Criteria to qualify for study: Drug used in study:
  • MDS IPSS High-Risk or Intermediate 2
  • Intolerant of Hypomethylating Agents or not have responded to 4 cycles of decitabine or 6 cycles of azacidine
  • Progressed after initation of HMA

HEMREF 48 - H3B-8800-101 H3 Biomedicine and Eisai

An Open-label, Multicenter Phase 1 trial to evaluate the safety, Pharmacokynetics and Pharmacodynamic of splicing modulator H3B-8800 for subjects with Myelodysplastic Syndromes.

Criteria to qualify for study: Drug used in study:
  • Low or Intermediate 1 MDS or non- proliferative CMML (WBC <12.000/ must have symptomatic anemia untransfused with hgb <10 within 8 weeks of registration or with RBC transfusion - dependence (>2 units/month) confirmed for a minimum of 8 weeks before randomization. Or patients with platelet < 50 and hgb > 10. / 28 day washout for all disease modifying therapy for MDS / Must not have received prior therapy with lenalidomide (for more than 2 months) nor eltrombopag / ECOG 0-3 /

MDS20 RV – MDS – P1-0645

Phase II Study of Lenalidomide and Eltrombopag in Patients with symptomatic Anemia in Low or Intermediate Myelodysplastic Syndrome.