Trial Outcomes & Findings for S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (NCT NCT00109837)

Last Updated: 2015-03-25

Results Overview

A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

79 participants

Primary outcome timeframe

After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year

Results posted on

2015-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Treatment included: Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth
Overall Study STARTED	79
Overall Study Eligible	78
Overall Study Eligible and Ph-	61
Overall Study Eligible and Ph- and Treated	60
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Treatment included: Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth
Overall Study Adverse Event	2
Overall Study Refusal unrelated to adverse effects	1
Overall Study Death	1
Overall Study BCR/ABL+ or Ph+	17
Overall Study Not treated	1
Overall Study Ineligible	1

Baseline Characteristics

S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=60 Participants Treatment included: Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth
Age, Continuous	42 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year

Population: Eligible, Ph-, treated, and evaluable patients

A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study.

Outcome measures

Outcome measures
Measure	Treatment n=58 Participants Treatment included: Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth
Continuous Complete Remission at 1 Year	21 participants

SECONDARY outcome

Timeframe: Patients were assessed for adverse events after the induction cycle

Population: Eligible patients who started therapy

Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

Outcome measures

Outcome measures
Measure	Treatment n=74 Participants Treatment included: Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth
Toxicity Albumin, serum-low (hypoalbuminemia)	3 Participants with a given type of AE
Toxicity Alkaline phosphatase	2 Participants with a given type of AE
Toxicity Anorexia	2 Participants with a given type of AE
Toxicity Ascites (non-malignant)	1 Participants with a given type of AE
Toxicity Hypertension	2 Participants with a given type of AE
Toxicity Hypotension	3 Participants with a given type of AE
Toxicity Hypoxia	2 Participants with a given type of AE
Toxicity Ileus, GI (functional obstruction of bowel)	1 Participants with a given type of AE
Toxicity Sodium, serum-low (hyponatremia)	6 Participants with a given type of AE
Toxicity Uric acid, serum-high (hyperuricemia)	1 Participants with a given type of AE
Toxicity Vomiting	1 Participants with a given type of AE
Toxicity ALT, SGPT (serum glutamic pyruvic transaminase)	17 Participants with a given type of AE
Toxicity AST, SGOT (serum glut oxaloacetic transaminase)	13 Participants with a given type of AE
Toxicity Bilirubin (hyperbilirubinemia)	6 Participants with a given type of AE
Toxicity Calcium, serum-low (hypocalcemia)	7 Participants with a given type of AE
Toxicity Cholecystitis	1 Participants with a given type of AE
Toxicity Cholesterol, serum-high (hypercholesterolemia)	2 Participants with a given type of AE
Toxicity Coagulation-Other (Specify)	1 Participants with a given type of AE
Toxicity Colitis, infectious (e.g., Clostridium difficile)	1 Participants with a given type of AE
Toxicity Constipation	1 Participants with a given type of AE
Toxicity DIC (disseminated intravascular coagulation)	2 Participants with a given type of AE
Toxicity Death not assoc with CTCAE term-Multi-organ fail	1 Participants with a given type of AE
Toxicity Edema: limb	1 Participants with a given type of AE
Toxicity Fatigue (asthenia, lethargy, malaise)	3 Participants with a given type of AE
Toxicity Febrile neutropenia	18 Participants with a given type of AE
Toxicity Fever (in the abs of neutropenia)	1 Participants with a given type of AE
Toxicity Fibrinogen	11 Participants with a given type of AE
Toxicity Glucose, serum-high (hyperglycemia)	16 Participants with a given type of AE
Toxicity Glucose, serum-low (hypoglycemia)	1 Participants with a given type of AE
Toxicity Hemoglobin	33 Participants with a given type of AE
Toxicity Infec(doc clin or mibio) w/ Gr 3/4 neut-Anal	1 Participants with a given type of AE
Toxicity Infec(doc clin or mibio) w/ Gr 3/4 neut-Bladder	1 Participants with a given type of AE
Toxicity Infec(doc clin or mibio) w/ Gr 3/4 neut-Blood	11 Participants with a given type of AE
Toxicity Infec(doc clin or mibio) w/ Gr 3/4 neut-Bronchus	1 Participants with a given type of AE
Toxicity IInfec(doc clin or mibio) w/ Gr 3/4 neut-Catheter	1 Participants with a given type of AE
Toxicity Infec(doc clin or mibio) w/ Gr 3/4 neut-Eye NOS	1 Participants with a given type of AE
Toxicity Infec(doc clin or mibio) w/ Gr 3/4 neut-Lung	1 Participants with a given type of AE
Toxicity Infec(doc clin or mibio) w/ Gr 3/4 neut-Nose	1 Participants with a given type of AE
Toxicity Infec(doc clin or mibio) w/ Gr 3/4 neut-Pharynx	1 Participants with a given type of AE
Toxicity Infec(doc clin or mibio) w/ Gr 3/4 neut-Ur tract	2 Participants with a given type of AE
Toxicity Infec with nor ANC or Gr 1/2 neut-Lung (pneumonia)	2 Participants with a given type of AE
Toxicity Infection-Other (Specify)	1 Participants with a given type of AE
Toxicity Leukocytes (total WBC)	43 Participants with a given type of AE
Toxicity Lipase	1 Participants with a given type of AE
Toxicity Liver dysfunction/failure (clinical)	2 Participants with a given type of AE
Toxicity Lymphopenia	19 Participants with a given type of AE
Toxicity Magnesium, serum-high (hypermagnesemia)	1 Participants with a given type of AE
Toxicity Mucositis/stomatitis (clinical exam) - Oral cavity	2 Participants with a given type of AE
Toxicity Mucositis/stomatitis (funct/symp) - Oral cavity	1 Participants with a given type of AE
Toxicity Mucositis/stomatitis (func/symp) - Pharynx	1 Participants with a given type of AE
Toxicity Muscle weak,gen spec area-Whole body	2 Participants with a given type of AE
Toxicity Nausea	3 Participants with a given type of AE
Toxicity Neuropathy: motor	1 Participants with a given type of AE
Toxicity Neutrophils/granulocytes (ANC/AGC)	47 Participants with a given type of AE
Toxicity Pain - Abdomen NOS	1 Participants with a given type of AE
Toxicity Pain - Bone	1 Participants with a given type of AE
Toxicity Pain - Neck	1 Participants with a given type of AE
Toxicity Pancreatic endocrine: glucose intolerance	1 Participants with a given type of AE
Toxicity Pancreatitis	1 Participants with a given type of AE
Toxicity Phosphate, serum-low (hypophosphatemia)	1 Participants with a given type of AE
Toxicity Platelets	44 Participants with a given type of AE
Toxicity Potassium, serum-high (hyperkalemia)	1 Participants with a given type of AE
Toxicity Potassium, serum-low (hypokalemia)	7 Participants with a given type of AE
Toxicity Rash/desquamation	1 Participants with a given type of AE
Toxicity Renal failure	2 Participants with a given type of AE
Toxicity Thrombosis/thrombus/embolism	1 Participants with a given type of AE
Toxicity Thrombotic microangiopathy	2 Participants with a given type of AE
Toxicity Triglyceride, serum-high (hypertriglyceridemia)	1 Participants with a given type of AE
Toxicity Tumor lysis syndrome	5 Participants with a given type of AE
Toxicity Typhlitis (cecal inflammation)	1 Participants with a given type of AE

