Reduced Intensity Hematopoietic Cell Transplantation for Patients With Resistant Langerhans Cell Histiocytosis

Stopped early · Phase 2

Conditions studied: Histiocytosis, Langerhans-cell

In brief

RATIONALE: Giving a monoclonal antibody, such as alemtuzumab, and chemotherapy drugs, such as fludarabine and melphalan, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of abnormal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving alemtuzumab together with fludarabine and melphalan followed by a donor stem cell transplant works in treating young patients with resistant Langerhans cell histiocytosis.

Key facts

Study ID

NCT00618540

Run by

Masonic Cancer Center, University of Minnesota

People needed

1

Starts

2007-01-01

Expected to finish

2013-05-01

Last updated by the study team

2017-12-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed Langerhans cell histiocytosis (LCH) by demonstration of CD1a positivity or Birbeck granules in lesions
• Considered poor-risk, defined as multisystem disease with involvement of one or more risk organs (i.e., liver, spleen, lungs, and/or hematopoietic system)
• No isolated "lung only" LCH
• Progressive disease after one of the following treatments:
• LCH-III protocol or other standard LCH-directed therapies
• At least 1 course of the current salvage protocol (i.e., LCH-2 2005) or similar therapy (e.g., cytosine arabinoside or cladribine-based regimens)
• HLA-matched related or unrelated donor OR unrelated umbilical cord blood (UCB) available
• 1 locus mismatch for donor allowed
• Up to 2 loci mismatch for unrelated UCB allowed
• Any hematologic status (transfusion support allowed)
• Adequate hepatic, renal, cardiac, and pulmonary function to undergo reduced-intensity hematopoietic cell transplantation (RI-HCT) including the following:
• Transaminases < 5 times upper limit of normal (ULN)
• Bilirubin < 3 times ULN (unless secondary to hepatic LCH)
• Creatinine ≤ 2 mg/dL (adults) (if creatinine > 1.2 OR history of renal dysfunction, must have estimated creatinine clearance > 40 mL/min)
• Creatinine clearance > 40 mL/min (pediatrics)
• Glomerular filtration rate ≥ 50mL/min
• Negative pregnancy test

You may not qualify if…

• Decompensated congestive heart failure, uncontrolled arrhythmia, or left ventricular ejection fraction ≥ 35%
• Pulmonary failure (i.e., requiring mechanical ventilation) unless secondary to active underlying LCH
• Isolated liver sclerosis or pulmonary fibrosis unless secondary to active underlying LCH
• Uncontrolled active life-threatening infection
• Pregnant or nursing
• Less than 4 weeks after last attempted salvage chemotherapy treatment
• Other concurrent chemotherapy agents (e.g., methotrexate) during entire transplantation period up to day 100 post-transplantation

Where it is running

• Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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