AZD6738 for Patients With Progressive MDS or CMML (NCT03770429) | Clinical Trial Compass
Active — Not RecruitingPhase 1
AZD6738 for Patients With Progressive MDS or CMML
United States52 participantsStarted 2019-08-05
Plain-language summary
This research study is studying a research drug called AZD6738 as a possible treatment for Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia .
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
Patients must have a diagnosis of recurrent, persistent, or progressive myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) according to WHO 2016 diagnostic criteria:
* For patients with higher-risk MDS (Intermediate, High, or Very High by IPSS-R, score \>3.5), they must have been unresponsive to 4 cycles of decitabine or 6 cycles of azacitidine, progressed on any prior HMA, or intolerant of prior treatment with either azacitidine or decitabine (HMA) chemotherapy.
* For patients with CMML, they must have received prior HMA chemotherapy and have been unresponsive to, progressed on, or be intolerant of this therapy; or those who decline or are not felt to be candidates for HMA chemotherapy.
* Patients with MDS or CMML that has recurred after prior allogeneic stem cell transplantation.
* For patients with lower-risk MDS (Low or Intermediate by IPSS-R, score ≤ 3.5, or any score post-HMA), they must be transfusion-dependent according to IWG criteria and must either be unresponsive to/progressed after prior ESA therapy or have an erythropoietin level \> 500 U/L, who are not felt to be candidates for or lack other treatment options.
* Female and male patients aged ≥ 18 years.
* ECOG performance status ≤2.
* All participants must have adequate organ and marrow function as defined below within 21 days prior to study enrollment:
* Total bilirubin \< 1.5 mg/dL unless due to Gilbert's (\<3.0 mg/dL)
* AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional uppe…
What they're measuring
1
Safety of AZD6738 in MDS and CMML (Incidence of dose limiting toxicities)