Safety and Efficacy of Campath in Nonmyeloablative Transplantation

Completed · Not applicable

Conditions studied: Lymphoma, Leukemia

In brief

Objective of the low-dose transplant regimen must produce the following effects: 1. Suppression of the patient's immune system to prevent rejection of the donor cells; 2. Control of the lymphoma. The pretransplant regimen must suppress the lymphoma sufficiently to prevent marked progression of the tumor and allow time for the GVT effect to occur.

Key facts

Study ID

NCT00038844

Run by

M.D. Anderson Cancer Center

People needed

65

Starts

2001-06-01

Expected to finish

2010-09-01

Last updated by the study team

2011-11-02

Who can join

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

You may qualify if…

• Up to 70 years of age (physiological).
• Any histological subtype of lymphoid malignancies (those with CD20 negative disease will not receive Rituximab).
• Patients in relapse with a partial remission or stable disease.
• Patients who failed a prior autologous transplant are also eligible.
• Patients must have a matched unrelated donor and no human leukocyte antigen (HLA) identical sibling is available. Point scale (PS)<2.
• Patients are included even if they were previously exposed to Campath or Rituximab.

You may not qualify if…

• Past history of anaphylaxis following exposure to rat- or mouse-derived COR-grafted humanized monoclonal antibodies.
• Less than 4 weeks since prior chemotherapy counted from 1st day of treatment regimen.
• Pregnancy or lactation.
• HIV or HTLV-I positively.
• Serum creatinine >1.6mg/dl or serum bilirubin >1.5mg/dl unless due to tumor.
• Pulmonary function tests (PFTs) -OLCO<50%, cardiac EF <50% of predicted levels.
• Patient with severe concomitant medical or psychiatric illness.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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