AML, MDS, or ALL

ALL - Relapsed or Refactory 

Criteria to qualify for study: Drug used in study:
  • Patients must have no available approved therapies that confer clinical benefit 
  • Ph+ patients must have failed prior tyrosine-kinase inhibitor therapy 
  • No APL 
  • DLCO less than 50% of predicted not allowed 
  • No CNS disease

HEMREF 38 SCRI CX-839-003 Calithera

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 Refractory Leukemia and IDH-Mutated Myelodysplastic Syndrome

 

 

 

 

 

 

 



AML, MDS, CMML

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)

COMING SOON

 

 

 

 

 

 

 

 

 

 

 

 

 


CMML - Relapsed/Refractory

Criteria to qualify for study: Drug used in study:
  • Patients must have no available approved therapies that confer clinical benefit 
  • Must have histologically confirmed diagnosis of IDH-mutated MDS 
  • No APL 
  • DLCO less than 50% of predicted not allowed 
  • No CNS disease

HEMREF 38 SCRI CX-839-003 Calithera

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 Refractory Leukemia and IDH-Mutated Myelodysplastic Syndrome

 

 

 

 

 

 

 

 

 


AML - Relapsed or Refractory

Criteria to qualify for study: Drug used in study:
  • 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 Luekemia

 

 

 

 

 

  

Criteria to qualify for study: Drug used in study:
  • Must have had 1-2 previous therapies
  • Serum differential free light chain concentration  must be ≥ 50 mg/L
  • ANC must be at least 1000  
  • PLT must be at least 75 

AMY 02  (MM 57)  SCRI Millennium C16011

A Phase 3 Randomized, Controlled, Open-Label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physician's Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis   

 

 

 

 

 

 

 

 


AML - Post Transplant

Criteria to qualify for study: Drug used in study:
  • Patients must have AML with documented FLT3 ITD mutation
  • Patient must have undergone allo transplant in CR1 with Bu/Flu, Flu/Mel, Bu/Cy, or Cy/TBI 
  • Recovery of counts by Day 42 
  • ANC must be greated than 1000 
  • PLT must be greater than 20

AML 17  SCRI  Novartis  CPKC-412AUS23

A Phase II, Randomized Trial of Standard of Care, with or without Midostaurin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients with FLT3-ITD Mutated Acute Myeloid 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

 

 

 

 

 

 

 


AML Treatment Naive

Criteria to qualify for study: Drug used in study:
  • ŸAge 60 years or older
  • ŸNo prior treatment.
  • Unlikely to benefit from    
        standard induction therapy

      Exclusions:

  • Known favorable cytogenetic risk.
  • WBC count >50K
  • Hepatic impairment
  • Treatment with CYP3A inducers / 
    inhibitors within 14 days of treatment

Millennium C15009 - CBCI-245

A Phase 1b, Open-Label, Dose-Escalation Study of MLN4924 Plus Azacitidine in Treatment-Naive Patients With Acute Myelogenous Leukemia Who Are 60 Year or Older.



 

 

 

 

 

 

 

 

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 Phae 1b Dose-Escalation study of SGN-CD33A in Combination with Standare of Care for Patients wit 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 

 

 

 

 

 

 

 


MDS Untreated

Criteria to qualify for study: Drug used in study:
  • IPSS > 1.5
  • Untreated for MDS with the exception of transfusions, growth factors
  • WBC < 20,000, excluded if prior treatment with lenalidomide or HMAs

MDS 19  SGN33A-004  Seattle Genetics

A Phase 1/2 Study of Vadastuximab Talirine (SGN33A) in Combination with Azacitidine in Patients with Previously Untreated International Prognostic Scoring System (IPSS) Intermediate -2 or High-Risk Myelodysplastic Syndrome (MDS)

COMING SOON

 

 

 

 

 

 

 

 


MDS Relapsed/Refractory

Criteria to qualify for study: Drug used in study:
  • Patients must have no available approved therapies that confer clinical benefit 
  • Must have histologically confirmed diagnosis of IDH-mutated MDS
  • No APL 
  • DLCO less than 50% of predicted not allowed 
  • No CNS disease

HEMREF 38  SCRI CX-839-003  Calithera

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 Refractory Leukemia and IDH-Mutated Myelodysplastic Syndrome