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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT01670084
Phase
PHASE2
Status
Withdrawn

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • nilotinib — DRUG
    Given PO
  • rituximab — BIOLOGICAL
    Given IV
  • cyclophosphamide — DRUG
    Given IV
  • doxorubicin hydrochloride — DRUG
    Given IV
  • vincristine sulfate — DRUG
    Given IV
  • methotrexate — DRUG
    Given IV or IT
  • cytarabine — DRUG
    Given IV or IT
  • prednisone — DRUG
    Given PO
  • mesna — DRUG
    Given IV
  • dexamethasone — DRUG
    Given IV or PO
  • leucovorin calcium — DRUG
    Given IV

Study Details

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

Key Dates

Start date
Dec 31, 2012
Status verified
Oct 2015
Primary completion
Sep 30, 2015
Completion
Sep 30, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nilotinib, combination chemotherapy)
    See Detailed Description

Primary Outcome Measure

Disease-free survival rate, defined as a patient who is alive and relapse-free, in patients who achieve a CR during the first 2 courses out to 2 years [ Time Frame: 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo ClinicRochesterMinnesota55905-

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By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic· Rochester, MN

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