Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT01118013|
Recruitment Status : Terminated
First Posted : May 6, 2010
Results First Posted : March 24, 2017
Last Update Posted : March 24, 2017
RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a peripheral blood 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate, tacrolimus, and antithymocyte globulin before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with relapsed hematologic malignancies or secondary myelodysplasia previously treated with high-dose chemotherapy and autologous stem cell transplant .
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms||Biological: anti-thymocyte globulin Biological: donor lymphocytes Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: busulfan Drug: fludarabine phosphate Drug: methotrexate Drug: mycophenolate mofetil Drug: tacrolimus Other: reduced-intensity transplant conditioning procedure Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation as Second Transplantation for Patients With Disease Relapse or Myelodysplasia After Prior Autologous Transplantation|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||August 2013|
Matched-unrelated donor: Patients receive antithymocyte globulin, tacrolimus, and methotrexate as in HLA-identical donor regimen. Patients also receive oral mycophenolate mofetil twice daily on days 0 to 60.
Allogeneic Stem Cell Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim subcutaneously daily beginning on day 7 and continuing until blood counts recover.
Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks.
Blood samples are collected at baseline and then periodically during study therapy for pharmacokinetic studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for up to 5½ years.
|Biological: anti-thymocyte globulin Biological: donor lymphocytes Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: busulfan Drug: fludarabine phosphate Drug: methotrexate Drug: mycophenolate mofetil Drug: tacrolimus Other: reduced-intensity transplant conditioning procedure Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation|
- Event-free Survival (EFS) [ Time Frame: Duration of study (up to 5.5 years) ]EFS was defined as the date of transplant to date of progression or develop myelodysplasia after autologous transplant. EFS was estimated using the Kaplan Meier method.
- Comparison of EFS Distribution to That of CALGB-100002 [ Time Frame: 2 years ]EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test.
- Complete Response Rate [ Time Frame: Up to 5.5 years ]Complete response (CR) rate is reported as the percentage of participants who achieved a CR.
- Overall Survival [ Time Frame: Up to 5.5 years ]Overall survival (OS) was defined as the transplant from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.
- Rate of Opportunistic Infections [ Time Frame: 1 year post transplant ]Percent of participants who have an opportunistic (viral, bacterial and fungal) infection in the first year following transplant.
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): NCT01118013
|United States, Delaware|
|Tunnell Cancer Center at Beebe Medical Center|
|Lewes, Delaware, United States, 19958|
|CCOP - Christiana Care Health Services|
|Newark, Delaware, United States, 19713|
|United States, Florida|
|Florida Hospital Cancer Institute at Florida Hospital Orlando|
|Orlando, Florida, United States, 32803-1273|
|United States, Maryland|
|Greenebaum Cancer Center at University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|Union Hospital of Cecil County|
|Elkton MD, Maryland, United States, 21921|
|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Cancer Institute of New Jersey at Cooper - Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, New York|
|New York Weill Cornell Cancer Center at Cornell University|
|New York, New York, United States, 10021|
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210-1240|
|Principal Investigator:||Asad Bashey, MD, PhD||Blood and Marrow Transplant Group of Georgia|