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CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS, AL and CML

NCT04151706 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-10-17

Study results available
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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.

Conditions

Interventions

DRUG

CD8+ Memory T Cell Infusion

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

DRUG

Thiotepa

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

DRUG

Fludarabine

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

RADIATION

Hyperfractionated TBI

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

DRUG

Busulfan

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

DRUG

Cyclophosphamide

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Robert Lowsky

    lead OTHER

Principal Investigators

  • Robert Lowsky, MD · Stanford Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-27
Primary Completion
2023-09-08
Completion
2023-09-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04151706 on ClinicalTrials.gov