Status:
TERMINATED
Reduced Intensity Hematopoietic Cell Transplantation for Patients With Resistant Langerhans Cell Histiocytosis
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Histiocytosis, Langerhans-cell
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * To determine the overall and disease-free survival of poor-risk pediatric patients with Langerhans cell histiocytosis at 1 and 3 years after reduced-intensity hematopoietic cel...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00618540
Start Date
January 1 2007
End Date
May 1 2013
Last Update
December 28 2017
Active Locations (1)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455