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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.
The purpose of this study is to test the safety and effectiveness of giving the drug Bendamustine, followed by high dose chemotherapy, within two weeks prior to a stem cell transplant for lymphoma that has not achieved a complete response to salvage (treatment used for relapsed disease) chemotherapy.
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 status and eligibility) and 15 subjects to the allogeneic transplant cohort (according to diseases status and eligibility).
Subjects will undergo the following a number of screening procedures to determine eligibility. All eligible subjects will receive bendamustine at a dose of 200 mg/ m2/ day for two days on Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Subjects will then receive the conditioning regimen, BEAM (carmustine, etoposide, cytarabine arabinoside, and Melphalan) and alemtuzumab for 6 days (Day -6 to Day -1) followed by an autologous or allogeneic transplant.
Subjects with pathological confirmed B-cell malignancies will also receive rituximab 375 mg/m2 on Days + 1 and +8 post-transplant. Subjects with T-cell lymphoma will be enrolled in the study but will not receive rituximab.
After the transplantation all subjects will receive medication to prevent graft vs host disease and supportive care to prevent infections. To speed up the recovery of stem cells, subjects will receive post-transplant filgrastim (G-CSF).
After discharge from the hospital, subjects will be seen regularly in the clinic for an exam and assessments. All these tests are considered standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemo plus Autologous Transplantation | Experimental | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine | Drug | Days - 24 and Day - 23 followed by a short break of 10 - 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Able to Proceed to Transplant | Number of patients in each arm able to proceed to stem cell transplantation within 14 days of receiving bendamustine treatment | 14 days after bendamustine treatment |
| Number of Patients Achieving Neutrophil Engraftment | 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. | 35 Days Post-Transplant |
| Number of Patients Achieving Platelet Engraftment | 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. | 74 Days Post-Transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at Day 100 Post-Transplant | The time from stem cell infusion (Day 0) to death from any cause. | From Day 0 until time of death, assessed up to 100 days post-transplant |
| Overall Survival at Day 365 Post-Transplant |
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Inclusion Criteria:
must have histologically or cytologically confirmed relapsed or primary refractory lymphoma (including Hodgkin's Lymphoma) staged with Positron Emission Tomography (PET) scan to have
Allogeneic arm:
Autologous arm:
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
Age >18 years.
Karnofsky Performance Score (KPS) ≥ 50%
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.
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.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsiporah Shore, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33586581 | Derived | Orfali N, Jhanwar Y, Koo C, Pasciolla M, Baldo M, Cuvilly E, Furman R, Gergis U, Greenberg J, Guarneri D, Hsu JM, Leonard JP, Mark T, Mayer S, Maignan K, Martin P, Opong A, Pearse R, Phillips A, Rossi A, Ruan J, Rutherford SC, Ryan J, Suhu G, Van Besien K, Shore T. Sequential intensive chemotherapy followed by autologous or allogeneic transplantation for refractory lymphoma. Leuk Lymphoma. 2021 Jul;62(7):1629-1638. doi: 10.1080/10428194.2021.1881516. Epub 2021 Feb 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemo Plus Autologous 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 Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2017 |
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| Carmustine | Drug | 300 mg/m2 on Day -6 |
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| Etoposide | Drug | 100 mg/m2 on days -5 to -2 |
|
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| Melphalan | Drug | 140mg/m2 on Day -1 |
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| Cytarabine | Drug | 200 mg/m2 on days -5 to -2 |
|
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| Alemtuzumab | Drug | 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors |
|
|
| Autologous Stem Cell Transplantation | Biological |
|
| Allogeneic Stem Cell Transplantation | Biological |
|
| Rituximab | Drug | Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant |
|
|
The time from stem cell infusion (Day 0) to death from any cause.
| From Day 0 until time of death, assessed up to 365 days post-transplant |
| Transplant-Related Mortality | Death due to any cause other than disease progression within first 100 days post-transplant. | From Day 0 until time of death, up to 100 days post-transplant. |
| Disease Response Following Salvage Chemotherapy | 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 involvement) or progressive disease (PD; 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), as per Cheson Criteria, following salvage chemotherapy with Bendamustine. | Within 14 days of salvage chemotherapy treatment |
| Disease Response 30 Days Post-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 involvement) or progressive disease (PD; 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), as per Cheson Criteria, 30 days following autologous or allogeneic stem cell transplant | 30 days after stem cell transplant |
| Disease Response at 1 Year Post-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 involvement) or progressive disease (PD; 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), as per Cheson Criteria, 1 year following autologous or allogeneic stem cell transplant | 1 year after stem cell transplant |
| Progression-Free Survival After Stem Cell 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) | Stem cell transplant (Day 0) up to 2 years post-transplant |
| FG001 | Chemo Plus Allogeneic 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 Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemo Plus Autologous 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 Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant |
| BG001 | Chemo Plus Allogeneic 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 Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Diagnosis | Count of Participants | Participants |
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| Lines of Prior Therapy | Number | Lines of Therapy |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Able to Proceed to Transplant | Number of patients in each arm able to proceed to stem cell transplantation within 14 days of receiving bendamustine treatment | Posted | Count of Participants | Participants | 14 days after bendamustine treatment |
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| Primary | Number of Patients Achieving Neutrophil Engraftment | 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. | 5 participants (2 from chemo + autologous transplant arm, 3 from chemo + allogeneic transplant arm) were unable to be analyzed for this outcome measure as they did not complete the study and did not receive an autologous or allogeneic transplant. | Posted | Count of Participants | Participants | 35 Days Post-Transplant |
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| Primary | Number of Patients Achieving Platelet Engraftment | 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. | 5 participants (2 from chemo + autologous transplant arm, 3 from chemo + allogeneic transplant arm) were unable to be analyzed for this outcome measure as they did not complete the study and did not receive an autologous or allogeneic transplant. | Posted | Count of Participants | Participants | 74 Days Post-Transplant |
