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

PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

September 23, 2015

Primary Completion Date

January 24, 2023

Study Completion Date

January 24, 2023

Conditions
Leukemia
Interventions
DRUG

Alemtuzumab

"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."

DRUG

Etoposide

"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."

DRUG

Dexamethasone

"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."

DRUG

Methotrexate

Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks during the Induction Phase.

BEHAVIORAL

Phone Call

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.

DRUG

Tocilizumab

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.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER

NCT02385110 - Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis | Biotech Hunter | Biotech Hunter