Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
Conditions
Keywords
Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Lymphoma, Transplant
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. 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.
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 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.
Interventions
DRUGBendamustine
Days - 24 and Day - 23 followed by a short break of 10 - 14 days.
DRUGCarmustine
300 mg/m2 on Day -6
DRUGEtoposide
100 mg/m2 on days -5 to -2
DRUGMelphalan
140mg/m2 on Day -1
DRUGCytarabine
200 mg/m2 on days -5 to -2
DRUGAlemtuzumab
20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors
BIOLOGICALAutologous Stem Cell Transplantation
BIOLOGICALAllogeneic Stem Cell Transplantation
DRUGRituximab
Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * 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 * 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. * 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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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 |
| 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. |
| 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) |
| 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 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 |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| 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 | 16 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Progressive Disease after Bendamustine | 1 | 3 |
Baseline characteristics
| Characteristic | Total | Chemo Plus Autologous Transplantation | Chemo Plus Allogeneic Transplantation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 4 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 14 Participants | 13 Participants |
| Diagnosis Diffuse Large B-Cell Lymphoma | 7 Participants | 6 Participants | 1 Participants |
| Diagnosis Follicular Lymphoma | 3 Participants | 2 Participants | 1 Participants |
| Diagnosis Hodgkin's Disease | 8 Participants | 5 Participants | 3 Participants |
| Diagnosis Mantle Cell Lymphoma | 3 Participants | 2 Participants | 1 Participants |
| Diagnosis Other | 5 Participants | 1 Participants | 4 Participants |
| Diagnosis Peripheral T-Cell Lymphoma | 2 Participants | 0 Participants | 2 Participants |
| Diagnosis Transformed Diffuse Large B-Cell Lymphoma | 6 Participants | 2 Participants | 4 Participants |
| Lines of Prior Therapy 2 Lines | 14 Lines of Therapy | 11 Lines of Therapy | 3 Lines of Therapy |
| Lines of Prior Therapy 3 Lines | 7 Lines of Therapy | 4 Lines of Therapy | 3 Lines of Therapy |
| Lines of Prior Therapy 4 Lines | 6 Lines of Therapy | 1 Lines of Therapy | 5 Lines of Therapy |
| Lines of Prior Therapy 5+ Lines | 7 Lines of Therapy | 2 Lines of Therapy | 5 Lines of Therapy |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 26 Participants | 14 Participants | 12 Participants |
| Region of Enrollment United States | 34 participants | 18 participants | 16 participants |
| Sex: Female, Male Female | 13 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Male | 21 Participants | 12 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 16 | 7 / 13 |
| other Total, other adverse events | 9 / 34 | 16 / 16 | 13 / 13 |
| serious Total, serious adverse events | 2 / 34 | 4 / 16 | 10 / 13 |
Outcome results
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
Time frame: 14 days after bendamustine treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemo Plus Autologous Transplantation | Number of Patients Able to Proceed to Transplant | Proceeded to Transplant | 16 Participants |
| Chemo Plus Autologous Transplantation | Number of Patients Able to Proceed to Transplant | Did Not Proceed to Transplant - Physician Decision | 1 Participants |
| Chemo Plus Autologous Transplantation | Number of Patients Able to Proceed to Transplant | Did Not Proceed to Transplant - Progressive Disease | 1 Participants |
| Chemo Plus Allogeneic Transplantation | Number of Patients Able to Proceed to Transplant | Proceeded to Transplant | 13 Participants |
| Chemo Plus Allogeneic Transplantation | Number of Patients Able to Proceed to Transplant | Did Not Proceed to Transplant - Physician Decision | 0 Participants |
| Chemo Plus Allogeneic Transplantation | Number of Patients Able to Proceed to Transplant | Did Not Proceed to Transplant - Progressive Disease | 3 Participants |
95% CI: [65.3, 98.6]
95% CI: [54.4, 95.9]
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.
Time frame: 35 Days Post-Transplant
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chemo Plus Autologous Transplantation | Number of Patients Achieving Neutrophil Engraftment | 16 Participants |
| Chemo Plus Allogeneic Transplantation | Number of Patients Achieving Neutrophil Engraftment | 13 Participants |
95% CI: [79.4, 100]
95% CI: [75.3, 100]
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.
