Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02385110
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Alemtuzumab — DRUG
    Group 1 and 2 Induction Phase: Alemtuzumab total dose of 1.0 mg/kg subcutaneously or by vein over 4 days (days 1-4) during the 8 week induction phase. Day 1 0.1 mg/kg, Day 2 0.3 mg/kg, Day 3 0.3 mg/kg, Day 4 0.3 mg/kg. Group 1 Maintenance Phase: 0.2 mg/kg once every 4 weeks for 6 weeks.
  • Etoposide — DRUG
    Induction Phase: 150 mg/m2 given by vein once a week for 8 weeks. Maintenance Phase: Participants who have evidence of refractory disease or budding relapse during the maintenance phase may revert back to receiving Etoposide.
  • Dexamethasone — DRUG
    Induction Phase: 10 mg/m2 for 1 week followed by Dexamethasone 5 mg/m2 for 2 weeks followed by Dexamethasone 2.5 mg/m2 for 2 weeks followed by Dexamethasone 1.25 mg/m2 for 2 weeks. Maintenance Phase: 1.25 mg/m2 by mouth three times a week for 16 weeks.
  • Methotrexate — DRUG
    Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks during the Induction Phase.
  • Phone Call — BEHAVIORAL
    If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes.
  • Tocilizumab — DRUG
    Induction Phase: Tocilizumab at 4 to 8 mg/kg by vein. Day 1 0.1 mg/kg,Day 2 0.3 mg/kg, Day 3 0.3 mg/kg, Day 4 0.3 mg/kg.

Study Details

The goal of this clinical research study is to compare the effect of adding either alemtuzumab or tocilizumab to the drug combination of etoposide and dexamethasone in controlling HLH. The safety of the drug combinations will also be studied. This is an investigational study. Alemtuzumab, etoposide, tocilizumab, and dexamethasone are not FDA approved for the treatment of HLH. Etoposide is FDA approved and commercially available for the treatment of testicular cancer and lung cancer. Alemtuzumab is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia. Dexamethasone is a steroid used to reduce inflammation. Tocilizumab is FDA approved and commercially available for the treatment of arthritis. The combination of alemtuzumab, etoposide, tocilizumab, and dexamethasone to treat HLH is investigational. The study doctor can explain how the drugs are designed to work. Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.

Key Dates

Start date
Sep 23, 2015
Status verified
Dec 2023
Primary completion
Jan 24, 2023
Completion
Jan 24, 2023

Study Design

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

Arms

  • Experimental: Group 1: Alemtuzumab + Etoposide + Dexamethasone
    Induction Phase: Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide, and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks. Dexamethasone by vein on Days 1-7 of the induction phase. Maintenance Phase: Starts Post Induction Phase for16 weeks. Participants receive Alemtuzumab once every 4 weeks and Dexamethasone three times per week. Participants who have evidence of budding relapse may revert back to receiving Etoposide. If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes.
  • Experimental: Group 2: Etoposide + Dexamethasone + Tocilizumab
    Induction Phase: Participants receive Tocilizumab by vein over 60 minutes on Day 1 or Day 2. Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks. Maintenance Phase: Starts Post Induction Phase and will last 16 weeks. Tocilizumab not given in the Maintenance Phase. Dexamethasone three times per week. If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes

Primary Outcome Measure

Number of Participants With a Response to Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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