Bendamustine Bridge to Autologous or Allogeneic Transplant for Relapsed/Refractory Lymphoma
- Registration Number
- NCT02059239
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
This clinical trial is for men and women with whose lymphoma (non-Hodgkin or Hodgkin) did not respond to treatment or has returned after responding to previous therapy, and who are in need of a stem cell transplant.
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- Detailed Description
Subjects with Hodgkin's or Non-Hodgkin's lymphoma that did not respond to treatment or have disease that has returned after responding to previous treatment, and are in need of a stem cell transplant will be eligible for this pilot study. Thirty subjects will be enrolled, with 15 subjects assigned to the autologous transplant cohort (according to disease sta...
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
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must have histologically or cytologically confirmed relapsed or primary refractory lymphoma (including Hodgkin's Lymphoma) staged with Positron Emission Tomography (PET) scan to have
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Allogeneic arm:
- Progressive disease or
- No response to salvage therapy or
- Partial response to salvage therapy defined as > 50% reduction in bidirectional area of masses but standardized uptake value (SUV) remains ≥8 in at least some PET avid areas
- Prior autologous transplant
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Autologous arm:
- Partial response of >50% reduction in bidirectional area of masses and SUV reduction to <8 in PET avid areas Subjects must have evaluable disease.
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Subjects must have received at least one induction therapy and one line of salvage therapy that each incorporate at least two drugs that are standard of care for lymphoma
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Age >18 years.
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Karnofsky Performance Score (KPS) ≥ 50%
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For autologous transplants: Subjects must have an adequate number of CD34+ stem cells collected to allow for transplantation. This number is defined as ≥ 2x106 CD34+ cells / kg body weight. If not previously collected and stored, the subject must be willing to undergo stem cell mobilization and collection as per standard practice. If sufficient cells cannot be collected, subjects will be offered the option to proceed with the allogeneic arm of the study.
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Male and female subjects must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Female subjects of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
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Ability to understand and the willingness to sign a written informed consent document.
- Known to be positive for HIV
- Subjects may not be receiving any other investigational agents (defined as non FDA-approved agents) at the time of initiating bendamustine regimen. However, the salvage therapy for lymphoma can be part of an ongoing clinical trial with an investigational agent.
- Women who are pregnant or breast feeding. Women of childbearing age must use adequate contraception and have a negative pregnancy test.
- The risks to an unborn fetus or potential risks in nursing infants are unknown.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any medications listed in the protocol.
- Subject with severely decreased Left Ventricular Ejection Fraction (LVEF) or severely impaired pulmonary function tests (PFT's)
- Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemo plus Autologous Transplantation Autologous Stem Cell Transplantation Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Chemo plus Allogeneic Transplantation Allogeneic Stem Cell Transplantation Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Chemo plus Autologous Transplantation Bendamustine Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Chemo plus Autologous Transplantation Carmustine Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Chemo plus Autologous Transplantation Etoposide Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Chemo plus Autologous Transplantation Melphalan Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Chemo plus Autologous Transplantation Cytarabine Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Chemo plus Autologous Transplantation Alemtuzumab Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Chemo plus Autologous Transplantation Rituximab Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Chemo plus Allogeneic Transplantation Bendamustine Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Chemo plus Allogeneic Transplantation Etoposide Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Chemo plus Allogeneic Transplantation Cytarabine Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Chemo plus Allogeneic Transplantation Carmustine Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Chemo plus Allogeneic Transplantation Melphalan Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Chemo plus Allogeneic Transplantation Rituximab Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Chemo plus Allogeneic Transplantation Alemtuzumab Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant
- Primary Outcome Measures
Name Time Method Number of Patients Able to Proceed to Transplant 14 days after bendamustine treatment Number of patients in each arm able to proceed to stem cell transplantation within 14 days of receiving bendamustine treatment
Number of Patients Achieving Neutrophil Engraftment 35 Days Post-Transplant Proportion of patients who successfully achieve neutrophil engraftment after stem cell transplant, defined as an absolute neutrophil count of 500/mm3 or for three consecutive days.
Number of Patients Achieving Platelet Engraftment 74 Days Post-Transplant Proportion of patients who successfully achieve platelet engraftment after stem cell transplant, defined as a platelet count of \>20k/microL for three consecutive days without transfusion support for seven consecutive days.
- Secondary Outcome Measures
Name Time Method Transplant-Related Mortality From Day 0 until time of death, up to 100 days post-transplant. Death due to any cause other than disease progression within first 100 days post-transplant.
Overall Survival at Day 100 Post-Transplant From Day 0 until time of death, assessed up to 100 days post-transplant The time from stem cell infusion (Day 0) to death from any cause.
Disease Response Following Salvage Chemotherapy Within 14 days of salvage chemotherapy treatment Proportion of patients achieving a complete remission (CR; disappearance of clinically overt disease with no FDG-avid lesions on PET scan), partial remission (PR; reduction in clinical disease buden and \>50% bi-dimensional decrease in tumor size on imaging), stable disease (SD; failure to meet the criteria for CR, PR or PD with no new areas of disease invol...
Disease Response 30 Days Post-Transplant 30 days after stem cell transplant Proportion of patients achieving a complete remission (CR; disappearance of clinically overt disease with no FDG-avid lesions on PET scan), partial remission (PR; reduction in clinical disease buden and \>50% bi-dimensional decrease in tumor size on imaging), stable disease (SD; failure to meet the criteria for CR, PR or PD with no new areas of disease invol...
Disease Response at 1 Year Post-Transplant 1 year after stem cell transplant Proportion of patients achieving a complete remission (CR; disappearance of clinically overt disease with no FDG-avid lesions on PET scan), partial remission (PR; reduction in clinical disease buden and \>50% bi-dimensional decrease in tumor size on imaging), stable disease (SD; failure to meet the criteria for CR, PR or PD with no new areas of disease invol...
Progression-Free Survival After Stem Cell Transplant Stem cell transplant (Day 0) up to 2 years post-transplant Time elapsed between stem cell transplant (Day 0) and disease progression, as defined by the Cheson Criteria (the appearance of any new lesion \>1.5cm in size or a greater than 50% increase in the diameter of a previously identified node of over 1cm in size)
Overall Survival at Day 365 Post-Transplant From Day 0 until time of death, assessed up to 365 days post-transplant The time from stem cell infusion (Day 0) to death from any cause.
Trial Locations
- Locations (1)
Weill Cornell Medical College
🇺🇸New York, New York, United States