Trial Outcomes & Findings for Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma (NCT NCT00866749)

Last Updated: 2019-09-10

Results Overview

3-year EFS was calculated based on the participants with a complete response (CR). Study regimen considered successful if it exhibits a 3-year EFS rate greater than 60% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

120 participants

Primary outcome timeframe

3 Years

Results posted on

2019-09-10

Participant Flow

Recruitment Period: October 2006 - March 2014

Participant milestones

Participant milestones
Measure	Augmented BFM Therapy Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine Daunorubicin: Starting Dose 25 mg/m\^2 by vein weekly Vincristine: Starting Dose 2 mg by vein weekly PEG-asparaginase: Starting Dose 2000 International units/m2 by vein in week 1 Intrathecal Methotrexate: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid Cyclophosphamide: Starting Dose 1g/m2 by vein in weeks 1 and 5 Cytarabine: 75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months Mercaptopurine: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month Methotrexate: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10 +/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3 Doxorubicin: 25 mg/m2 by vein in weeks 1, 2 and 3 Thioguanine: 60 mg/m2 by mouth daily for two weeks
Overall Study STARTED	120
Overall Study COMPLETED	120
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Augmented BFM Therapy n=120 Participants Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine Daunorubicin: Starting Dose 25 mg/m\^2 by vein weekly Vincristine: Starting Dose 2 mg by vein weekly PEG-asparaginase: Starting Dose 2000 International units/m2 by vein in week 1 Intrathecal Methotrexate: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid Cyclophosphamide: Starting Dose 1g/m2 by vein in weeks 1 and 5 Cytarabine: 75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months Mercaptopurine: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month Methotrexate: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10 +/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3 Doxorubicin: 25 mg/m2 by vein in weeks 1, 2 and 3 Thioguanine: 60 mg/m2 by mouth daily for two weeks
Age, Categorical <=18 years	24 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	96 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	22 years n=93 Participants
Sex: Female, Male Female	44 Participants n=93 Participants
Sex: Female, Male Male	76 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	7 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	7 Participants n=93 Participants
Race (NIH/OMB) White	104 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Region of Enrollment United States	120 participants n=93 Participants

PRIMARY outcome

Timeframe: 3 Years

Population: Of the 108 participants who had a complete response, 68 met the definition for 3 year EFS.

Outcome measures

Outcome measures
Measure	Augmented BFM Therapy n=108 Participants Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine Daunorubicin: Starting Dose 25 mg/m\^2 by vein weekly Vincristine: Starting Dose 2 mg by vein weekly PEG-asparaginase: Starting Dose 2000 International units/m2 by vein in week 1 Intrathecal Methotrexate: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid Cyclophosphamide: Starting Dose 1g/m2 by vein in weeks 1 and 5 Cytarabine: 75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months Mercaptopurine: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month Methotrexate: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10 +/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3 Doxorubicin: 25 mg/m2 by vein in weeks 1, 2 and 3 Thioguanine: 60 mg/m2 by mouth daily for two weeks
3-Year Event-Free Survival (EFS)	68 Participants

PRIMARY outcome

Timeframe: Up to 12 years

Overall Survival defined: Time from date of treatment start until date of death due to any cause or last Follow-up.

Outcome measures

Outcome measures
Measure	Augmented BFM Therapy n=120 Participants Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine Daunorubicin: Starting Dose 25 mg/m\^2 by vein weekly Vincristine: Starting Dose 2 mg by vein weekly PEG-asparaginase: Starting Dose 2000 International units/m2 by vein in week 1 Intrathecal Methotrexate: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid Cyclophosphamide: Starting Dose 1g/m2 by vein in weeks 1 and 5 Cytarabine: 75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months Mercaptopurine: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month Methotrexate: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10 +/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3 Doxorubicin: 25 mg/m2 by vein in weeks 1, 2 and 3 Thioguanine: 60 mg/m2 by mouth daily for two weeks
Overall Survival	121 Months Interval 0.5 to 140.0

