Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Leukemia
In brief
The study proposes the use of Fludarabine, Busulfan, Anti Thymocyte Globulin Rabbit (ATG) and Total Body Irradiation as a preparative regimen before hematopoietic stem cell transplant from unrelated donor peripheral blood stem cells (PBSC). The hypothesis states that the 100 day mortality after this type of transplant will be significantly below the accepted standards, which is about 30% for unrelated donors.
Key facts
- Study ID
- NCT00679536
- Run by
- Ann & Robert H Lurie Children's Hospital of Chicago
- People needed
- 30
- Starts
- 2008-05-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2014-01-23
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ages 0-21
- AML in one of the following stages:
- Having preceding myelodysplasia (MDS)
- High Risk cytogenetics
- Requiring > 2 cycles chemotherapy to obtain complete remission
- High allelic ratio FLT3/ITD+,
- Standard risk cytogenetics with positive MRD at end of Induction
- Second or greater CR
- First relapse with < 25% blasts in bone marrow
- With therapy-related AML whose prior malignancy has been in remission for at least 12 months
- ALL in one of the following stages:
- High risk first remission, defined as:
- Ph+ ALL; or,
- MLL rearrangement with slow early response [defined as having M2 (5-25% blasts) or M3 (>25% blasts on bone marrow examination on Day 14 of induction therapy)]; or,
- Hypodiploidy (< 44 chromosomes or DNA index < 0.81); or,
- End of induction M3 bone marrow; or,
- End of induction M2 marrow or MRD>1% with M2-3 marrow or MRD>1% at Day 42.
- High-risk infant ALL defined as age <6 months at diagnosis with MLL (11q23) translocation.
- High risk second remission, defined as:
- Bone marrow relapse < 36 months from induction; or >36 mths if a matched sibling donor is available
- T-lineage relapse at any time; or,
- Very early isolated CNS relapse (<18 months from diagnosis); or,
- Slow reinduction (M2-3 at Day 28) after relapse at any time.
- Any third or subsequent CR.
- Biphenotypic or undifferentiated leukemia in any CR or if in first relapse must have < 25% blasts in bone marrow
You may not qualify if…
- Inability to give informed consent or assent
- Inability to obtain a suitable donor
- Patient who is HIV-positive
- Patient who has active Hepatitis B
- Patient who is pregnant
- Patient who is otherwise considered unsuitable for transplant at the discretion of the principal investigator.
Where it is running
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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