Natural Killer (NK) Cell Adback After Allogeneic Stem Cell Transplant With Campath-IH Plus Chemorx for Patients With Lymphoid Malignancies
|ClinicalTrials.gov Identifier: NCT00536978|
Recruitment Status : Completed
First Posted : September 28, 2007
Results First Posted : May 22, 2012
Last Update Posted : May 22, 2012
- 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.
- To determine the efficacy (disease-free-survival) of this strategy.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Leukemia||Drug: ARA-C Drug: BCNU Drug: Campath-1H Drug: Cyclophosphamide Drug: Etoposide Drug: Fludarabine Drug: Melphalan Drug: Rituximab Other: Allogeneic Stem Cell Transplantation Radiation: Total body radiation (TBI) Drug: Methotrexate Drug: Tacrolimus Procedure: Adback NK or T Cell||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||T-Cell or Natural Killer (NK) Cell Adback in Patients With Lymphoid Malignancies Receiving Allogeneic Stem Cell Transplantation With Campath-IH Containing Conditioning Regimens|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
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)].
100 mg/m^2 IV Daily Over 1 Hour for 4 Days
Other Names:Drug: BCNU
300 mg/m^2 IV Over 1 Hour for 1 Day
Other Names:Drug: Campath-1H
15 mg IV Daily Over 30 Minutes for 3 Days
Other Names:Drug: Cyclophosphamide
1000 mg/m^2 IV Daily Over 1 Hour for 3 Days
Other Names:Drug: Etoposide
100 mg/m^2 IV Daily Over 3 Hours for 4 Days
Other Name: VePesidDrug: Fludarabine
30 mg/m^2 IV Daily Over 1 Hour for 3 Days
Other Names:Drug: Melphalan
100 mg/m^2 IV Over 30 Minutes for 1 Day.Drug: 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.
Other Name: RituxanOther: Allogeneic Stem Cell Transplantation
Stem Cell Infusion on Day 0.Radiation: Total body radiation (TBI)
TBI on Day 5 following chemotherapy, before stem cell infusion.Drug: Methotrexate
5 mg/m2 IV on Days +1, +3, and +6.Drug: Tacrolimus
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.
Other Name: PrografProcedure: Adback NK or T Cell
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.
- 6-month Treatment Related Mortality (TRM) [ Time Frame: 6 Months ]Number of participant deaths in 6 months of T- cell or Natural killer (NK) cell adback treatment.
- One-year Disease-free Survival (DFS) [ Time Frame: 1 Year ]Efficacy (disease-free-survival) defined as number of participants still living, without disease progression following T- cell or Natural killer (NK) cell adback. One-year disease-free survival (DFS) time estimated using the Kaplan-Meier estimator. Patients who experience disease recurrence considered to be a treatment failure event.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536978
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Issa F. Khouri, MD||M.D. Anderson Cancer Center|