2012-02-28
2015-05-28
2019-08-29
94
NCT01529827
Roswell Park Cancer Institute
Roswell Park Cancer Institute
INTERVENTIONAL
Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic malignancies. Giving chemotherapy drugs such as fludarabine phosphate and melphalan, and low-dose TBI before a donor PBSCT helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from the donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cell from a donor can make an immune response against the body's normal cells. Giving tacrolimus, mycophenolate mofetil (MMF), and methotrexate after transplant may stop this from happening
PRIMARY OBJECTIVES: I. To determine the transplant related mortality (TRM) of this reduced-intensity transplantation (RIT) combination, fludarabine (fludarabine phosphate), melphalan, and TBI in a patient population usually not eligible for a full a myeloablative allogeneic hematopoietic stem cell transplantation (HSCT). SECONDARY OBJECTIVES: I. To evaluate clinical response, progression free survival (PFS) at one year, engraftment rate, and graft-versus-host disease (GvHD) incidence with the proposed RIT regimen across a variety of hematological conditions. II. Correlative studies will include chimerism analysis by molecular analysis and evaluation of immune reconstitution by cytomegalovirus (CMV) dextramer analysis using flow cytometry. OUTLINE: PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI twice daily (BID) on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or orally (PO) BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15-30 minutes on days 1, 3, and 6. After completion of study treatment, patients are followed up periodically.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2012-02-06 | 2017-06-30 | 2019-09-16 |
2012-02-08 | 2017-06-30 | 2019-09-24 |
2012-02-09 | 2017-07-02 | 2019-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Treatment (reduced intensity allogeneic PBSCT) PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROP | DRUG: fludarabine phosphate
DRUG: melphalan
RADIATION: total-body irradiation
DRUG: tacrolimus
DRUG: mycophenolate mofetil
DRUG: methotrexate
OTHER: laboratory biomarker analysis
PROCEDURE: allogeneic hematopoietic stem cell transplantation
PROCEDURE: peripheral blood stem cell transplantation
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Transplant Related Mortality (TRM) | Day 100 transplant related mortality (TRM). An exact 95% confidence interval will be provided. | In the first 100 days from day 0 of transplant |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Clinical Response | Patients will be followed according to response criteria as referenced in BMT SOP "Standards of Therapy" last updated 2008. Clinical Response = CR + PR. Complete Response Requires all of the following: * Serum and urine negative for monoclonal proteins by immunofixation * Normal free light chain ratio * Plasma cells in marrow < 5% Partial Response (PR) Requires any of the following: - ≥ 50% reduction in current serum monoclonal protein levels > 0.5 g/dL or urine light chain levels > 100 mg/day with a visible peak or free light chain levels > 10mg/dL Progressive Disease (PD) Requires any of the following: * If progressing from CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double) * If progressive from PR or SD, ≥ 50% increase in the serum M protein to > 0.5 g/dL,or ≥ 50% increase in urine M protein to > 200mg/day with visible peak present. * Free light chain increase of ≥ 50% to | In the first 100 days from day 0 of transplant |
Progression Free Survival (PFS) at One Year | Assessed using Kaplan Meier and Proportional Hazards | day of transplant until progression up to 5 years |
Median Time to Neutrophil Engraftment | Median time to recovery of absolute neutrophil count >=500/uL for 3 consecutive days. Summarized using standard descriptive statistics along with corresponding 95% confidence intervals. | Day 100 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
3 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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