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AML

Criteria to qualify for study: Drug used in study:
  • Must refuse or not be a candidate for intensive induction chemo.
  • Previously treated subjects should have evidence of persistent or recurrent AML
  • Newly Diagnosed AML or previously treated

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

An Open-Label Multicenter Phase I trial to evaluate the Safety, Pharmacokynetics and Pharmacodynamic of Splicing Modulator H3B-800 for Subjects with AML.

Criteria to qualify for study: Drug used in study:
  • Phase 1: Subjects with confirmed relapsed or refractory
  • AML with a documented FLT3 and/or Ras mutation, or age ≥ 60 years with newly diagnosed FLT3+ and/or Ras+ AML and not eligible for standard induction chemotherapy, or FLT3+ and/or Ras+, high-risk MDS/CMML (defined as ≥ 10% peripheral blood or marrow blasts and International Prognostic Scoring System [IPSS] score ≥ 2) and relapsed or refractory to prior therapy
    Phase 2: Subjects with confirmed relapsed or refractory AML with a documented FLT3 and/or Ras mutation, or age ≥ 60 years with newly diagnosed FLT3+ and/or Ras+ AML and not eligible for standard induction chemotherapy

AML29 BSC-101-01 Strategia Therapeutics

A Phase 1/2a study of E6201 for the treatment of advanced hematologic malignancies with FLT3 and or Ras mutations, including Acute Myeloid Leukemia (AML), Myelodysplastic syndrome (MDS) or Chronic myelomonocytic leukemia (CMML)

Criteria to qualify for study: Drug used in study:
  • Newly Diagnosed older patients

AML 31 SCRi Seattle Genetics SGN33A-005

A Randomized, Double-Blind Phase 3 Study of Vadastuximab Talirine (SGN-CD33A) Versus Placebo in Combination with Azacitidine or Decitabine in the Treatment of Older Patients with Newly Diagnosed AML

Must be unfit or unwilling to receie standard intensive induction chemo / Favorable Karyotypes exlcuded / WBC < 30,000 / ECOG </= 2

Criteria to qualify for study: Drug used in study:
  • Newly Diagnosed

AML 35 CNTX-CX-01-2015 AML-1 Cantex

A Randomized, Phase II Study of CX-01 Combined with Standard Induction Therapy for Newly Diagnosed AML

Group 1 Idarubicin + Cytarabine
Group 2 Idarubicin + Cytarbine +lower dose CX-01
Group 3 Idarubicin + cytarbine + higher dose CX-01

Newly diagnosed untreated AML / Age 60 or above / ECOG 0 -2 / LVEF > 45% / CrCl >30mL/min / bili < 2.5 x ULN / prior treatment for AML / Excluded history of other active malignant diseases within 3 years prior / excluded pts receiving any form of anticoagulant therapy / excluded known bleeding disorder or coagulation abnormality

Criteria to qualify for study: Drug used in study:
  • Relapsed or Refractory

Hemref 43 TTI-621 Trillium

A Phase 1a/1b Dose Escalation and Expansion Trial of Single agen TTI-621, a Novel Biologic Targeting CD47, in Subjects with Relpased of Refractory Hematologic Malignancies Phase 1a Escalation / Advanced lymphoma after failure of at least 2 prior regimens with at least 1 site of measurable disease (> 1.5 cm in long axis or > 1.0 cm in both long and short axis / ANC > 1.5 / PLT > 75 / HGB > 10 in absence of transfusion and growth factors for at least 28 days /ECOG 0,1 or 2 /

Criteria to qualify for study: Drug used in study:
  • Hemeref51 Medimmune

A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of MEDI7247 in Patients with Selected Relapsed/Refractory Hematological Malignancy "ECOG 0-1, Liver Function Tests: AST and ALT ? 3 × ULN; ? 5 × the ULN for either value if due to leukemia or lymphoma involvement, and serum TBL ? 1.5 × ULN, unless consistent with Gilbert’s syndrome (ratio between total and direct bilirubin > 5), for which TBL ? 2.5 × ULN is allowed. AML - Hydroxyurea, if clinically indicated, is permitted but must be stopped 24 hours prior to the first scheduled dose of MEDI7247 MM-May have received approved agents or radiation within 14 days OR immunotherapy within 28 days of the first scheduled dose of MEDI7247"