CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 68 target
Drug / intervention
Thiotepa +12 moredrug
Likely dose
Not stated in record
Key inclusion· 18
  • ✓ALL with <5% marrow blasts
  • ✓AML with <25% marrow blasts
  • ✓Other acute leukemias or related neoplasms (ABL, ALAL, MPAL, BPDCN, AUL, lymphoblastic lymphoma, Burkitt leukemia/lymphoma, mast cell leukemia, CML blast crisis, or other myeloproliferative neoplasm) with <5% marrow blasts
  • ✓MDS with excess blasts (EB-1 and EB-2) that has received cytotoxic induction chemotherapy
Key exclusion· 11
  • ✕Active CNS disease (history allowed if cleared by end of pre-conditioning evaluation)
  • ✕On other experimental GVHD prevention protocols
  • ✕Body weight >100 kg if MRD, or >75 kg if MUD (requires PI discussion)
  • ✕HIV-positive

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03779854
NCT03779854Phase 2RecruitingOn Track
Long Recruiting
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Multi-Center Phase II Randomized Controlled Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-Versus-Host Disease in Children and Young Adults

Fred Hutchinson Cancer Center·interventional·Posted Dec 19, 2018·Updated May 14, 2026

In Brief

A Phase 2 clinical trial evaluating Total-Body Irradiation, Thiotepa, and 11 other interventions for Acute Biphenotypic Leukemia and 16 related conditions. Currently recruiting, targeting 68 participants across 10 sites.

Detailed Summary

This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Biphenotypic Leukemia, Acute Leukemia, Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia, Acute Undifferentiated Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Blastic Plasmacytoid Dendritic Cell Neoplasm, Blasts Under 25 Percent of Bone Marrow Nucleated Cells, Blasts Under 5 Percent of Bone Marrow Nucleated Cells, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome With Excess Blasts-1, Myelodysplastic Syndrome/Acute Myeloid Leukemia, Burkitt Leukemia, Chronic Monocytic Leukemia, Lymphoblastic Lymphoma, Mast Cell Leukemia, Myeloproliferative Neoplasm
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2Recruiting
20192020202120222023202420252026202720282029
First PostedDec 19, 2018
Enrollment StartAug 29, 2019
Primary CompletionDec 31, 2028
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 7.5 years agoPrimary completion in 2.5 years

Interventions

Total-Body Irradiationradiation

Undergo TBI

Thiotepadrug

Given IV

Fludarabinedrug

Given IV

Cyclophosphamidedrug

Given IV

Busulfandrug

Given IV

Allogeneic Bone Marrow Transplantationprocedure

Receive unmanipulated T cell replete BM

Tacrolimusdrug

Given IV

Methotrexatedrug

Given IV

Naive T Cell-Depleted Hematopoietic Stem Cell Transplantationprocedure

Receive naive T-cell depleted PBSCs

Echocardiographyprocedure

Undergo ECHO

Biospecimen Collectionprocedure

Undergo CSF and blood sample collection

Bone Marrow Aspirationprocedure

Undergo bone marrow aspiration

Bone Marrow Biopsyprocedure

Undergo bone marrow biopsy