Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Basic Trial Information
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and methotrexate after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.
Further Study Information
OUTLINE: This is a multicenter study.
Peripheral blood and bone marrow aspirate samples may be collected periodically for correlative laboratory studies.
Patients are followed up periodically for a maximum of 5 years from study entry.
1. Diagnosis of B-cell chronic lymphocytic leukemia or B-cell small lymphocytic lymphoma.
Diagnosis should be according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria
1. Early Disease Cohort - Patients in the early disease cohort must include one or more of the following:
The duration of the first progression is not specified.
2. Advanced Disease Cohort - Patients in the advanced disease cohort must include one or more of the following:
2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
3. Age Requirement - Patients must be between ≥ 18 and < 70 years of age
4. Cytotoxic Chemotherapy or Alemtuzamab - There must be at least 4 weeks after day 1 of the last cycle of cytotoxic chemotherapy, or alemtuzamab.
5. Human Immunodeficiency Virus (HIV) Status - Patients must have no HIV infection.
Allogeneic transplantation in the HIV patient population is not well-defined and there are likely to be requirements for concomitant anti-HIV therapy and anti-GVHD therapy that would create potentially dangerous pharmacokinetic interactions among the different agents that could constrain therapeutic options for controlling both HIV and GVHD.
6. Hepatitis B and C - Patients must have no Hepatitis B sAg, anti-HBc or HCV.
7. Diffusion capacity of carbon monoxide DLCO must be ≥ 40% predicted
8. Left ventricular ejection fraction (LVEF) by Echocardiogram (ECHO) or Multiple gated acquisition (MUGA) must be ≥ 30%
9. Diabetes or Serious Infection - Patients must have no uncontrolled diabetes mellitus or active uncontrolled serious infections
10. Pregnancy and Nursing Status - Patients must be non-pregnant and non-nursing. Treatment under this protocol would expose a fetus to significant risks. Women of childbearing potential should have a negative pregnancy test prior to study entry.
Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (Norplant®), or double barrier method (diaphragm plus condom).
11. Richter's Transformation - Patients must have no history of Richter's transformation.
12. Initial Required Laboratory Values:
1. Donors may be either a 6/6 HLA-matched related donor by low-resolution typing at HLA A, B, DR.
2. Donors may be an 8/8 HLA-matched unrelated donor at HLA A, B, C, DR. Unrelated donors will be analyzed by molecular typing at both HLA Class I and Class II (A, B, C, DR loci).
3. Syngeneic donors are not eligible
4. Donors must be healthy and must be an acceptable donor as per institutional standards for stem cell donation.
5. There will be no donor age restriction.
Trial Contact Information
Trial Lead Organizations/Sponsors
Alliance for Clinical Trials in Oncology
Edwin P. Alyea, Study Chair
Cancer and Leukemia Group B
Edwin P. Alyea
Link to the current ClinicalTrials.gov record.
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.