PRIMARY outcome

Timeframe: Up to 1 year

Complete Response defined as: Bone Marrow blasts \</= 5%, Platelets \>/= 100 and an Absolute Neutrophil Count (ANC) \>/= 1000

Outcome measures

Outcome measures
Measure	Augmented BFM Therapy n=120 Participants Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine Daunorubicin: Starting Dose 25 mg/m\^2 by vein weekly Vincristine: Starting Dose 2 mg by vein weekly PEG-asparaginase: Starting Dose 2000 International units/m2 by vein in week 1 Intrathecal Methotrexate: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid Cyclophosphamide: Starting Dose 1g/m2 by vein in weeks 1 and 5 Cytarabine: 75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months Mercaptopurine: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month Methotrexate: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10 +/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3 Doxorubicin: 25 mg/m2 by vein in weeks 1, 2 and 3 Thioguanine: 60 mg/m2 by mouth daily for two weeks
Participants With a Complete Response (CR)	108 participants

SECONDARY outcome

Timeframe: up to 3 months

Population: Of the 108 participants who achieved a complete response (CR), 60 participants were MRD negative on day 29 and an additional 27 participants were MRD negative on day 84 for a total 87 MRD negative participants on day 84

To evaluate the prognostic significance of minimal residual disease (MRD) in bone marrow samples of participants who achieved a complete response (CR) at the end of induction (day 29) and at the end of consolidation (day 84) in this group of patients.

Outcome measures

Outcome measures
Measure	Augmented BFM Therapy n=108 Participants Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine Daunorubicin: Starting Dose 25 mg/m\^2 by vein weekly Vincristine: Starting Dose 2 mg by vein weekly PEG-asparaginase: Starting Dose 2000 International units/m2 by vein in week 1 Intrathecal Methotrexate: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid Cyclophosphamide: Starting Dose 1g/m2 by vein in weeks 1 and 5 Cytarabine: 75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months Mercaptopurine: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month Methotrexate: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10 +/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3 Doxorubicin: 25 mg/m2 by vein in weeks 1, 2 and 3 Thioguanine: 60 mg/m2 by mouth daily for two weeks
Participants Achieving Negative Minimal Residual Disease (MRD) Participants with CR and MRD negative on Day 29	60 participants
Participants Achieving Negative Minimal Residual Disease (MRD) Participants with CR and MRD negative on day 84	87 participants

