Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT02419755
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib — DRUG
    Bortezomib will be given as a 1 mg/mL solution intravenous (IV) push over 3 to 5 seconds. For subcutaneous (SQ) administration, bortezomib will be mixed at 2.5 mg/ml.
  • Vorinostat — DRUG
    Vorinostat should be taken orally (PO) with food.
  • Mitoxantrone — DRUG
    Given by intravenous (IV) injection.
  • Cytarabine — DRUG
    Given by intravenous (IV) injection.
  • Methotrexate — DRUG
    Methotrexate will be given intrathecally (IT) along with hydrocortisone and cytarabine.
  • Hydrocortisone — DRUG
    Hydrocortisone will be given intrathecally (IT) along with methotrexate and cytarabine.
  • Peg-L-Asparaginase — DRUG
    Given by intravenous (IV) or intramuscular (IM) injection.
  • Erwinia L-Asparaginase — DRUG
    To be used in case of allergy or intolerance to PEG-Asparaginase. Given by intravenous (IV) or intramuscular (IM) injection.
  • Dexamethasone — DRUG
    Given orally (PO) or intravenously (IV).
  • Mercaptopurine — DRUG
    Given orally (PO).
  • Doxorubicin — DRUG
    Given intravenously (IV).

Study Details

This study will test the safety and effectiveness of adding bortezomib and vorinostat to other chemotherapy drugs commonly used to treat relapsed or refractory leukemia. Both drugs have been approved by the Food and Drug Administration (FDA) to treat other cancers in adults, but they have not yet been approved tor treatment younger patients with leukemia. PRIMARY OBJECTIVE * To estimate the overall response rate of patients with MLL rearranged (MLLr) hematologic malignancies receiving bortezomib and vorinostat in combination with a chemotherapy backbone. SECONDARY OBJECTIVES * Estimate event-free and overall-survival. * Describe toxicities experienced by participants during treatment. OTHER PRESPECIFIED OBJECTIVES * To identify all genomic lesions by comprehensive whole genome, exome and transcriptome sequencing on all patients. * To compare minimal residual disease (MRD) results by three modalities: flow cytometry, polymerase chain reaction (PCR) and deep sequencing.

Key Dates

Start date
Apr 14, 2015
Status verified
Nov 2017
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum 1: Myeloid Malignancies
    Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
  • Experimental: Stratum 2: ALL and MLM
    Participants in Stratum 2 \[Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)\] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.

Primary Outcome Measure

Overall Response Rate in All Participants [ Time Frame: End of first treatment block (up to 2 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105-

Find similar trials in Memphis, TN

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
St. Jude Children's Research Hospital· Memphis, TN

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