Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501)

Completed · Phase 3

Conditions studied: Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome, Natural Killer Cell Lymphoblastic Leukemia/Lymphoma

In brief

This study is a Phase III, randomized, open-label, multi-center, prospective study of single umbilical cord blood (UCB) transplantation versus double UCB transplantation in pediatric patients with hematologic malignancies.

Key facts

Study ID

NCT00412360

Run by

Medical College of Wisconsin

People needed

224

Starts

2006-12-01

Expected to finish

2014-10-01

Last updated by the study team

2021-10-28

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Two partially HLA-matched UCB units. Units must be HLA-matched minimally at 4 of 6 HLA-A and B (at intermediate resolution by molecular typing) and DRB1 (at high resolution by molecular typing) loci with the patient, and the units must be HLA-matched at 3 of 6 HLA- A, B, DRB1 loci with each other (using same resolution of molecular typing as indicated above). Two appropriately HLA-matched units must be available such that one unit delivers a pre-cryopreserved nucleated cell dose of at least 2.5 x 10\^7 per kilogram and the second unit at least 1.5 x 10\^7 per kilogram.
• Acute myelogenous leukemia (AML) at the following stages:
• High risk first complete remission (CR1), defined as the following:
• Having preceding myelodysplasia (MDS)
• High risk cytogenetics (high risk cytogenetics: del (5q) -5, -7, abn (3q), t (6;9) complex karyotype [at least 5 abnormalities],)the presence of a high FLT3 ITD-AR (> 0.4)
• Requiring more than 1 cycle of chemotherapy to obtain complete remission (CR);
• FAB M6
• Second or greater CR
• First relapse with less than 25% blasts in bone marrow
• Morphologic complete remission with incomplete blood count recovery
• Therapy-related AML for which prior malignancy has been in remission for at least 12 months
• Acute lymphocytic leukemia (ALL) at the following stages:
• High risk first remission, defined as one of the following conditions:
• Philadelphia chromosome-positive adult lymphoblastic leukemia (Ph+ ALL)
• Mixed lineage leukemia (MLL) rearrangement with slow early response (defined as having M2 [5-25% blasts] or M3 [more than 25% blasts on bone marrow examination on Day 14 of induction therapy])
• Hypodiploidy (less than 44 chromosomes or DNA index less than 0.81)
• End of induction M3 bone marrow
• End of induction M2 with M2-3 at Day 42
• Evidence of minimal residual disease (MRD). If a patient's only high risk criterion is MRD, approval by a protocol chair or protocol officer is required for enrollment. For COG centers, this will only be for MRD greater than 1 percent by flow MRD at the end of extended induction.
• High risk second remission, defined as one of the following conditions:
• Philadelphia chromosome-positive adult lymphoblastic leukemia (Ph+ ALL)
• Bone marrow relapse less than 36 months from induction
• T-lineage relapse at any time
• Very early isolated central nervous system (CNS) relapse (6 months from diagnosis)
• Slow reinduction (M2-3 at Day 28) after relapse at any time

You may not qualify if…

• Pregnant (β-positive human chorionic gonadotropin [HCG]) or breastfeeding
• Evidence of HIV infection or HIV positive serology
• Current uncontrolled bacterial, viral, or fungal infection (currently taking medication and progression of clinical symptoms)
• Autologous transplant less than 12 months prior to enrollment
• Prior autologous transplant for the disease for which the UCB transplant will be performed
• Prior allogeneic hematopoietic stem cell transplant
• Active malignancy other than the one for which the UCB transplant is being performed within 12 months of enrollment
• Inability to receive TBI
• Requirement of supplemental oxygen
• HLA-matched related donor able to donate

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• Childrens Hospital at Oakland — Oakland, California, United States
• UCSD/Rady Childrens Hospital — San Diego, California, United States
• University of California, San Francisco (Peds) — San Francisco, California, United States
• The Children's Hospital of Denver — Denver, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Florida College of Medicine (Shands) — Gainesville, Florida, United States
• Nemours Childrens Clinic — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• University of Louisville/Kosiar Children's Hospital — Louisville, Kentucky, United States
• Children's of New Orleans — New Orleans, Louisiana, United States
• DFCI/Children's Hospital of Boston — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute/Children's Hospital of Michigan — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of Mississippi — Jackson, Mississippi, United States
• Children's Mercy Hospital and Clinics — Kansas City, Missouri, United States
• New York Medical College — Valhalla, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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