Carfilzomib and Hyper-CVAD in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoma

NCT02293109 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-03-10

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of carfilzomib when given together with the hyperfractionated (hyper)-cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone (CVAD) chemotherapy regimen in treating patients with newly diagnosed acute lymphoblastic leukemia or lymphoma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib with combination chemotherapy may kill more cancer cells.

Conditions

  • Contiguous Stage II Adult Lymphoblastic Lymphoma
  • Noncontiguous Stage II Adult Lymphoblastic Lymphoma
  • Stage I Adult Lymphoblastic Lymphoma
  • Stage III Adult Lymphoblastic Lymphoma
  • Stage IV Adult Lymphoblastic Lymphoma
  • Untreated Adult Acute Lymphoblastic Leukemia

Interventions

DRUG

carfilzomib

Given IV

DRUG

cyclophosphamide

Given IV

DRUG

vincristine sulfate

Given IV

DRUG

doxorubicin hydrochloride

Given IV

DRUG

dexamethasone

Given PO

DRUG

methotrexate

Given IV

DRUG

cytarabine

Given IV

DRUG

leucovorin calcium

Given IV or PO

DRUG

methylprednisolone

Given IV

BIOLOGICAL

rituximab

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY
  • Mehrdad Abedi, MD

    lead OTHER

Principal Investigators

  • Mehrdad Abedi · University of California, Davis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-17
Primary Completion
2017-12-13
Completion
2018-01-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293109 on ClinicalTrials.gov