Status:
COMPLETED
Reduced Intensity Transplant Using Extracorporeal Photopheresis
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsors:
Mallinckrodt
Conditions:
Leukemia
Cancer
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
Stem cell transplantation may be used to cure childhood cancers, and other diseases. Traditionally, stem cell transplants use high doses of chemotherapy and radiation. This regimen may cause significa...
Detailed Description
This study tests the feasibility of a reduced intensity preparative regimen for stem cell transplant including extracorporeal photopheresis (ECP), busulfan, and fludarabine in patients with leukemia, ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Weight \> 25 kg
- Patients with acute lymphoblastic leukemia (ALL) who are in CR (complete remission; \< 5% blasts in bone marrow and no active central nervous system disease) who:
- Are in second remission with an initial remission of \< 36 months.
- Patients with "high risk" disease in CR1, defined by karyotype abnormalities such as presence of (9;22) translocation, monosomy 7, or monosomy 5; and/or patients with slow initial response (initial remission not reached within four weeks from diagnosis).
- Are in third (or subsequent) remission
- Experience isolated extramedullary relapse while on therapy
- Have experienced relapse following myeloablative stem cell transplant
- Are WT1+ following induction therapy
- Patients with acute myelogenous leukemia (AML) who:
- Are in first remission and remain WT1 positive.
- Are in second remission
- Are in initial partial remission (\< 20% blasts in bone marrow)
- Experience relapse following myeloablative stem cell transplant
- Patients with relapsed lymphoma whose residual disease appears to be chemo-responsive and non-bulky (\< 5 cm largest diameter)
- Patients with chronic myelogenous leukemia (CML) in chronic phase who:
- Don't achieve remission (molecular or cytogenetic) by 1 year of diagnosis with therapy (imatinib mesylate or interferon)
- Have a rising quantitative bcr/abl on imatinib mesylate (molecular relapse)
- Had developed accelerated phase regardless of therapy but are now back in second chronic phase
- Patients with recurrent solid tumors (neuroblastoma, Ewing's sarcoma, melanoma, rhabdomyosarcoma)
- Patients with myelodysplastic syndrome
- Patients with refractory anemia (RA) and refractory anemia with excess blasts (RAEB) are eligible, but refractory anemia with excess blasts in transformation (RAEB-T) patients are only eligible if treated to \< 20% blasts with chemotherapy
- Patients with selected immunodeficiencies such as Wiskott-Aldrich syndrome or hyper-IgM syndrome
- Patients with metabolic diseases such as Niemann-Pick or adrenoleukodystrophy
- Patients with bone marrow failure syndromes, including aplastic anemia
- Adequate venous access
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00179790
Start Date
July 1 2005
End Date
January 1 2015
Last Update
March 6 2017
Active Locations (1)
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1
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60625