Trial Outcomes & Findings for S0530 Cytarabine and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (NCT NCT00337168)
NCT ID: NCT00337168
Last Updated: 2015-03-25
Results Overview
Complete remission is defined as: less than 5% bone marrow blasts, neutrophils greater or equal to 1,000 per microliter, platelets greater than 100,000 per microliter, no blasts in the peripheral blood, and no extramedullary disease
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Between day 28 and day 35 inclusive
Results posted on
2015-03-25
Participant Flow
Participant milestones
| Measure |
Induction
Clofarabine (40 mg per meters squared per day) and cytarabine (1 g per meters squared per day)
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
Eligible
|
37
|
|
Overall Study
Eligible and Treated
|
36
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Induction
Clofarabine (40 mg per meters squared per day) and cytarabine (1 g per meters squared per day)
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Not protocol specified
|
2
|
|
Overall Study
Did not start therapy
|
1
|
Baseline Characteristics
S0530 Cytarabine and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Induction
n=36 Participants
|
|---|---|
|
Age, Continuous
|
41 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between day 28 and day 35 inclusivePopulation: Eligible patients who started therapy
Complete remission is defined as: less than 5% bone marrow blasts, neutrophils greater or equal to 1,000 per microliter, platelets greater than 100,000 per microliter, no blasts in the peripheral blood, and no extramedullary disease
Outcome measures
| Measure |
Induction
n=36 Participants
|
|---|---|
|
Number of Patients With Complete Remission
|
3 participants
|
SECONDARY outcome
Timeframe: On average, two weeks before treatment startedPopulation: Eligible patients who submitted paraffin-embedded tissue
Expression was examined in paraffin-embedded tissue by immunohistochemistry. Intensities were scored on a 0-2+ scale. High expression was a score of 2+.
Outcome measures
| Measure |
Induction
n=13 Participants
|
|---|---|
|
Expression of Nucleoside Transporters
High expression of dCK nuclear
|
4 participants
|
|
Expression of Nucleoside Transporters
High expression of hENT1
|
7 participants
|
|
Expression of Nucleoside Transporters
High expression of hCNT3
|
6 participants
|
|
Expression of Nucleoside Transporters
High expression of dCK cytoplasmic
|
4 participants
|
SECONDARY outcome
Timeframe: On average, 2 weeks before treatment startedPopulation: Eligible patients with acceptable centrally reviewed cytogenetics
Outcome measures
| Measure |
Induction
n=17 Participants
|
|---|---|
|
Number of Patients With Very Poor Risk Cytogenetics
|
10 participants
|
SECONDARY outcome
Timeframe: Patients were assess for adverse events after each induction cycle (up to two cycles) and after the one consolidation cyclePopulation: 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
| Measure |
Induction
n=36 Participants
|
|---|---|
|
Toxicity
ALT, SGPT (serum glutamic pyruvic transaminase)
|
5 Participants with a given type of AE
|
|
Toxicity
Ascites (non-malignant)
|
2 Participants with a given type of AE
|
|
Toxicity
Bilirubin (hyperbilirubinemia)
|
3 Participants with a given type of AE
|
|
Toxicity
Pain - Bone
|
1 Participants with a given type of AE
|
|
Toxicity
Platelets
|
20 Participants with a given type of AE
|
|
Toxicity
Pleural effusion (non-malignant)
|
1 Participants with a given type of AE
|
|
Toxicity
Renal failure
|
3 Participants with a given type of AE
|
|
Toxicity
Tumor lysis syndrome
|
1 Participants with a given type of AE
|
|
Toxicity
AST, SGOT (serum glut oxaloacetic transaminase)
|
7 Participants with a given type of AE
|
|
Toxicity
Albumin, serum-low (hypoalbuminemia)
|
3 Participants with a given type of AE
|
|
Toxicity
Anorexia
|
1 Participants with a given type of AE
|
|
Toxicity
Calcium, serum-low (hypocalcemia)
|
1 Participants with a given type of AE
|
|
Toxicity
Colitis
|
1 Participants with a given type of AE
|
|
Toxicity
Colitis, infectious (e.g., Clostridium difficile)
|
2 Participants with a given type of AE
|
|
Toxicity
Confusion
|
1 Participants with a given type of AE
|
|
Toxicity
Creatinine
|
4 Participants with a given type of AE
|
|
Toxicity
DIC (disseminated intravascular coagulation)
|
1 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
Dermatology/Skin-Other (Specify)
|
1 Participants with a given type of AE
|
|
Toxicity
Diarrhea
|
2 Participants with a given type of AE
|
|
Toxicity
Dyspnea (shortness of breath)
|
1 Participants with a given type of AE
|
|
Toxicity
Edema: limb
|
1 Participants with a given type of AE
|
|
Toxicity
Fatigue (asthenia, lethargy, malaise)
|
2 Participants with a given type of AE
|
|
Toxicity
Febrile neutropenia
|
14 Participants with a given type of AE
|
|
Toxicity
Glucose, serum-high (hyperglycemia)
|
1 Participants with a given type of AE
|
|
Toxicity
Hemoglobin
|
13 Participants with a given type of AE
|
|
Toxicity
Hypotension
|
3 Participants with a given type of AE
|
|
Toxicity
Hypoxia
|
1 Participants with a given type of AE
|
|
Toxicity
INR
|
1 Participants with a given type of AE
|
|
Toxicity
Infec with Gr 3\4 neutrophils - Bladder (urin
|
1 Participants with a given type of AE
|
|
Toxicity
IInfec with Gr 3\4 neutrophils - Blood
|
9 Participants with a given type of AE
|
|
Toxicity
Infec with Gr 3\4 neutrophils - Catheter-rela
|