Adverse Events

Augmented BFM Therapy

Serious events: 64 serious events

Other events: 111 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Augmented BFM Therapy n=120 participants at risk Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine Daunorubicin: Starting Dose 25 mg/m\^2 by vein weekly Vincristine: Starting Dose 2 mg by vein weekly PEG-asparaginase: Starting Dose 2000 International units/m2 by vein in week 1 Intrathecal Methotrexate: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid Cyclophosphamide: Starting Dose 1g/m2 by vein in weeks 1 and 5 Cytarabine: 75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months Mercaptopurine: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month Methotrexate: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10 +/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3 Doxorubicin: 25 mg/m2 by vein in weeks 1, 2 and 3 Thioguanine: 60 mg/m2 by mouth daily for two weeks
Gastrointestinal disorders Abdominal Cramps	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Abdominal Pain	5.8% 7/120 • Number of events 15 • Participants were assessed through study completion, for up to 3 years.
Renal and urinary disorders Acute Renal Failure	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Immune system disorders Allergic Reaction	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Blood and lymphatic system disorders Anemia	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Musculoskeletal and connective tissue disorders Ankle Fracture	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Psychiatric disorders Anxiety/depression	1.7% 2/120 • Number of events 2 • Participants were assessed through study completion, for up to 3 years.
Musculoskeletal and connective tissue disorders Avascular Necrosis	2.5% 3/120 • Number of events 3 • Participants were assessed through study completion, for up to 3 years.
General disorders Bone Pain	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Nervous system disorders Central Nervous System, White matter	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Nervous system disorders Cerebrovascular Ischemia	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Nervous system disorders Cognitive Disturbance	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Colitis	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Cardiac disorders Congestive Heart Failure	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Constipation	1.7% 2/120 • Number of events 2 • Participants were assessed through study completion, for up to 3 years.
General disorders Cytomegalovirus antigen positive	1.7% 2/120 • Number of events 3 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Dehydration	5.0% 6/120 • Number of events 6 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Diarrhea	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Eye disorders Double vision	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Duodenal Ulcer	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.3% 4/120 • Number of events 4 • Participants were assessed through study completion, for up to 3 years.
Investigations Elevated Alanine Aminotransferase	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Vascular disorders Embolism	2.5% 3/120 • Number of events 3 • Participants were assessed through study completion, for up to 3 years.
Reproductive system and breast disorders Endometriosis	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
General disorders Fatigue	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
General disorders Fever	9.2% 11/120 • Number of events 16 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Gallbladder Obstruction	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Gastritis	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Gastroparesis	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
General disorders Generalized Edema	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
General disorders Groin Abscess	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
General disorders Headache	5.8% 7/120 • Number of events 10 • Participants were assessed through study completion, for up to 3 years.
General disorders Hemorrhage	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Infections and infestations Herpes Zoster	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Nervous system disorders Hydrocephalus	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Metabolism and nutrition disorders Hyperbilirubinemia	2.5% 3/120 • Number of events 5 • Participants were assessed through study completion, for up to 3 years.
Metabolism and nutrition disorders Hyperglycemia	1.7% 2/120 • Number of events 2 • Participants were assessed through study completion, for up to 3 years.
Metabolism and nutrition disorders Hyponatremia	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Vascular disorders Hypotension	2.5% 3/120 • Number of events 3 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Ileus	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Infections and infestations Infection	18.3% 22/120 • Number of events 29 • Participants were assessed through study completion, for up to 3 years.
General disorders Knee Pain	0.83% 1/120 • Number of events 2 • Participants were assessed through study completion, for up to 3 years.
Blood and lymphatic system disorders Leukocytosis	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Nervous system disorders Leukoencephalopathy	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Mucositis	5.0% 6/120 • Number of events 6 • Participants were assessed through study completion, for up to 3 years.
Musculoskeletal and connective tissue disorders Muscle Weakness	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Nausea/Vomiting	4.2% 5/120 • Number of events 6 • Participants were assessed through study completion, for up to 3 years.
Nervous system disorders Neuropathy	1.7% 2/120 • Number of events 2 • Participants were assessed through study completion, for up to 3 years.
Blood and lymphatic system disorders Neutropenia	1.7% 2/120 • Number of events 2 • Participants were assessed through study completion, for up to 3 years.
Infections and infestations Neutropenic Fever	25.0% 30/120 • Number of events 51 • Participants were assessed through study completion, for up to 3 years.
Musculoskeletal and connective tissue disorders Osteoprosis	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
General disorders Pain	1.7% 2/120 • Number of events 2 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Pancreatitis	5.8% 7/120 • Number of events 9 • Participants were assessed through study completion, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Pleuritic Chest Pain	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Pneumoperitoneum	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Pulmonary Other	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Skin and subcutaneous tissue disorders Rash	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Respiratory Syncytial Virus infection	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Skin and subcutaneous tissue disorders Striae	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Nervous system disorders Stroke	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Nervous system disorders Syncope	1.7% 2/120 • Number of events 2 • Participants were assessed through study completion, for up to 3 years.
Cardiac disorders Tachycardia	1.7% 2/120 • Number of events 2 • Participants were assessed through study completion, for up to 3 years.
Vascular disorders Thrombosis	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.
Reproductive system and breast disorders Vaginal Herpes	0.83% 1/120 • Number of events 1 • Participants were assessed through study completion, for up to 3 years.

