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Status:

UNKNOWN

Combination Chemotherapy Followed By Donor Stem Cell Transplant in Treating Patients With Hemophagocytic Lymphohistiocytosis

Lead Sponsor:

Children's Cancer and Leukaemia Group

Conditions:

Nonneoplastic Condition

Eligibility:

All Genders

Up to 17 years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of hemophagocytic lymphohistiocytosis cells, either by killing the cells or by stopping them from dividing. Giving more ...

Detailed Description

OBJECTIVES: Primary * Provide and evaluate revised induction and maintenance therapy comprising etoposide, dexamethasone, and cyclosporine, in terms of achieving and maintaining an acceptable clinic...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Newly diagnosed hemophagocytic lymphohistiocytosis (HLH) meeting 1 of the following criteria\*:
  • Diagnosis by molecular/genetic methods
  • Diagnosis by meeting 5 out of 8 of the following criteria:
  • Clinical criteria:
  • Fever
  • Splenomegaly
  • Laboratory criteria:
  • Cytopenias affecting ≥ 2 of 3 lineages in the peripheral blood, including the following:
  • Hemoglobin \< 9.0 g/dL (\< 10.0 g/dL in infants \< 4 weeks of age)
  • Platelet count \< 100,000/mm\^3
  • Neutrophil count \< 1,000/mm\^3
  • Hypertriglyceridemia and/or hypofibrinogenemia:
  • Fasting triglycerides ≥ 3.0 mmol/L (i.e., ≥ 265 mg/dL)
  • Fibrinogen ≤ 1.5 g/L
  • Histopathologic criteria:
  • Hemophagocytosis in bone marrow, spleen, or lymph nodes
  • No evidence of malignancy
  • New diagnostic criteria:
  • Low or absent natural killer (NK) cell activity
  • Ferritin ≥ 500 mcg/L
  • Soluble CD25 (i.e., soluble interleukin-2 receptor) ≥ 2,400 U/mL NOTE: \*Patients who do not meet the diagnostic criteria for HLH but who have a strong clinical suspicion of HLH may be eligible at the discretion of the investigator
  • Primary HLH (i.e., familial hemophagocytic lymphohistiocytosis \[FLH\]) OR secondary HLH (i.e., severe acquired form of HLH)
  • Acceptable donor meeting 1 of the following criteria:
  • HLA-identical related donor
  • Matched unrelated donor
  • Mismatched unrelated donor
  • Familial haploidentical donor
  • PATIENT CHARACTERISTICS:
  • Not specified
  • PRIOR CONCURRENT THERAPY:
  • No prior cytotoxic treatment for HLH
  • No prior cyclosporine treatment for HLH

Exclusion

    Key Trial Info

    Start Date :

    March 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    288 Patients enrolled

    Trial Details

    Trial ID

    NCT00334672

    Start Date

    March 1 2006

    Last Update

    September 17 2013

    Active Locations (13)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (13 locations)

    1

    Birmingham Children's Hospital

    Birmingham, England, United Kingdom, B4 6NH

    2

    Institute of Child Health at University of Bristol

    Bristol, England, United Kingdom, BS2 8AE

    3

    Addenbrooke's Hospital

    Cambridge, England, United Kingdom, CB2 2QQ

    4

    Watford General Hospital

    Herts, England, United Kingdom, WD18 0HB