiring systemic steroids with prednisone dose equivalent of ≥ 0.25 mg/kg at end of 4 weeks. Patients with a mild form of acute GVHD involving skin, gut or liver requiring topical steroid creams or oral beclomethasone (8 mg/day), entocort, (9 mg/day) and/or solumedrol (and equivalent prednisone) will be allowed * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Study sites (2)
CA
- City of Hope Medical Center · Duarte, CA 91010Amandeep Salhotra · Study contact · 626-218-2405 · asalhotra@coh.orgAmandeep Salhotra · Principal investigatorMore trials in Duarte
OH
- Cleveland Clinic Cancer Center · Cleveland, OH 44195Abhay Singh, MD, MPH · Study contact · 866-320-4573 · singha21@ccf.orgAbhay Singh, MD, MPH · Principal investigatorMore trials in Cleveland