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CD34+ Transplants for Leukemia and Lymphoma

NCT05565105 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-03

No results posted yet for this study

Summary

This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.

Conditions

  • Leukemia, Myeloid, Acute
  • Leukemia, Lymphocytic, Acute

Interventions

RADIATION

Total Body Irradiation (TBI)

Hyper-fractioned TBI is administered by a linear accelerator at a dose rate of \< 15 cGy/minute.

DRUG

Thiotepa

Thiotepa: 5 mg/kg/day IV over approximately 4 hours daily x 2 (Day -5 and Day -4).

DRUG

Cyclophosphamide

Cyclophosphamide: 60 mg/kg/day x 2 or Fludarabine 25 mg/m\^2 x 5 if cyclophosphamide is contraindicated

DRUG

Busulfan

Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics

DRUG

Melphalan

Melphalan: 70 mg/m\^2/day x 2

DRUG

Fludarabine

Fludarabine: 25 mg/m\^2/day x 5

Sponsors & Collaborators

  • Guenther Koehne

    lead OTHER

Principal Investigators

  • Guenther Koehne, MD, PhD · Baptist Health South Florida/Miami Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2033-06-30
Completion
2033-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05565105 on ClinicalTrials.gov