Fludarabine, Bendamustine, and Rituximab in Treating Participants With Lymphoid Cancers Undergoin… (NCT00880815) | Clinical Trial Compass
CompletedPhase 1
Fludarabine, Bendamustine, and Rituximab in Treating Participants With Lymphoid Cancers Undergoing Stem Cell Transplant
United States60 participantsStarted 2009-02-17
Plain-language summary
This phase I trial studies the best dose and how well bendamustine works with standard chemotherapy (fludarabine, rituximab) in treating participants with lymphoid cancers undergoing stem cell transplant. Drugs used in chemotherapy, such as fludarabine, bendamustine, and rituximab, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant, they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes, the transplanted cells from a donor can make an immune response against the body's normal cells called graft versus host disease. Giving rituximab and methotrexate after the transplant may stop this from happening.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Patients with CD20 + chronic lymphocytic leukemia (CLL), marginal zone, mantle cell and follicular lymphoma or T-cell lymphoid malignancies who are eligible for allogeneic transplantation.
* Patients with relapsed diffuse large B-cell lymphoma may be included if they were not eligible for autologous transplantation.
* A fully-matched sibling donor or matched unrelated donor.
* Left ventricular ejection fraction (EF) \> 40% with no uncontrolled arrhythmias or symptomatic heart disease.
* Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) \> 40%.
* Serum creatinine \< 1.6 mg/dL.
* Serum bilirubin \< 3 X upper limit of normal.
* Serum glutamate pyruvate transaminase (SGPT) \< 3 X upper limit of normal.
* Voluntary signed, written Institutional Review Board (IRB)-approved informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
* Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of th…