Adverse Events

First Induction

Serious events: 2 serious events

Other events: 71 other events

Deaths: 0 deaths

Second Induction

Serious events: 2 serious events

Other events: 54 other events

Deaths: 0 deaths

Consolidation

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Maintenance

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	First Induction n=75 participants at risk One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase.	Second Induction n=56 participants at risk A second induction cycle with allopurinol , dexamergasone, G-CSF, high-dose ara-C and mitoxantrone	Consolidation n=33 participants at risk Patients who had a CR after induction could receive one course of consolidation therapy consisting of cyclophosphamide, ara-C, 6-mercaptopurine, G-CSF and methotrexate	Maintenance n=12 participants at risk Patient with a CR after consolidation could receive up to four courses of maintenance. Course 1 included 6-mercaptopurine and methotrexate. course 2 included vincristine, adriamycin, and dexamethasone. course 3 included cyclophosphamide, 6-thioguanine, and ara-C. course 4 included 6-mercaptopurine and methotrexate
Gastrointestinal disorders Pancreatitis	1.3% 1/75 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/56 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/33 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
General disorders Death not associated with CTCAE term - Multi-organ failure	1.3% 1/75 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/56 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/33 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Infections and infestations Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood	0.00% 0/75 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	1.8% 1/56 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/33 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Infections and infestations Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon	0.00% 0/75 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	1.8% 1/56 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/33 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Injury, poisoning and procedural complications Hemorrhage/bleeding associated with surgery, intra-operative or post-operative	0.00% 0/75 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	1.8% 1/56 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/33 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Investigations Leukocytes (total WBC)	0.00% 0/75 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/56 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	3.0% 1/33 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Investigations Platelets	0.00% 0/75 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/56 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	3.0% 1/33 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Metabolism and nutrition disorders Triglyceride, serum-high (hypertriglyceridemia)	1.3% 1/75 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/56 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/33 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment	0.00% 0/12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment

Other adverse events

Additional Information

SWOG Leukemia Statistician

SWOG Statistical Office

Phone: 206-667-4408

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place