CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 7 enrolled
Drug / intervention
CD8+ Memory T Cell Infusion +5 moredrug
Likely dose
Thiotepa 5 mg/kg/day IV for 2 days (days -6 to -5), fludarabine 25 mg/m²/day IV for 5 days (days -6 to -2), busulfan 6 mg/kg/day IV for 4 consecutive days, cyclophosphamide 60 mg/kg/day IV for 2 consecutive days, and hyperfractionated TBI (1375 cGy in 11 fractions over 4 days)AI-extracted
Key inclusion· 9
  • ✓Acute leukemia in morphologic complete remission, OR myelodysplasia with <10% blasts in marrow and no circulating blasts with Auer rods; CMML with WBC ≤10,000 cells/μL and <10% blasts
  • ✓Planned myeloablative conditioning regimen at Stanford University Medical Center
  • ✓Karnofsky or Lansky Performance Score ≥70%
  • ✓HLA-matched related donor (8/8 match for HLA A, B, C, and DRB1)
Key exclusion· 8
  • ✕Prior autologous or allogeneic hematopoietic stem cell transplant
  • ✕Active CNS involvement by malignant cells
  • ✕Fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or contraindication to methotrexate
  • ✕Requirement for supplemental oxygen

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

Search/NCT04151706
NCT04151706Phase 2Completed
CompareCT.gov

CD34 Selected Allogeneic Hematopoietic Cell Transplantation With Myeloablative Conditioning and CD8+ Memory T Cell Infusion For Patients With Myelodysplastic Syndrome, Acute Leukemia, and Chronic Myelogenous Leukemia

Robert Lowsky·interventional·Posted Nov 5, 2019·Updated Oct 17, 2024

In Brief

A Phase 2 clinical trial evaluating CD8+ Memory T Cell Infusion, Thiotepa, and 4 other interventions for Acute Myeloid Leukemia and 4 related conditions. Completed, enrolled 7 participants across 1 site.

Detailed Summary

This study will evaluate combining stem cells from the patient's matched sibling donor (a standard CD34-selected transplant) with a second infusion of white blood cells called "CD8 memory T-cells" from their sibling donor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Acute Leukemia, Chronic Myeloid Leukemia
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 5, 2019
Enrollment StartFeb 27, 2020
Primary CompletionSep 8, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.7 years ago

Interventions

CD8+ Memory T Cell Infusiondrug

Allogeneic phenotypic CD8+ memory T cells from HLA matched donors infused at the time of hematopoietic cell transplantation

Thiotepadrug

5 mg/kg/day: IV for 2 consecutive days (days -6 to -5)

Fludarabinedrug

25 mg/m2/day: IV for 5 consecutive days (days -6 to -2)

Hyperfractionated TBIradiation

Administered in 11 fractions of 125 cGy over 4 days (Total dose of 1375 cGy)

Busulfandrug

6 mg/kg/dose Q24h IV. Infused over 3 hours. 1 dose per day x 4 consecutive days x 3.6 mg/kg/dose = 14.4 mg/kg

Cyclophosphamidedrug

60 mg/kg/dose Q24h IV. Infused over 2 hours. 1 dose per day x 2 consecutive days x 60 mg/kg/dose = 120 mg/kg