CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 120 target
Drug / intervention
Thiotepa +14 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓ALL in first or subsequent morphological remission (<5% marrow blasts)
  • ✓AML in first or subsequent morphological remission (<5% marrow blasts)
  • ✓Other acute leukemia or related neoplasm in first or subsequent morphological remission (<5% marrow blasts)
  • ✓MDS with history of excess blasts (≥5%) and cytoreductive therapy within past 3 months
Key exclusion· 18
  • ✕CNS involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation
  • ✕Concurrent enrollment on other experimental GVHD prevention protocols
  • ✕Weight ≥110 kg with HLA-matched related donor
  • ✕Weight ≥110 kg with HLA-matched unrelated donor (or ≥90 kg requires PI discussion)

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

Search/NCT03970096
NCT03970096Phase 2RecruitingHigh MomentumUpdated 3mo ago
Long Recruiting
CompareCT.gov

A Phase II Randomized Controlled Trial Comparing GVHD-Reduction Strategies for Allogeneic Peripheral Blood Transplantation (PBSCT) for Patients With Acute Leukemia or Myelodysplastic Syndrome: Selective Depletion of CD45RA+ Naïve T Cells (TND) vs. Post-Transplantation Cyclophosphamide (PTCy)

Fred Hutchinson Cancer Center·interventional·Posted May 31, 2019·Updated Mar 12, 2026

In Brief

A Phase 2 clinical trial evaluating Total-Body Irradiation, Thiotepa, and 13 other interventions for Acute Leukemia and 4 related conditions. Currently recruiting, targeting 120 participants across 3 sites.

Signals

Enrolling ahead of pace

Detailed Summary

This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2Recruiting
20202021202220232024202520262027202820292030
First PostedMay 31, 2019
Enrollment StartNov 19, 2019
Primary CompletionDec 31, 2027
Study CompletionDec 31, 2029
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 7.1 years agoPrimary completion in 1.5 years

Interventions

Total-Body Irradiationradiation

Undergo TBI

Thiotepadrug

Given IV

Fludarabinedrug

Given IV

Tacrolimusdrug

Given IV

Allogeneic CD34+-enriched and CD45RA-depleted PBSCsbiological

Given IV

Methotrexatedrug

Given IV

Cyclophosphamidedrug

Given IV

Peripheral Blood Stem Cellbiological

Given IV

Cyclosporinedrug

Given IV

Sirolimusdrug

Given IV

Busulfandrug

Given IV

Bone Marrow Aspiration and Biopsyprocedure

Undergo bone marrow aspiration/biopsy

Echocardiographyprocedure

Undergo ECHO

Multigated Acquisition Scanprocedure

Undergo MUGA

Biospecimen Collectionprocedure

Undergo blood sample collection