UnknownPhase 3

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

United Kingdom288 participantsStarted 2006-03

Plain-language 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 than one drug (combination chemotherapy) may kill more hemophagocytic lymphohistiocytosis cells. A donor stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Cyclosporine and methotrexate may stop this from happening. PURPOSE: This phase III trial is studying how well combination chemotherapy followed by a donor stem cell transplant works in treating patients with hemophagocytic lymphohistiocytosis.

Who can participate

Age range

17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Survival

Trial details

NCT IDNCT00334672

SponsorChildren's Cancer and Leukaemia Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-11

View on ClinicalTrials.gov More Nonneoplastic Condition trials