Skip to main content

AML

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

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:
  • Must be unfit or unwilling to received standard intensive induction chemo
  • Favorable Karyotypes are excluded
  • WBC < 30,000
  • ECOG ≤ 2

AML 31

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 acute myeloid leukemia (AML)

Criteria to qualify for study: Drug used in study:

Part A:

  • Must be relapsed or refractory with blast >5%
  • Must have received 2 prior inductions including a least 1 intensive chemo or received 1 prior intensive induction and have at least 1 high-risk factor defined by protocol
  • Must have matched donor
  • LVEF> 45%
  • DLCO > 50%

Part B:

  • Status post transplant with active AML (> 5% blasts)
  • ANC>/=1000
  • PLT>/=50 without transfusion in 1 week
  • CNS involvement excluded

AML 30

A phase 1/2 study of vadastuximab talirine administered in sequence with allogeneic hematopoietic stem cell transplant in patients with relapsed or refractory acute myeloid leukemia

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:
  • Relapsed or Refractory
  • Patients must have no available approved therapies that confer clinical benefit
  • Peripheral blood blast count must be ≤ 30
  • No APL
  • No active CNS disease
  • Patients cannot be on warfarin

SCRI HEMREF-38

A Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Glutaminase Inhibitor CB-839 in Patients with Relapsed and/or Treatment-Refractoy Leukemia

Criteria to qualify for study: Drug used in study:
  • Must have available archival or recent acquired bone marrow biopsy or tumor tissue for central review
  • Must have only received one prior therapy

AML 21 SCRI Karyopharm KCP-330-008

A Randomized, Open Label, Phase 2 Study of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) Versus Specified Physician's Choice in Patients ≥ 60 Years Old With Relapsed/Refractory Acute Myeloid Leukemia (AML) Who Are Inelibible for Intensive Chemotherapy and/or Transplantation

Criteria to qualify for study: Drug used in study:
  • Patients must have central venous access
  • Peripheral blood blast count must be 30 or less
  • No APL
  • DLCO less than 50% of predicted not allowed
  • No CNS disease

AML 23 SCRI Seattle Genetics

A Phase 1b Dose-Escalation study of SGN-CD33A in Combination with Standard of Care for Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)


1st CR/MRD

Criteria to qualify for study: Drug used in study:
  • Patients must achieved a 1st or 2nd CR or CRI /
  • Have adverse risk disease or AML for which there is othewise a substantial risk of relapse / albumin > 3.2 / bili < 1.5

AML 27 SCRI Stemline Therapeutics, STML401-0214

A Phase 1/2 Study of SL-401 as Consolidation Therapy for Adult Patients with Adverse Risk Acute Myeloid Leukemia in First CR, and/or Evidence of Minimal Residual Disease in First CR