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Monoclonal Antibodies

Etoposide for Leukemia

Phase 2
Waitlist Available
Led By Naval Daver, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial is studying the side effects of adding alemtuzumab or tocilizumab to the drug combination of etoposide and dexamethasone in people with HLH, and how well the drug combination works in treating HLH.

Eligible Conditions
  • Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Free Survival
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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2: Etoposide + Dexamethasone + TocilizumabExperimental Treatment6 Interventions
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
Group II: Group 1: Alemtuzumab + Etoposide + DexamethasoneExperimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Alemtuzumab
2004
Completed Phase 4
~1890
Dexamethasone
2007
Completed Phase 4
~2590
Phone Call
2016
Completed Phase 4
~20190
Tocilizumab
2012
Completed Phase 4
~1840
Methotrexate
2013
Completed Phase 4
~3800

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,965 Previous Clinical Trials
1,804,899 Total Patients Enrolled
451 Trials studying Leukemia
31,482 Patients Enrolled for Leukemia
Naval Daver, MDPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
397 Total Patients Enrolled
7 Trials studying Leukemia
365 Patients Enrolled for Leukemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis
2015. "Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02385110.
~2 spots leftby Apr 2025
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