Trial Outcomes & Findings for Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma (NCT NCT00712582)

NCT ID: NCT00712582

Last Updated: 2022-06-21

Results Overview

2-year PFS from the start of induction therapy conditional on attaining either a negative FDG-PET or a negative biopsy at the interim evaluation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

96 participants

Primary outcome timeframe

2 years

Results posted on

2022-06-21

Participant Flow

Participant milestones

Participant milestones
Measure
Consolidation A
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is \< 80% will receive 3 cycles of standard dose ICE Chemotherapy. Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.
Consolidation B
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075). Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.
Consolidation C
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic\[m3\] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic\[m4\] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service. Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights. Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital.
Overall Study
STARTED
60
32
4
Overall Study
COMPLETED
60
32
4
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Consolidation A
n=60 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is \< 80% will receive 3 cycles of standard dose ICE Chemotherapy. Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.
Consolidation B
n=32 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075). Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.
Consolidation C
n=4 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic\[m3\] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic\[m4\] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service. Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights. Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital.
Total
n=96 Participants
Total of all reporting groups
Age, Continuous
52 years
n=99 Participants
49.5 years
n=107 Participants
59 years
n=206 Participants
51.45 years
n=7 Participants
Sex: Female, Male
Female
29 Participants
n=99 Participants
19 Participants
n=107 Participants
1 Participants
n=206 Participants
49 Participants
n=7 Participants
Sex: Female, Male
Male
31 Participants
n=99 Participants
13 Participants
n=107 Participants
3 Participants
n=206 Participants
47 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
60 Participants
n=99 Participants
32 Participants
n=107 Participants
4 Participants
n=206 Participants
96 Participants
n=7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
White
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Unknown or Not Reported
60 Participants
n=99 Participants
32 Participants
n=107 Participants
4 Participants
n=206 Participants
96 Participants
n=7 Participants
Region of Enrollment
United States
60 Participants
n=99 Participants
32 Participants
n=107 Participants
4 Participants
n=206 Participants
96 Participants
n=7 Participants

PRIMARY outcome

Timeframe: 2 years

2-year PFS from the start of induction therapy conditional on attaining either a negative FDG-PET or a negative biopsy at the interim evaluation.

Outcome measures

Outcome measures
Measure
Consolidation A
n=60 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is \< 80% will receive 3 cycles of standard dose ICE Chemotherapy. Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.
Consolidation B
n=32 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075). Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.
Consolidation C
n=4 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic\[m3\] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic\[m4\] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service. Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights. Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital.
2-year PFS From the Start of Induction Therapy Conditional
86.6 percentage of patients
Interval 78.4 to 95.7
90.6 percentage of patients
Interval 81.1 to 100.0
0.4 percentage of patients
Interval 0.2 to 0.5

SECONDARY outcome

Timeframe: 1 year

Overall survival from the start of induction therapy conditional on attaining either a negative FDG-PET or a negative biopsy at the interim evaluation.

Outcome measures

Outcome measures
Measure
Consolidation A
n=60 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is \< 80% will receive 3 cycles of standard dose ICE Chemotherapy. Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.
Consolidation B
n=32 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075). Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.
Consolidation C
n=4 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic\[m3\] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic\[m4\] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service. Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights. Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital.
Overall Survival at 1 Year
98.3 Percent of patients
Interval 95.1 to 100.0
96.9 Percent of patients
Interval 91.0 to 100.0
50.0 Percent of patients
Interval 18.8 to 100.0

SECONDARY outcome

Timeframe: Through study completion, up to 10 years

Population: N/A - data were not collected

Obtain preliminary data on potential clinical usefulness of the proliferation marker \[18F\] fluorothymidine (FLT) in pts with diffuse large cell lymphoma, using combined (FDG-PET/CT). 18F-FLT uptake by visual analysis (stratified as grades 1-3 vs grades 4-5)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through the completion of study, up to 10 years

Population: N/A - data were not collected

Obtain preliminary data on potential clinical usefulness of the proliferation marker \[18F\] fluorothymidine (FLT) in pts with diffuse large cell lymphoma, using combined (FDG-PET/CT). 18F-FLT uptake by visual analysis (stratified as grades 1-3 vs grades 4-5)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: conclusion of study

