onmyeloablative Conditioning with Pre- and Post-Transplant Rituximab followed by Related or Unrelated Donor Hematopoietic Cell Transplantation for Patients with Advanced Chronic Lymphocytic Leukemia: A Multi-Center Trial - ND

FRED HUTCHINSON CANCER RESEARCH CENTER UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE SEATTLE CHILDRE0 个研究点目标入组 40 人开始时间: 2009年12月28日最近更新: 2012年3月19日

试验速览

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•1.Patients with a diagnosis of CLL (or small lymphocytic lymphoma) or Diagnosis of CLL that progresses to prolymphocytic leukemia (PLL), or T-cell CLL or PLL. 2.Patients with B-Cell CLL or PLL who: a. Failed to meet NCI Working Group criteria2 (Appendix I) for complete or partial response after therapy with regimens containing fludarabine (or another nucleoside analog, e.g. 2-CDA, pentostatin) or with disease relapse within 12 months after completing therapy with fludarabine (or another nucleoside analog) containing regimen. b. Failed FCR or PCR combination chemotherapy at any time point. c. Patients with novo or acquired 17p deletion cytogenetic abnormality. Patients should have received induction chemotherapy but could be transplanted in 1st CR. 3.Patients who have suitable HLA-matched related or unrelated donors willing to receive G-CSF, undergo leukopharesis to collect PBMC, and to donate stem cells.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Infection with HIV. 2. Active diagnosis of CNS involvement with CLL. For LP requirement, see Appendix O. 3. Patients unwilling to use contraceptive techniques before and for 12 months after HCT 4. Pregnant women or females who are breastfeeding. 5. The addition of cytotoxic agents for cytoreduction with the exception of tyrosine kinase inhibitors (such as imatinib mesylate), cytokine therapy, hydroxyurea, low dose cytarabine, chlorambucil, or rituxan will not be allowed within three weeks of the initiation of conditioning. 6. Performance status: Karnofsky score < 60 (see Appendix B) for adult patients Lansky Play-Performance Score < 40 (Appendix C) for pediatric patients.

发起方

FRED HUTCHINSON CANCER RESEARCH CENTER UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE SEATTLE CHILDRE