Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Indolent Lymphoid Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00473551
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375 mg/m\^2 intravenously over several hours on Day -13, followed by 1000 mg/m\^2 intravenously on Days -6, 1, and 8.
  • Cyclophosphamide — DRUG
    50 mg/kg intravenously over two hours on Day -6, immediately following Fludarabine.
  • Fludarabine — DRUG
    40 mg/m\^2 intravenously over 30 minutes once per day for 4 days, starting Day -6.
  • Mesna — DRUG
    10 mg/kg continuous intravenous infusion for 4 hours for total of 6 doses (24 hours) following Cyclophosphamide.
  • Radiation Treatment — RADIATION
    2Gy Total body radiation day before transplantation
  • Stem Cell Transplantation (SCT) — PROCEDURE
    Allo CD34+ Selected SCT/Infusion of stem cells.
  • Sirolimus — DRUG
    6 mg by mouth on day -2 followed by 2 mg daily from day -1 through day +7.
  • Anti-third Party Cytolytic T-lymphocytes (CTL) — PROCEDURE
    Intravenous infusion of anti-third party CTL.

Study Details

Primary Objective: 1\. To determine the maximally tolerated dose of anti-third party cytolytic T-lymphocytes, defined as the dose which achieve engraftment without severe GVHD (graft-vs-host disease) at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells. Secondary Objective: 1\. Toxicity, response rate, time to progression and overall survival.

Key Dates

Start date
May 31, 2007
Status verified
Dec 2011
Primary completion
Nov 30, 2009
Completion
Nov 30, 2009

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anti-Third Party T Lymphocytes + Nonmyeloablative SCT
    Anti-Third Party CTL (Cytolytic T-lymphocytes) with Nonmyeloablative SCT (Stem Cell Transplantation) Rituximab 375 mg/m\^2 intravenously over several hours on Day -13, followed by 1000 mg/m\^2 intravenously on Days -6, 1, and 8; + Cyclophosphamide 50 mg/kg intravenously over two hours on Day -6, immediately following Fludarabine; + Fludarabine 40 mg/m\^2 intravenously over 30 minutes once per day for 4 days, starting Day -6; + Radiation 2Gy Total body radiation day before transplantation + Stem Cell Transplantation + Intravenous infusion of Anti-third Party CTLs.

Primary Outcome Measure

Number of Participants achieving engraftment without severe Graft-versus-host disease (GVHD) [ Time Frame: Baseline to 90 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
U.T.M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)Multiple myeloma
By specialty
OncologyBlood cancer
By research site
U.T.M.D. Anderson Cancer Center· Houston, TX

Related Studies