Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01027000|
Recruitment Status : Active, not recruiting
First Posted : December 7, 2009
Results First Posted : May 3, 2017
Last Update Posted : February 6, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Biological: rituximab Drug: busulfan Drug: cyclophosphamide Drug: fludarabine phosphate Drug: methotrexate Drug: sirolimus Drug: tacrolimus Procedure: allogeneic stem cell transplant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Reduced-Intensity Allogeneic Stem Cell Transplant for High-Risk Chronic Lymphocytic Leukemia (CLL)|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||January 2016|
Experimental: Treatment (Combination of chemotherapy and transplant)
See detailed description
Drug: fludarabine phosphate
Procedure: allogeneic stem cell transplant
- 2-year Progression-free Survival in Early Disease Participants [ Time Frame: 2 years post-registration ]
Percentage of participants who were alive and progression free at 2 years for participants with early disease stage. The 2 year progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
A progression is defined as one of the following events:
- >= 50% increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be >= 2 cm); appearance of new palpable lymph nodes.
- >= 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly, which was not previously present.
- > 50% increase in peripheral blood lymphocytes with an absolute increase > 5000/μL.
- Transformation to a more aggressive histology (i.e., Richter's syndrome or prolymphocytic leukemia with >= 56% prolymphocytes).
- Response [ Time Frame: 5 years post-registration ]
- Acute Graft-vs-host Disease (GVHD) [ Time Frame: 5 years post-registration ]
- Chronic GVHD [ Time Frame: 5 years post-registration ]
- Treatment-related Mortality [ Time Frame: 6 months post-transplant ]
- Overall Survival [ Time Frame: 5 years post-registration ]
- Chimerism for CD3 [ Time Frame: 5 years post-registration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027000
|Study Chair:||Edwin P. Alyea, MD||Dana-Farber Cancer Institute|