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| Secondary | Overall Survival at Day 100 Post-Transplant | The time from stem cell infusion (Day 0) to death from any cause. | 5 participants (2 from chemo + autologous transplant arm, 3 from chemo + allogeneic transplant arm) were unable to be analyzed for this outcome measure as they did not complete the study and did not receive an autologous or allogeneic transplant. | Posted | Count of Participants | Participants | From Day 0 until time of death, assessed up to 100 days post-transplant |
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| Secondary | Overall Survival at Day 365 Post-Transplant | The time from stem cell infusion (Day 0) to death from any cause. | 5 participants (2 from chemo + autologous transplant arm, 3 from chemo + allogeneic transplant arm) were unable to be analyzed for this outcome measure as they did not complete the study and did not receive an autologous or allogeneic transplant. | Posted | Count of Participants | Participants | From Day 0 until time of death, assessed up to 365 days post-transplant |
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| Secondary | Transplant-Related Mortality | Death due to any cause other than disease progression within first 100 days post-transplant. | 5 participants (2 from chemo + autologous transplant arm, 3 from chemo + allogeneic transplant arm) were unable to be analyzed for this outcome measure as they did not complete the study and did not receive an autologous or allogeneic transplant. | Posted | Count of Participants | Participants | From Day 0 until time of death, up to 100 days post-transplant. |
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| Secondary | Disease Response Following Salvage Chemotherapy | 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 involvement) or progressive disease (PD; 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), as per Cheson Criteria, following salvage chemotherapy with Bendamustine. | Posted | Count of Participants | Participants | Within 14 days of salvage chemotherapy treatment |
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| Secondary | Disease Response 30 Days Post-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 involvement) or progressive disease (PD; 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), as per Cheson Criteria, 30 days following autologous or allogeneic stem cell transplant | 5 participants (2 from chemo + autologous transplant arm, 3 from chemo + allogeneic transplant arm) were unable to be analyzed for this outcome measure as they did not complete the study and did not receive an autologous or allogeneic transplant. | Posted | Count of Participants | Participants | 30 days after stem cell transplant |
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| Secondary | Disease Response at 1 Year Post-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 involvement) or progressive disease (PD; 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), as per Cheson Criteria, 1 year following autologous or allogeneic stem cell transplant | 5 participants (2 from chemo + autologous transplant arm, 3 from chemo + allogeneic transplant arm) were unable to be analyzed for this outcome measure as they did not complete the study and did not receive an autologous or allogeneic transplant. | Posted | Count of Participants | Participants | 1 year after stem cell transplant |
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| Secondary | Progression-Free Survival After Stem Cell 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) | 5 participants (2 from chemo + autologous transplant arm, 3 from chemo + allogeneic transplant arm) were unable to be analyzed for this outcome measure as they did not complete the study and did not receive an autologous or allogeneic transplant. | Posted | Median | 95% Confidence Interval | Months | Stem cell transplant (Day 0) up to 2 years post-transplant |
|
Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bendamustine | Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days | 0 | 34 | 2 | 34 | 9 | 34 |
| EG001 | Bendamustine Plus Autologous 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 Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant | 0 | 16 | 4 | 16 | 16 | 16 |
| EG002 | Bendamustine Plus Allogeneic 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 Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant | 7 | 13 | 10 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Heart Failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Lower Gastrointestinal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Intestinal Necrosis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Disseminated Adenovirus Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Post-Transplant Lymphoproliferative Disorder | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic Graft versus Host Disease | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Respiratory Distress | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myelodysplastic Syndrome | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Acute Myeloid Leukemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paroxysmal Atrial Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Tumor Lysis Syndrome | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Oral Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hemolysis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperbilirubinemia | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Intracranial Hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Delirium | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Acute Renal Failure | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Maculopapular Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Cytomegalovirus Viremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Epstein-Barr Virus Viremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Soft Tissue Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Lung Infection - Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Lung Infection - Viral Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Lung Infection - Fungal Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Norovirus Enterocolitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Influenza A | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Rhinovirus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection - Respiratory Syncytial Virus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tsiporah Shore | Weill Cornell Medicine | 646-962-7950 | tbs2001@med.cornell.edu |
| Dec 15, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D002330 | Carmustine |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D008558 | Melphalan |
| D003561 | Cytarabine |
| D000074323 | Alemtuzumab |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Follicular Lymphoma |
|
| Hodgkin's Disease |
|
| Mantle Cell Lymphoma |
|
| Transformed Diffuse Large B-Cell Lymphoma |
|
| Peripheral T-Cell Lymphoma |
|
| Other |
|
| 3 Lines |
|
| 4 Lines |
|
| 5+ Lines |
|
| Did Not Proceed to Transplant - Progressive Disease |
|
| Proportion (percent) |
| 81.3 |
| 2-Sided |
| 95 |
| 54.4 |
| 95.9 |
| Other |
Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant |
|
|
|
| OG001 | Chemo Plus Allogeneic 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 Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant |
|
|
|
| OG001 | Chemo Plus Allogeneic 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 Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant |
|
|
|
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 Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant |
|
|
|