IRB #

IRB00006928

Title

CALGB 100701/BMT CTN 0804: Phase II Study of Reduced-Intensity Allogeneic Stem Cell Transplant for High-Risk Chronic Lymphocytic Leukemia (CLL)

Principal Investigator

Richard Maziarz

Study Purpose

The purpose of this study is to find out the effects that a reduced-intensity allogeneic transplant has on people with chronic lymphocytic leukemia. The study doctor will recommend one of two treatment chemotherapy options: 1) Fludarabine, Busulfan, and Rituximab or 2) Fludarabine, Cyclophosphamide, rATG (MUD only), and Rituximab. The first chemotherapy preparative regimen will then have one of two GVHD prophylaxis regimens: A)Tacrolimus, Sirolimus, Methotrexate or B)Tacrolimus, Methotrexate. The second preparative regiment will recieve GVHD prophylaxis Tacrolimus and Methotrexate. Both preparative regimens will have Rituximab maintenance therapy.

Medical Condition(s)

Lymphoid Leukemia

Eligibility Criteria

- Diagnosis of B-CLL or B-SLL according to IWCLL 2008 Criteria.
- ECOG performance status 0-2.
- ≥ 18 and < 70 years.
- At least 4 weeks after last cycle of cytotoxic chemotherapy, or alemtuzumab.
- No HIV infection.
- No Hepatitis B sAg, anti-HBc or HCV.
- DLCO ≥ 40% predicted.
- LVEF by ECHO or MUGA ≥ 30%.
- No uncontrolled diabetes mellitus or active uncontrolled serious infections.
- Non-pregnant and non-nursing.
- Serum Creatinine < 2 mg/dL calculated; Creatinine Clearance ≥ 40 mL/min.
- AST < 3 x ULN.
- Total Bilirubin < 2 mg/dL (except for Gilbert's syndrome).
- Specific requirements to define early versus advanced disease cohort

Age Range

18 - 70

Healthy Volunteers Needed

Yes

Duration of Participation

5-6 days or up to 5 years

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Cancer and Leukemia Group B

Recruitment End

Compensation Provided

No