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Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia

NCT01670084 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-10-30

No results posted yet for this study

Summary

In this study researchers want to find out more about the side effects of a new drug for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic myelogenous leukemia (CML) blastic phase (BP) and if this disease will respond better to nilotinib combined with standard hyper-CVAD therapy rather than hyper-CVAD alone. Hyper-CVAD is a combination of cyclophosphamide, mesna, vincristine (vincristine sulfate), doxorubicin (doxorubicin hydrochloride), dexamethasone, methotrexate, cytarabine, and rituximab (only for patients with cluster of differentiation \[CD\]20 positive disease). Researchers don't know all the ways that this drug may affect people

Conditions

  • B-cell Adult Acute Lymphoblastic Leukemia
  • Blastic Phase Chronic Myelogenous Leukemia
  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
  • Untreated Adult Acute Lymphoblastic Leukemia

Interventions

DRUG

nilotinib

Given PO

BIOLOGICAL

rituximab

Given IV

DRUG

cyclophosphamide

Given IV

DRUG

doxorubicin hydrochloride

Given IV

DRUG

vincristine sulfate

Given IV

DRUG

methotrexate

Given IV or IT

DRUG

cytarabine

Given IV or IT

DRUG

prednisone

Given PO

DRUG

mesna

Given IV

DRUG

dexamethasone

Given IV or PO

DRUG

leucovorin calcium

Given IV

Sponsors & Collaborators

Principal Investigators

  • Aref Al-Kali, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT01670084 on ClinicalTrials.gov