Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Mycophenolate mofetil (MMF)
Mycophenolate Mofetil · 1 trial · 1 indication
Will determine the safety and tolerability of ruxolitinib monotherapy (part A) and ruxolitinib plus azacitidine therapy (part B). DLTs will be used to identify a maximum tolerated dose. Dose levels will either be de-escalated, escalated, or retained-according to pre calculated Bayesian Optimal Interval decision rules.
TRAEs of grade 3 and higher experienced during treatment with the doublet of ruxolitinib + azacitidine will be reported (with frequencies and percentages) as a co-primary endpoint. TRAEs are defined as adverse events that are definitely or possibly attributable to study treatment. Will be assessed using Common Terminology Criteria for Adverse Events version 5.0, where adverse events are assessed on a scale of 1-5, with higher scores indicating worse outcomes.
| Arm | Type | Description |
|---|---|---|
| Treatment (ruxolitinib, azacitidine) | EXPERIMENTAL | See Detailed Description. |
| Name | Type | Description |
|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | PROCEDURE | Undergo alloHSCT |
| Azacitidine | DRUG | Given IV |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Aspiration | PROCEDURE | Undergo bone marrow aspiration |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy |
| Cyclophosphamide | DRUG | Given IV |
| Echocardiography Test | PROCEDURE | Undergo ECHO |
| Electronic Health Record Review | OTHER | Ancillary studies |
| Multigated Acquisition Scan | PROCEDURE | Undergo MUGA |
| Mycophenolate Mofetil | DRUG | Given PO or IV |
| Reduced-Intensity Transplant Conditioning Procedure | OTHER | Undergo SOC RIC or NMA conditioning |
| Ruxolitinib | DRUG | Given PO |
| Survey Administration | OTHER | Ancillary studies |
| Tacrolimus | DRUG | Given PO or IV |
Inclusion Criteria: * PART A: Willingness to provide written informed consent before any study-specific procedures or interventions are performed. For participants unable to independently provide consent, a legally authorized representative (LAR) must provide consent * PART A: Age ≥ 18 years, at th...
Mycophenolate Mofetil is being studied for use in Acute Myeloid Leukemia (AML) as part of a Phase 1 clinical trial. The trial combines ruxolitinib with azacitidine maintenance therapy for patients with AML undergoing reduced intensity allogeneic stem cell transplantation. It is an investigational small molecule in early-stage clinical development.
Mycophenolate Mofetil is an immunosuppressant that inhibits inosine monophosphate dehydrogenase, an enzyme needed for guanine nucleotide synthesis in lymphocytes. This selectively blocks T and B cell proliferation. In the context of the AML trial, it is used to prevent graft-versus-host disease after stem cell transplantation.
Mycophenolate Mofetil is being developed by Incyte Corporation, traded on the NASDAQ under the ticker INCY. The company is conducting a Phase 1 clinical trial of the drug in Acute Myeloid Leukemia. Incyte is a biopharmaceutical company focused on oncology and inflammation.
Mycophenolate Mofetil is in Phase 1 clinical development for Acute Myeloid Leukemia. It is an investigational drug and has not been approved by the FDA for this indication. The ongoing trial is recruiting patients and is not yet completed.
Mycophenolate Mofetil is being evaluated in one active Phase 1 trial, NCT07548983, titled 'Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation.' The trial is recruiting 40 patients in the United States.
Yes, Mycophenolate Mofetil is the same as Mycophenolate mofetil (MMF). MMF is a common abbreviation for the drug. In the context of this Phase 1 trial, it is being studied in combination with ruxolitinib and azacitidine for Acute Myeloid Leukemia patients.