Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00472056
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Carmustine — DRUG
    300 mg/m\^2 IV for 1 Day
  • Etoposide — DRUG
    Arm 1 = 200 mg/m\^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m\^2 IV Every 12 Hours x 4 Days
  • Cytarabine — DRUG
    Arm 1 = 200 mg/m\^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m\^2 IV Every 12 Hours x 4 Days
  • Melphalan — DRUG
    140 mg/m\^2 IV x 1 Day
  • Rituximab — DRUG
    Cohort 1, High-Dose Rituximab = 1000 mg/m\^2 IV On Days +1 and +8 After Stem Cell Infusion; Cohort 2, Standard Dose Rituximab = 375 mg/m\^2 IV On Days +1 and +8 After Stem Cell Infusion.

Study Details

Cohort 1: Patients who are less than or equal to 65 years of age. 1\. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab) Cohort 2: Patients who are older than 65 years of age 1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab) 2. To determine the treatment related mortality (TRM)

Key Dates

Start date
Mar 31, 2005
Status verified
Jun 2012
Primary completion
Jun 30, 2012
Completion
Jun 30, 2012

Study Design

Enrollment
93 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BEAM + Standard Rituximab
    Arm 1 BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Rituximab with Standard Rituximab for Cohort 1 or 2 Cohort 1 for 65 years of age or younger BEAM: Carmustine 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Cohort 2 for older than 65 years of age BEAM: Carmustine 300 mg/m2 IV over 1 hour on day -6, cytarabine 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Standard Rituximab: 375 mg/m\^2 IV Days +1, +8 after Stem Cell Infusion on Day 0.
  • Experimental: BEAM + High Rituximab
    BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab Cohort 1 for 65 years of age or younger BEAM: Carmustine 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Cohort 2 for older than 65 years of age BEAM: Carmustine 300 mg/m2 IV over 1 hour on day -6, cytarabine 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. High Dose Rituximab: 1000 mg/m\^2 IV Days +1, +8 after Stem Cell Infusion on Day 0

Primary Outcome Measure

Disease-free Survival (DFS) [ Time Frame: Up to 5 years from transplant date. ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

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By research site
UT MD Anderson Cancer Center· Houston, TX

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