AML, MDS, or ALL

After Transplant

Criteria to qualify for study: Drug used in study:
  • Patients must have 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>1000 & PLT > 20

SCRI AML-17
A Phase II, Randomized, Comparative 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

 

 

 

 

 

 


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

 

 

 

 

 

 

 



CMML - Untreated

Criteria to qualify for study: Drug used in study:
  • Must have greater than 5% and less than 20% blasts  
  • Transplant in not allowed 
  • IPSS score must be at least 1.5 unless there is greater than 5% myeloblasts in the bone marrow.

 SCRI MDS-16 TetraLogic

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Azacitidine with or without Birinapant with a Single Arm Open-Label Run-In Phase in Subjects with Higher Risk Myelodysplastic Syndrome (MDS) or Chronic Meylomonocytic Leukemia (CMML)

 

 

 

 

 

 

 

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

 

 

 

 

 

  



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

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

 

 

 

 

 

 

 


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
  • No APL
  • DLCO less than 50% of predicted not allowed
  • No CNS disease

SCRI  SGN33A-002

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

 

 

 

 

 

 

 

 


MDS Untreated

Criteria to qualify for study: Drug used in study:
  • Must have greater than 5% and less than 20% blasts 
  • Transplant in not allowed 
  • IPSS score must be at least 1.5 unless there is greater than 5% myeloblasts in the bone marrow.

 SCRI MDS-16 TetraLogic

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Azacitidine with or without Birinapant with a Single Arm Open-Label Run-In Phase in Subjects with Higher Risk Myelodysplastic Syndrome (MDS) or Chronic Meylomonocytic Leukemia (CMML)

 

 

 

 

 

 

 

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