RecruitMe Clinical Trial

CFZ008; Phase 1b/2 Study of Carfilzomib in Combination with Dexamethasone, Mitoxantrone, PEG asparaginase, and Vincristine (UK R3Induction Backbone) in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia
A study for children with acute lymphoblastic leukemia using study drug carfilzomib
Sponsor:Amgen
Enrolling:Male and Female Patients
Age Range:Between 1 and 21 years old
IRB Number:AAAO2351
U.S. Government ID:NCT02303821
Contact: Rebecca Zylber, NP: 212-305-7212 / rjv2107@cumc.columbia.edu
Additional Study Information:

The purpose of this study is to find out the effects and safety of the study drug called carfilzomib alone and in combination with induction chemotherapy, for the treatment of children/adolescents with relapsed or refractory acute lymphoblastic leukemia (ALL). Participants will receive carfilzomib in combination with induction chemotherapy, comprising either an R3 backbone of dexamethasone, mitoxantrone, PEG-asparaginase, and vincristine (Dose Escalation 1) or a VXLD backbone of vincristine, dexamethasone, PEG-asparaginase, and daunorubicin (Dose Escalation 2). Participants with stable disease or better response at the end of the Induction Cycle will be offered an optional cycle of Consolidation chemotherapy. To be eligible, participant must have had 1 or more prior therapeutic attempts, age 21 years or younger at the time of initial ALL diagnosis and age 1 year at the time of study treatment initiation. Subjects must have a diagnosis of relapsed or refractory ALL with 5% blasts in the bone marrow (M2 or M3 disease), with or without extramedullary disease.

Do You Qualify?
Does your child have a diagnosis of relapse or refractory acute lymphoblastic leukemia (ALL)?YesNo
Are you between 1 and 21 years of age?YesNo
Have you received prior therapy?YesNo
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You may be eligible for this study

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Who Can I Contact?
For more information, please contact:
Rebecca Zylber, NP
Email: rjv2107@cumc.columbia.edu
Phone: 212-305-7212