Time frame: 74 Days Post-Transplant
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chemo Plus Autologous Transplantation | Number of Patients Achieving Platelet Engraftment | 16 Participants |
| Chemo Plus Allogeneic Transplantation | Number of Patients Achieving Platelet Engraftment | 12 Participants |
95% CI: [79.4, 100]
95% CI: [64, 99.8]
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
Time frame: 30 days after stem cell transplant
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemo Plus Autologous Transplantation | Disease Response 30 Days Post-Transplant | Partial Remission | 2 Participants |
| Chemo Plus Autologous Transplantation | Disease Response 30 Days Post-Transplant | Progressive Disease | 0 Participants |
| Chemo Plus Autologous Transplantation | Disease Response 30 Days Post-Transplant | Stable Disease | 2 Participants |
| Chemo Plus Autologous Transplantation | Disease Response 30 Days Post-Transplant | Not Assessed | 0 Participants |
| Chemo Plus Autologous Transplantation | Disease Response 30 Days Post-Transplant | Complete Remission | 12 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response 30 Days Post-Transplant | Not Assessed | 1 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response 30 Days Post-Transplant | Complete Remission | 7 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response 30 Days Post-Transplant | Partial Remission | 3 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response 30 Days Post-Transplant | Stable Disease | 1 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response 30 Days Post-Transplant | Progressive Disease | 1 Participants |
95% CI: [61.7, 98.4]
95% CI: [46.2, 95]
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
Time frame: 1 year after stem cell transplant
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemo Plus Autologous Transplantation | Disease Response at 1 Year Post-Transplant | Complete Remission | 12 Participants |
| Chemo Plus Autologous Transplantation | Disease Response at 1 Year Post-Transplant | Partial Remission | 1 Participants |
| Chemo Plus Autologous Transplantation | Disease Response at 1 Year Post-Transplant | Stable Disease | 0 Participants |
| Chemo Plus Autologous Transplantation | Disease Response at 1 Year Post-Transplant | Progressive Disease | 3 Participants |
| Chemo Plus Autologous Transplantation | Disease Response at 1 Year Post-Transplant | Not Assessed | 0 Participants |
| Chemo Plus Autologous Transplantation | Disease Response at 1 Year Post-Transplant | Patient Deceased | 0 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response at 1 Year Post-Transplant | Not Assessed | 0 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response at 1 Year Post-Transplant | Complete Remission | 4 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response at 1 Year Post-Transplant | Progressive Disease | 2 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response at 1 Year Post-Transplant | Partial Remission | 0 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response at 1 Year Post-Transplant | Patient Deceased | 7 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response at 1 Year Post-Transplant | Stable Disease | 0 Participants |
95% CI: [54.4, 96]
95% CI: [9.1, 61.4]
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.
Time frame: Within 14 days of salvage chemotherapy treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemo Plus Autologous Transplantation | Disease Response Following Salvage Chemotherapy | Partial Remission | 8 Participants |
| Chemo Plus Autologous Transplantation | Disease Response Following Salvage Chemotherapy | Progressive Disease | 1 Participants |
| Chemo Plus Autologous Transplantation | Disease Response Following Salvage Chemotherapy | Stable Disease | 4 Participants |
| Chemo Plus Autologous Transplantation | Disease Response Following Salvage Chemotherapy | Not Assessed | 1 Participants |
| Chemo Plus Autologous Transplantation | Disease Response Following Salvage Chemotherapy | Complete Remission | 4 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response Following Salvage Chemotherapy | Not Assessed | 1 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response Following Salvage Chemotherapy | Complete Remission | 1 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response Following Salvage Chemotherapy | Partial Remission | 6 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response Following Salvage Chemotherapy | Stable Disease | 2 Participants |
| Chemo Plus Allogeneic Transplantation | Disease Response Following Salvage Chemotherapy | Progressive Disease | 6 Participants |
95% CI: [41, 86.7]
95% CI: [19.8, 70.1]
Secondary
Overall Survival at Day 100 Post-Transplant
The time from stem cell infusion (Day 0) to death from any cause.
Time frame: From Day 0 until time of death, assessed up to 100 days post-transplant
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemo Plus Autologous Transplantation | Overall Survival at Day 100 Post-Transplant | Alive | 16 Participants |
| Chemo Plus Autologous Transplantation | Overall Survival at Day 100 Post-Transplant | Deceased | 0 Participants |
| Chemo Plus Allogeneic Transplantation | Overall Survival at Day 100 Post-Transplant | Alive | 11 Participants |
| Chemo Plus Allogeneic Transplantation | Overall Survival at Day 100 Post-Transplant | Deceased | 2 Participants |
95% CI: [79.4, 100]
95% CI: [54.6, 98.1]
Secondary
Overall Survival at Day 365 Post-Transplant
The time from stem cell infusion (Day 0) to death from any cause.
Time frame: From Day 0 until time of death, assessed up to 365 days post-transplant
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemo Plus Autologous Transplantation | Overall Survival at Day 365 Post-Transplant | Alive | 16 Participants |
| Chemo Plus Autologous Transplantation | Overall Survival at Day 365 Post-Transplant | Deceased | 0 Participants |
| Chemo Plus Allogeneic Transplantation | Overall Survival at Day 365 Post-Transplant | Alive | 6 Participants |
| Chemo Plus Allogeneic Transplantation | Overall Survival at Day 365 Post-Transplant | Deceased | 7 Participants |
95% CI: [79.4, 100]
95% CI: [19.2, 74.9]
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)
Time frame: Stem cell transplant (Day 0) up to 2 years post-transplant
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chemo Plus Autologous Transplantation | Progression-Free Survival After Stem Cell Transplant | NA Months |
| Chemo Plus Allogeneic Transplantation | Progression-Free Survival After Stem Cell Transplant | 8 Months |
95% CI: [5, 25]
Secondary
Transplant-Related Mortality
Death due to any cause other than disease progression within first 100 days post-transplant.
Time frame: From Day 0 until time of death, up to 100 days post-transplant.
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chemo Plus Autologous Transplantation | Transplant-Related Mortality | 0 Participants |
| Chemo Plus Allogeneic Transplantation | Transplant-Related Mortality | 2 Participants |
95% CI: [0, 20.6]
95% CI: [1.9, 45.4]