Trial Outcomes & Findings for CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma (NCT NCT01746173)
NCT ID: NCT01746173
Last Updated: 2023-01-30
Results Overview
24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.
Results posted on
2023-01-30
Participant Flow
5 patients were enrolled between July 2013 and January 2014.
Participant milestones
| Measure |
CHOEP + High Dose Therapy + Auto SCT
Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
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|---|---|
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Overall Study
STARTED
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5
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
CHOEP + High Dose Therapy + Auto SCT
Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
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|---|---|
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Overall Study
Disease Progression
|
2
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Baseline Characteristics
CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
CHOEP + High Dose Therapy + Auto SCT
n=5 Participants
Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
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|---|---|
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Age, Continuous
|
55 years
n=99 Participants
|
|
Sex: Female, Male
Female
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2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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5 Participants
n=99 Participants
|
|
Stage
Stage I
|
1 Participants
n=99 Participants
|
|
Stage
Stage II
|
0 Participants
n=99 Participants
|
|
Stage
Stage III
|
2 Participants
n=99 Participants
|
|
Stage
Stage IV
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.Population: The analysis dataset is comprised all enrolled patients.
24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007).
Outcome measures
| Measure |
CHOEP + High Dose Therapy + Auto SCT
n=5 Participants
Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
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|---|---|
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24-month Progression-Free Survival Rate
|
0.0 proportion of patients
Interval 0.0 to 0.45
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SECONDARY outcome
Timeframe: Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy. Response was assessed was using a combination of CT scans and PET scans. Partial and complete response were categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks.
Outcome measures
| Measure |
CHOEP + High Dose Therapy + Auto SCT
n=5 Participants
Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
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|---|---|
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Induction Response
|
.60 proportion of patients
Interval 0.19 to 0.92
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Adverse Events
CHOEP + High Dose Therapy + Auto SCT
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CHOEP + High Dose Therapy + Auto SCT
n=5 participants at risk
Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
40.0%
2/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
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|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophil count decreased
|
40.0%
2/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
White blood cell decreased
|
40.0%
2/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
Other adverse events
| Measure |
CHOEP + High Dose Therapy + Auto SCT
n=5 participants at risk
Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
|
|---|---|
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Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
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|
Gastrointestinal disorders
Anal stenosis
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Chills
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema limbs
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fatigue
|
60.0%
3/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fever
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infections and infestations - Other
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
White blood cell decreased
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
20.0%
1/5 • Toxicity was assessed weekly during 6 cycles of induction (up to 18 weeks), within 0-3 days prior to day 1 of stem cell mobilization, day +30 post-ASCT. Median duration of induction therapy was 6 cycles/18 weeks (range 2-6 cycles). 3 patients continued to ASCT within 7 months of study enrollment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. No further data is available to specify classification of other beyond the general term.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place