Infusion of Expanded Cord Blood T Cells

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00972101
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Total Body Irradiation (TBI) — RADIATION
    3 Gy of radiation on Days -7,-6, -5 and -4.
  • Melphalan — DRUG
    140 mg/m\^2 by vein over 30 minutes as a single dose on Day -8
  • Thiotepa — DRUG
    10 mg/kg by vein over 4 hours as a single dose on Day -7
  • Fludarabine — DRUG
    40 mg/m\^2 by vein over about 30 minutes 1 time each day on Days -6 through -3.
  • Rituximab — DRUG
    Regimen 1: 375 mg/m\^2 may be given by vein over 4 - 6 hours on Day -9 if needed Regimen 2: 375 mg/m\^2 may be given by vein over 4 - 6 hours on Day -8 if needed
  • Etoposide — DRUG
    60 mg/m\^2 by vein over 1-2 hours as a single dose on Day -3.
  • Anti-thymocyte globulin (ATG) — DRUG
    Regimen 1: 1.25 and 1.75 mg/kg by vein over 4-6 hours on the Days -4 and -3. Regimen 2: 0.5, 1.0 and 1.5 mg/kg by vein over 4-6 hours on respective Days -3, -2, and -1.
  • Mycophenolate Mofetil (MMF) — DRUG
    15 mg/kg pills twice a day starting on day -3, and continued until Day 100+ after transplant (1 gram may be given by vein if necessary).
  • Tacrolimus — DRUG
    0.03 mg/kg by vein Day -2 as 24 hour continuous infusion for several weeks. After stem cell transplant, tacrolimus given by mouth 2 times a day for up to 6 months.
  • Cord Blood Infusion — PROCEDURE
    Cord blood infusion of larger portion through vein using Central Venous Catheter (CVC) on Day 0.
  • G-CSF — DRUG
    5 mcg/kg day subcutaneously (may round up to the next vial) beginning on day +1 and continuing till absolute neutrophil count is \> 2.5 x 10e\^9/L.
  • Ex vivo expanded T cell Infusion — PROCEDURE
    Infusion by vein of treated cord blood beginning dose of 1 x 10e\^5 T cells/kg on Day 14+.

Study Details

The goal of this clinical research study is to learn if treating umbilical cord blood with growth factors before a transplant can help to improve the body's ability to accept the cord blood transplants.

Key Dates

Start date
Sep 30, 2009
Status verified
Oct 2012
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen 1: No TBI
    High Dose Chemotherapy without Total Body Irradiation (TBI)
  • Experimental: Regimen 2: TBI
    High Dose Chemotherapy with Total Body Irradiation (TBI)

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Days 14 to 100 ]

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