Antithymocyte Globulin, Clofarabine, and Rituximab in Treating Patients After an Unsuccessful Stem Cell Transplant

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT00617929
Phase
PHASE2
Status
Terminated

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

  • anti-thymocyte globulin — BIOLOGICAL
    administer 3 mg/kg intravenously (IV) over 4 hours on days -6, -5 and -4.
  • rituximab — BIOLOGICAL
    administered 375 mg/m\^2 intravenously (IV) in 1 mg/mL normal saline on day -7.
  • clofarabine — DRUG
    administered 30 mg/m\^2 intravenously (IV) over 1 hour on Days -4, -3, and -2.
  • stem cell transplantation — PROCEDURE
    administered on Day 0 per institutional guidelines.

Study Details

RATIONALE: Antithymocyte globulin, clofarabine, and rituximab may stop the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving antithymocyte globulin together with clofarabine and rituximab works in treating patients after an unsuccessful stem cell transplant.

Key Dates

Start date
Jan 31, 2008
Status verified
Dec 2017
Primary completion
Oct 31, 2014
Completion
Oct 31, 2015

Study Design

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

Arms

  • Experimental: Conditioning for Graft Failure
    Primary or secondary graft failure after hematopoietic stem cell transplantation defined as a \> 50% loss of previously best donor chimerism or less than 25% donor chimerism beyond day +42 with pancytopenia and no evidence of relapse. Patients with any diagnosis, type of donor, hematopoietic cell graft or conditioning regimen should be considered for this study. Patients receive anti-thymocyte globulin, rituximab, and clofarabine.

Primary Outcome Measure

Rate of Sustained Donor Engraftment [ Time Frame: Day 42 post transplantation ]

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center at University of MinnesotaMinneapolisMinnesota55455-

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