Non-Myeloablative Allogeneic Stem Cell Transplantation

Completed · Not applicable

Conditions studied: Lymphoma

In brief

1. To determine the safety and efficacy of non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for patients with advanced or recurrent mantle cell lymphoma. 2. To determine factors associated with response and durable remission in patients receiving rituximab, cyclophosphamide, and fludarabine in preparation for allogeneic stem cell transplantation.

Key facts

Study ID

NCT00525876

Run by

M.D. Anderson Cancer Center

People needed

49

Starts

2005-01-01

Expected to finish

2010-09-01

Last updated by the study team

2011-12-07

Who can join

Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients can be as old as 70 years.
• They must have a diagnosis of MCL, either (1) Recurrent, (2) Newly diagnosed (after cytoreduction with conventional chemotherapy) but with high-risk features (blastic or blastoid features, leukemic phase, or elevated B\^2 microglobulin (> 3).
• Patients that have received prior conventional chemotherapy but have not achieved complete response (CR).
• Disease must be chemosensitive, (ie, patients must not have had a partial response to prior therapy).
• Patients whose disease failed to respond to a previous autologous transplantation may also be eligible.
• Patients must have a matched or 1 antigen mismatched sibling or unrelated donor.
• Point Scale (PS) </= 2.
• Inclusion criteria for Immunomodulation Post transplantation: Patients can be as old as 70 years. Patients must have a diagnosis of MCL or CLL with one of the following characteristics: 1. Patients who develop disease progression or do not experience a CR within 3 months post-allogeneic transplantation 2. Patients with a weak chimerism (any mixed chimerism of donor T cells in patients receiving Campath by day 90, and less than 20% for patients not receiving Campath) or a drop of 20% or more with an amount of donor cells present in the blood < 50% by PCR .
• Continued from Inclusion # 8: Patients must have the same donor of the original transplant willing to donate lymphocytes. 4. PS </ 2.

You may not qualify if…

• Past history of anaphylaxis following exposure to rat- or mouse-derived CDR-grafted humanized monoclonal antibodies.
• Less than 4 weeks since prior chemotherapy counted from first day of treatment regimen.
• Pregnancy or lactation.
• HIV or HTLV-I positivity.
• Serum creatinine concentration > 1.6 mg/dl or serum bilirubin > 2.0 mg/dl unless due to tumor
• pulmonary function test - carbon monoxide diffusing capacity < 40%
• cardiac ejection fraction < 40% of predicted levels (by multiple-gated acquisition or echocardiography).
• Severe concomitant medical or psychiatric illness.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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