Phase 2 Study Of Imetelstat for Patient With Myelodysplastic/Myeloproliferative Neoplasms
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn if imetelstat can help to control MDS/MPNs.
Eligibility criteria
Qualifiers
Age ≥18 years as MF and CMML are very rare diseases in the pediatric population.
CMML-1 or CMML-2 with resistance or intolerance to hydroxyurea (if myeloproliferative subtype defined by WBC >13x109/L) or with no response or intolerance to 4 cycles of azacitidine or decitabine or relapse or progression after any number of cycles. CMML-1 Participants with Hgb <11g/dL, TSS score 20 or splenomegaly (defined as >5cm under the lower costal margin by physical exam or >12cm by imaging) in which hydroxyurea or HMA therapy is not indicated will also be eligible.
MDS/MPN with neutrophilia (previous atypical CML) or MDS/MPN-NOS with either >5% bone marrow blasts, Hgb <11g/dL or requiring transfusions, platelet count >450x109/L, TSS symptom score 20 or splenomegaly >5cm under the lower costal margin (or >12cm by imaging).
MDS/MPN with SF3B1 mutation and thrombocytosis (prior MDS/MPN-RS-T) with Hgb <11g/dL or requiring transfusions or with platelet count >450x109/L who have no response or failure to erythroid stimulating agents or who are unlikely to benefit due to endogenous erythropoietin levels >500mU/mL or who have intolerance or resistance to hydroxyurea.
Disqualifiers
Participants who are currently receiving treatment for a malignancy (not including basal cell carcinoma,nonmelanoma skin cancer, cervical carcinoma in situ, early-stage breast cancer or localized prostate cancer treated with hormone therapy). Participants with history of other cancers should be free of disease for at least 2 years prior to the Screening Visit or not requiring active treatment at the time of enrollment.
Participants who are receiving any other investigational agents within 7 days of C1D1 or who have received prior imetelstat therapy.
Active, uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been initiated and, at the time of screening, there is no evidence of infection worsening, such as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs, or radiographic findings attributable to infection.
Platelet count <50x109/L prior to enrollment and treatment initiation except if related to either recent treatment for MDS/MPN or treatment with cytotoxic therapy for any other reason.
Trial design
Treatments tested in this trial
- Imetelstat
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Geron Corporation
Collaborator
Source ClinicalTrials.gov