Population: N/A - Data were not collected

Outcome measures

Outcome data not reported

Adverse Events

Consolidation A

Serious events: 15 serious events
Other events: 0 other events
Deaths: 5 deaths

Consolidation B

Serious events: 12 serious events
Other events: 0 other events
Deaths: 1 deaths

Consolidation C

Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure
Consolidation A
n=60 participants at risk
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is \< 80% will receive 3 cycles of standard dose ICE Chemotherapy. Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.
Consolidation B
n=32 participants at risk
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075). Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.
Consolidation C
n=4 participants at risk
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow. Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic\[m3\] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic\[m4\] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service. Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights. Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital.
Immune system disorders
Allerg react/hypersens (incl drug fever)
1.7%
1/60 • Up to 2 years
0.00%
0/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Cardiac disorders
Atrial fibrillation
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Blood and lymphatic system disorders
Blood/Bone Marrow, other
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Gastrointestinal disorders
Colitis
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Psychiatric disorders
Confusion
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Gastrointestinal disorders
Constipation
3.3%
2/60 • Up to 2 years
9.4%
3/32 • Up to 2 years
25.0%
1/4 • Up to 2 years
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Investigations
Creatinine
1.7%
1/60 • Up to 2 years
0.00%
0/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Gastrointestinal disorders
Diarrhea
3.3%
2/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/60 • Up to 2 years
0.00%
0/32 • Up to 2 years
25.0%
1/4 • Up to 2 years
Nervous system disorders
Encephalopathy
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Gastrointestinal disorders
Enteritis
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
General disorders
Fatigue
1.7%
1/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Blood and lymphatic system disorders
Febrile neutropenia
10.0%
6/60 • Up to 2 years
25.0%
8/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
General disorders
Fever (in the absence of neutropenia)
3.3%
2/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Metabolism and nutrition disorders
Hyperglycemia
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Blood and lymphatic system disorders
Hemoglobin
5.0%
3/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
25.0%
1/4 • Up to 2 years
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Investigations
Leukocytes
5.0%
3/60 • Up to 2 years
0.00%
0/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Gastrointestinal disorders
Nausea
0.00%
0/60 • Up to 2 years
6.2%
2/32 • Up to 2 years
25.0%
1/4 • Up to 2 years
Investigations
Neutrophils/granulocytes
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Gastrointestinal disorders
Pain - Anus
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Musculoskeletal and connective tissue disorders
Pain - Back
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
General disorders
Pain - Chest/thorax NOS
0.00%
0/60 • Up to 2 years
0.00%
0/32 • Up to 2 years
50.0%
2/4 • Up to 2 years
Musculoskeletal and connective tissue disorders
Pain - Neck
1.7%
1/60 • Up to 2 years
0.00%
0/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Gastrointestinal disorders
Pain - Rectum
1.7%
1/60 • Up to 2 years
0.00%
0/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Vascular disorders
Phlebitis (incl superficial thrombosis)
1.7%
1/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Investigations
Platelets
5.0%
3/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Infections and infestations
Pneumonia (lung)
1.7%
1/60 • Up to 2 years
0.00%
0/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
1.7%
1/60 • Up to 2 years
0.00%
0/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Renal and urinary disorders
Renal/Genitourinary-Other Specify
1.7%
1/60 • Up to 2 years
0.00%
0/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malig-poss related to ca txt
1.7%
1/60 • Up to 2 years
0.00%
0/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Nervous system disorders
Syncope (fainting)
1.7%
1/60 • Up to 2 years
0.00%
0/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Vascular disorders
Thrombosis/thrombus/embolism
1.7%
1/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years
Gastrointestinal disorders
Vomiting
0.00%
0/60 • Up to 2 years
3.1%
1/32 • Up to 2 years
0.00%
0/4 • Up to 2 years

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrew Zelenetz, MD, PhD

Memorial Sloan Kettering Cancer Center

Phone: 646-608-3728

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place