A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies

Completed · Phase 2

Conditions studied: Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Biphenotypic Leukemia, Pre-leukemic Syndromes, Monosomy 7, Bone Marrow Clonal Malformations, Juvenile Myelomonocytic Leukemia, Myelodysplastic Syndromes, Chronic Myelogenous Leukemia

In brief

There is no curative therapy once acute leukemia patients relapse after transplant. Patients who develop clinically significant graft versus host disease (GVHD) have a lower rate of relapse than those who do not develop GVHD. We are initiating this study of post-transplant fast withdrawal of immunosuppression and donor lymphocyte infusions, with a goal of achieving full donor chimerism in children with hematologic malignancies. If our hypothesis that full donor chimerism results in leukemia-free survival is correct, using immune modulation to achieve full donor chimerism should decrease relapse rate and thus increase survival. The goal of this Phase II study is to identify if achieving full donor chimerism in whole blood CD3+ and leukemia-specific (CD14/15+, CD19+, CD33+ and CD34+) subset may decrease the risk of relapse of patients undergoing allogeneic transplant for hematologic malignancy.

Key facts

Study ID

NCT01036009

Run by

University of California, San Francisco

People needed

43

Starts

2009-10-01

Expected to finish

2015-07-01

Last updated by the study team

2016-06-23

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 6 months - 25 years.
• Diagnoses of acute leukemia (AML, ALL, biphenotypic leukemia), pre-leukemic syndromes (monosomy 7 or other bone marrow clonal malformations), JMML, myelodysplastic syndromes or CML.
• Undergoing an allogeneic transplant as standard care.
• Performance status: Karnofsky/Lansky>60%.
• Availability of pre-transplant recipient's DNA and donor's DNA for chimerism testing. This could be DNA or material from which DNA could be extracted. Frozen blood would be preferred. For some patients, post transplant specimens that are not infiltrated with donor cells may be used.
• Bone marrow or PBMTC as stem cell source.HLA matching: donor and recipient should be matched at a minimum of 7/8 antigens (A,B,C and DrB1) for bone marrow and PBMTC transplants.
• No history of ≥grade III acute GVHD.

You may not qualify if…

• Treatment on other experimental protocols, if withdrawal of immunosuppression interferes with procedures of follow-up on the primary study.
• Leukemia relapse defined as > 5% blasts on bone marrow exam or >1% leukemia cells by immunoflow MRD, or presence of extramedullary leukemia.
• History of acute GVHD ≥ stage III or with any degree of active acute or cGVHD.
• On steroids for any reason.
• Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator.
• Cells for DLI cannot be obtained from the donor.

Where it is running

• University of California — San Francisco, California, United States
• All Children's Hospital — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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