Other adverse events

Other adverse events
Measure	Augmented BFM Therapy n=120 participants at risk Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine Daunorubicin: Starting Dose 25 mg/m\^2 by vein weekly Vincristine: Starting Dose 2 mg by vein weekly PEG-asparaginase: Starting Dose 2000 International units/m2 by vein in week 1 Intrathecal Methotrexate: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid Cyclophosphamide: Starting Dose 1g/m2 by vein in weeks 1 and 5 Cytarabine: 75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months Mercaptopurine: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month Methotrexate: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10 +/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3 Doxorubicin: 25 mg/m2 by vein in weeks 1, 2 and 3 Thioguanine: 60 mg/m2 by mouth daily for two weeks
Gastrointestinal disorders Colitis	5.0% 6/120 • Number of events 6 • Participants were assessed through study completion, for up to 3 years.
Skin and subcutaneous tissue disorders Rash	5.0% 6/120 • Number of events 6 • Participants were assessed through study completion, for up to 3 years.
Cardiac disorders Supraventricualr arrhythmia	5.0% 6/120 • Number of events 7 • Participants were assessed through study completion, for up to 3 years.
Metabolism and nutrition disorders Hypoalbuminemia	7.5% 9/120 • Number of events 9 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Dehydration	7.5% 9/120 • Number of events 9 • Participants were assessed through study completion, for up to 3 years.
Metabolism and nutrition disorders Lipase	7.5% 9/120 • Number of events 9 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Mucositis	18.3% 22/120 • Number of events 26 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Constipation	9.2% 11/120 • Number of events 11 • Participants were assessed through study completion, for up to 3 years.
General disorders Pain	24.2% 29/120 • Number of events 38 • Participants were assessed through study completion, for up to 3 years.
Musculoskeletal and connective tissue disorders Osteoporosis	9.2% 11/120 • Number of events 12 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Pancreatitis	9.2% 11/120 • Number of events 12 • Participants were assessed through study completion, for up to 3 years.
Musculoskeletal and connective tissue disorders Osteonecrosis	10.8% 13/120 • Number of events 13 • Participants were assessed through study completion, for up to 3 years.
Infections and infestations Neutropenic Fever	10.0% 12/120 • Number of events 15 • Participants were assessed through study completion, for up to 3 years.
Metabolism and nutrition disorders Hypertriglyceridemia	12.5% 15/120 • Number of events 15 • Participants were assessed through study completion, for up to 3 years.
Nervous system disorders Neuropathy motor	15.8% 19/120 • Number of events 21 • Participants were assessed through study completion, for up to 3 years.
Gastrointestinal disorders Nausea	15.8% 19/120 • Number of events 23 • Participants were assessed through study completion, for up to 3 years.
Metabolism and nutrition disorders Hyperglycemia	18.3% 22/120 • Number of events 24 • Participants were assessed through study completion, for up to 3 years.
Nervous system disorders Neuropathy sensor	19.2% 23/120 • Number of events 24 • Participants were assessed through study completion, for up to 3 years.
Immune system disorders Allergic reaction/hypersensitivity	19.2% 23/120 • Number of events 25 • Participants were assessed through study completion, for up to 3 years.
Vascular disorders Thrombosis	18.3% 22/120 • Number of events 29 • Participants were assessed through study completion, for up to 3 years.
Infections and infestations Infection	58.3% 70/120 • Number of events 138 • Participants were assessed through study completion, for up to 3 years.
Investigations Fibrinogen	35.8% 43/120 • Number of events 44 • Participants were assessed through study completion, for up to 3 years.
Investigations Elevated Alanine Aminotransferase	20.8% 25/120 • Number of events 78 • Participants were assessed through study completion, for up to 3 years.
Metabolism and nutrition disorders Hyperbilirubinemia	47.5% 57/120 • Number of events 87 • Participants were assessed through study completion, for up to 3 years.

Additional Information

Michael Andreeff MD./Professor

The University of Texas MD Anderson Cancer Center

Phone: 713-792-7261

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place