Natural Killer (NK) Cell Adback After Allogeneic Stem Cell Transplant With Campath-IH Plus Chemorx for Patients With Lymphoid Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00536978
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ARA-C — DRUG
    100 mg/m\^2 IV Daily Over 1 Hour for 4 Days
  • BCNU — DRUG
    300 mg/m\^2 IV Over 1 Hour for 1 Day
  • Campath-1H — DRUG
    15 mg IV Daily Over 30 Minutes for 3 Days
  • Cyclophosphamide — DRUG
    1000 mg/m\^2 IV Daily Over 1 Hour for 3 Days
  • Etoposide — DRUG
    100 mg/m\^2 IV Daily Over 3 Hours for 4 Days
  • Fludarabine — DRUG
    30 mg/m\^2 IV Daily Over 1 Hour for 3 Days
  • Melphalan — DRUG
    100 mg/m\^2 IV Over 30 Minutes for 1 Day.
  • Rituximab — DRUG
    375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks.
  • Allogeneic Stem Cell Transplantation — OTHER
    Stem Cell Infusion on Day 0.
  • Total body radiation (TBI) — RADIATION
    TBI on Day 5 following chemotherapy, before stem cell infusion.
  • Methotrexate — DRUG
    5 mg/m2 IV on Days +1, +3, and +6.
  • Tacrolimus — DRUG
    0.03 mg/kg/day IV starting on Day -2, to be given through day 60, tapered by 20% every week, then discontinue by day 90.
  • Adback NK or T Cell — PROCEDURE
    Adback natural killer (NK) cells or T cells after transplantation to enhance full engraftment of donor cells. Cell adback after transplantation applies only if there is no active GVHD, and no previous episode of grade II-IV GVHD.

Study Details

Primary objective: * To determine the safety of adback T- or Natural Killer (NK) cells in patients with lymphoid malignancies receiving allogeneic stem cell transplantation with Campath-IH containing conditioning regimen. Secondary objective: * To determine the efficacy (disease-free-survival) of this strategy.

Key Dates

Start date
Sep 30, 2007
Status verified
Sep 2020
Primary completion
Nov 30, 2010
Completion
Nov 30, 2010

Study Design

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

Arms

  • Experimental: NK Cell/T-Cell Infusion
    Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m\^2 IV, Etoposide 100 mg/m\^2 IV, Ara-C 100 mg/m\^2 IV Daily for 4 days and Melphalan 100 mg/m\^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks\]; or Non-myeloablative Preparative Regimen \[Fludarabine 30 mg/m\^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m\^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)\].

Primary Outcome Measure

6-month Treatment Related Mortality (TRM) [ Time Frame: 6 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

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