Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies
NCT ID: NCT02323867
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
140 participants
INTERVENTIONAL
2014-10-31
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Alpha Beta Total Body Irradiation - total body irradiation (TBI) first
Alpha Beta Total Body Irradiation - TBI first Day Treatment
* 11 Anti-thymocyte globulin (ATG)
* 10 ATG
* 9 ATG
* 8 TBI
* 7 TBI
* 6 TBI
* 5 Thiotepa
* 4 Thiotepa
* 3 Cyclophosphamide
* 2 Cyclophosphamide
* 1 Rest 0 Transplant with alpha beta T cell depleted stem cells
No interventions assigned to this group
Alpha Beta Total Body Irradiation - TBI last
Alpha Beta Total Body Irradiation - TBI last Day Treatment
* 9 ATG
* 8 ATG
* 7 Thiotepa + ATG
* 6 Thiotepa
* 5 Cyclophosphamide
* 4 Cyclophosphamide
* 3 TBI
* 2 TBI
* 1 TBI 0 Transplant with alpha beta T cell depleted stem cells
No interventions assigned to this group
Alpha Beta Non-irradiation regimen
Alpha Beta Non-irradiation regimen Day Treatment
* 9 Busulfan + ATG
* 8 Busulfan + ATG
* 7 Busulfan +ATG
* 6 Busulfan
* 5 Thiotepa
* 4 Thiotepa
* 3 Cyclophosphamide
* 2 Cyclophosphamide
* 1 0 Transplant with alpha beta T cell depleted stem cells
Alpha Beta T cell depletion
Interventions
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Alpha Beta T cell depletion
Eligibility Criteria
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Inclusion Criteria
* Acute myeloid leukemia, primary or secondary Disease status: remission or \<10% bone marrow blasts
* Myelodysplasia
* Acute lymphoblastic leukemia Disease status: in hematologic remission
* Chronic myelogenous leukemia Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase.
* Mixed lineage or biphenotypic acute leukemia
* Lymphoblastic lymphoma Disease status: remission
* Burkitt's lymphoma/leukemia: Disease status- in remission
2. Acceptable organ status clearance
3. No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic
4. Signed informed consent.
5. Negative pregnancy test for females of childbearing potential.
Exclusion Criteria
2. No suitable donor
3. Received previous allogeneic transplant
Donor must be either unrelated, mismatched up to one antigen/one antigen and one allele or a related, HLA match other than a sibling.
23 Years
ALL
No
Sponsors
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Children's Hospital of Philadelphia
OTHER
Responsible Party
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Timothy Olson
Medical Director, Hematopoietic Stem Cell Transplantation (HSCT) Program
Principal Investigators
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Timothy Olson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Leahy AB, Li Y, Talano JA, Elgarten CW, Seif AE, Wang Y, Johnson B, Monos DS, Kadauke S, Olson TS, Freedman J, Wray L, Grupp SA, Bunin N. Unrelated donor alpha/beta T cell- and B cell-depleted HSCT for the treatment of pediatric acute leukemia. Blood Adv. 2022 Feb 22;6(4):1175-1185. doi: 10.1182/bloodadvances.2021005492.
Other Identifiers
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BT13BTθ51
Identifier Type: OTHER
Identifier Source: secondary_id
13-010495
Identifier Type: -
Identifier Source: org_study_id
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