Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03615105
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Hyperfractionated total body irradiation — RADIATION
    Hyperfractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1,375 or 1,500 cGy) over 4 days (days -9 through -6).
  • Thiotepa — DRUG
    Thiotepa 5 mg/kg IV
  • Cyclophosphamide — DRUG
    Cyclophosphamide 60 mg/kg IV
  • Busulfan — DRUG
    Busulfan (adult/ped dose)
  • Fludarabine — DRUG
    Fludarabine 25 mg/m2 IV
  • Melphalan — DRUG
    Melphalan 70 mg/m2 IV
  • Clofarabine — DRUG
    Clofarabine 20-30 mg/m2 IV
  • HPC(A) stem cell allograft — PROCEDURE
    All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
  • Rituximab — DRUG
    Rituximab 200 mg IV flat dose
  • Rabbit antithymocyte globulin — DEVICE
    Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.

Study Details

This study is being done to learn whether a new method to prevent rejection between the donor immune system and the patient's body is effective.

Key Dates

Start date
Jul 25, 2018
Status verified
Mar 2024
Primary completion
Mar 6, 2024
Completion
Mar 6, 2024

Study Design

Enrollment
9 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation, Thiotepa & Cyclophosphamide
  • Experimental: Busulfan, Fludarabine & Melphalan
  • Experimental: Clofarabine, Thiotepa & Melphalan

Primary Outcome Measure

the Number of Incidences of Grade 3-4 Acute GVHD [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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