Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01471067
Phase
PHASE1
Status
Completed

Conditions

  • Blood And Marrow Transplantation
  • Leukemia
  • Lymphoma
  • Transplantation Infection
  • Transplantation, Bone Marrow

Eligibility Criteria

Sex
ALL
Age
1 Year - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Melphalan — DRUG
    140 mg/m2 by vein on Day -2 only for Fludarabine + Melphalan group.
  • Fludarabine — DRUG
    10 mg/m2 by vein on Days -7 to -4 for Melphalan + Thiotepa + Fludarabine group, or 40 mg on Days -5 to -2 for Fludarabine + Melphalan group.
  • Mycophenolate mofetil — DRUG
    15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or by mouth twice a day from Days -3 to +100 in the absence of Graft vs Host Disease (GvHD).
  • Tacrolimus — DRUG
    Starting dose 0.03 mg/kg or 0.015 mg/kg (ideal body weight) by vein starting on Day -2 and tapered around Day +180 if no Graft vs Host Disease (GvHD) is present.
  • Cord Blood Infusion — PROCEDURE
    Cord blood infusion on Day 0. Each participant will receive cells from one unexpanded cord blood sample plus cells from a second cord blood sample that has undergone fucosylation.
  • Rituximab — DRUG
    375 mg/m\^2 by vein on Day -10 for B cell malignancy.
  • ATG — DRUG
    1.25 mg/Kg by vein on Day -4. 1.75 mg/Kg by vein on Day -3.
  • Busulfan — DRUG
    Busulfan per standard of care, test dose either as an outpatient prior to admission or as an inpatient on Day -9. Busulfan pharmacokinetics performed with test dose and the first dose on Day -7 per standard of care. Doses of Days -5 and -4 subsequently adjusted to target an AUC of 4,000 microMol.min-1.
  • Clofarabine — DRUG
    30 mg/m\^2 IV Day -7 to Day -4;
  • Total Body Irradiation (TBI) — RADIATION
    2 Gy in AM of Day -3.

Study Details

The goal of this clinical research study is to learn if it is safe and feasible to transplant changed cord blood for patients with leukemia or lymphoma. Researchers also want to learn if this can help to control the disease. The cord blood will be changed to make use of sugar that is found in small amounts in blood cells. It plays a role in signaling where in the body the transplanted cells should go to. Adding more sugars to the cord blood cells in the laboratory is designed to help the cord blood cells find their way faster to the bone marrow. This may help your blood counts to recover faster. This process is called fucosylation. Anti-thymocyte globulin (ATG) is a protein that removes immune cells that cause damage to the body. Clofarabine is designed to interfere with the growth and development of cancer cells. Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die. This chemotherapy is also designed to block your body's ability to reject the donor's bone marrow cells. Melphalan and busulfan are designed to bind to the DNA of cells, which may cause cancer cells to die. Mycophenolate mofetil (MMF) and tacrolimus are designed to block the donor cells from growing and spreading in a way that could cause graft versus host disease (GVHD -- a condition in which transplanted tissue attacks the recipient's body). This may help to prevent GVHD. Rituximab is designed to attach to cancer cells, which may cause them to die.

Key Dates

Start date
Jul 13, 2012
Status verified
Apr 2017
Primary completion
Apr 25, 2017
Completion
Apr 25, 2017

Study Design

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

Arms

  • Experimental: Fludarabine/Clofarabine/Busulfan/Rituximab/TBI
    Myeloablative Regimen: Rituxan 375 mg/m\^2 (B cell malignancy) by vein (IV) on Day -10; Busulfan AUC 4,000 IV either as an outpatient prior to admission or as an inpatient on Day -9; Clofarabine 30 mg/m\^2 IV Day -7 to Day -4; ATG 1.25 mg/Kg by vein on Day -4 and 1.75 mg/Kg by vein on Day -3; Fludarabine 10 mg/m\^2 IV on Days -7 to -4; Total Body Irradiation (TBI) 2 Gy on Day -3; with Cord Blood infusions on Day 0.
  • Experimental: Fludarabine + Melphalan
    Reduced Intensity: Fludarabine 40 mg/m\^2 IV on Days -5 to -2; Melphalan 140 mg/m\^2 IV on Day -2; ATG 1.25 mg/Kg by vein on Day -4 and 1.75 mg/Kg by vein on Day -3; with Cord Blood infusions on Day 0.

Primary Outcome Measure

Number of Participants with engraftment within 42 days [ Time Frame: 42 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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