Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

Active:	Yes
Cancer Type:	Leukemia	NCT ID:	NCT02303821
Trial Phases:	Phase I	Protocol IDs:	CFZ008 (primary) NCI-2014-02601 2014-001633-84
Eligibility:	1 Months - 21 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Amgen, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT02303821

Summary

The purpose of Phase 1b of this study is to:

- Asses the safety, tolerability and activity of carfilzomib, alone and in combination
with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic
leukemia (ALL).

- Determine the maximum tolerated dose (MTD) and to recommend a phase 2 dose of
carfilzomib in combination with induction chemotherapy.

The purpose of Phase 2 of this study is to compare the rate of complete remission (CR) of
carfilzomib in combination with vincristine, dexamethasone, PEG asparaginase, daunorubicin
(VXLD) at the end of induction therapy to an appropriate external control.

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