1 Participants with a given type of AE
|
|
Toxicity
Infec with Gr 3\4 neutrophils - Colon
|
2 Participants with a given type of AE
|
|
Toxicity
Infec with Gr 3\4 neutrophils - Conjunctiva
|
1 Participants with a given type of AE
|
|
Toxicity
Infec with Gr 3\4 neutrophils - Larynx
|
1 Participants with a given type of AE
|
|
Toxicity
Infec with Gr 3\4 neutrophils - Lung (pneumon
|
2 Participants with a given type of AE
|
|
Toxicity
Infec with Gr 3\4 neutrophils - Skin (celluli
|
1 Participants with a given type of AE
|
|
Toxicity
Infec with Gr 3\4 neutrophils - Urinary tract
|
1 Participants with a given type of AE
|
|
Toxicity
Infec with Gr 3\4 neutrophils - Wound
|
1 Participants with a given type of AE
|
|
Toxicity
Infection with unknown ANC - Lung (pneumonia)
|
1 Participants with a given type of AE
|
|
Toxicity
Infection-Other (Specify)
|
1 Participants with a given type of AE
|
|
Toxicity
Leukocytes (total WBC)
|
11 Participants with a given type of AE
|
|
Toxicity
Liver dysfunction/failure (clinical)
|
1 Participants with a given type of AE
|
|
Toxicity
Lymphopenia
|
7 Participants with a given type of AE
|
|
Toxicity
Mental status
|
1 Participants with a given type of AE
|
|
Toxicity
Neutrophils/granulocytes (ANC/AGC)
|
18 Participants with a given type of AE
|
|
Toxicity
PTT (Partial thromboplastin time)
|
1 Participants with a given type of AE
|
|
Toxicity
Pain - Abdomen NOS
|
1 Participants with a given type of AE
|
|
Toxicity
Pain - Back
|
1 Participants with a given type of AE
|
|
Toxicity
Pneumonitis/pulmonary infiltrates
|
1 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)
|
4 Participants with a given type of AE
|
|
Toxicity
Pruritus/itching
|
1 Participants with a given type of AE
|
|
Toxicity
Restrictive cardiomyopathy
|
1 Participants with a given type of AE
|
|
Toxicity
Sodium, serum-high (hypernatremia)
|
1 Participants with a given type of AE
|
|
Toxicity
Sodium, serum-low (hyponatremia)
|
2 Participants with a given type of AE
|
|
Toxicity
Supraventricular and nodal arrhythmia
|
1 Participants with a given type of AE
|
|
Toxicity
Typhlitis (cecal inflammation)
|
1 Participants with a given type of AE
|
|
Toxicity
Uric acid, serum-high (hyperuricemia)
|
1 Participants with a given type of AE
|
Adverse Events
Induction
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction
n=36 participants at risk
Up to two induction cycles with clofarabine and cytarabine
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.8%
1/36 • 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
|
|
Gastrointestinal disorders
Colitis
|
2.8%
1/36 • 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
|
2.8%
1/36 • 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
|
2.8%
1/36 • 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
|
|
Renal and urinary disorders
Renal failure
|
2.8%
1/36 • 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
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • 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
| Measure |
Induction
n=36 participants at risk
Up to two induction cycles with clofarabine and cytarabine
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
38.9%
14/36 • 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
|
|
Blood and lymphatic system disorders
Hemoglobin
|
50.0%
18/36 • 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
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Sinus tachycardia
|
8.3%
3/36 • 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
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
5.6%
2/36 • 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
|
|
Gastrointestinal disorders
Constipation
|
8.3%
3/36 • 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
|
|
Gastrointestinal disorders
Diarrhea
|
30.6%
11/36 • 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
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
5.6%
2/36 • 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
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
5.6%
2/36 • 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
|
|
Gastrointestinal disorders
Nausea
|
47.2%
17/36 • 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
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
16.7%
6/36 • 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
|
|
Gastrointestinal disorders
Typhlitis (cecal inflammation)
|
5.6%
2/36 • 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
|
|
Gastrointestinal disorders
Vomiting
|
13.9%
5/36 • 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
Edema: limb
|
16.7%
6/36 • 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
Fatigue (asthenia, lethargy, malaise)
|
27.8%
10/36 • 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
Rigors/chills
|
8.3%
3/36 • 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
Colitis, infectious (e.g., Clostridium difficile)
|
5.6%
2/36 • 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
|
25.0%
9/36 • 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 - Colon
|
5.6%
2/36 • 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
|
8.3%
3/36 • 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
ALT, SGPT (serum glutamic pyruvic transaminase)
|
30.6%
11/36 • 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
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
30.6%
11/36 • 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
Alkaline phosphatase
|
13.9%
5/36 • 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
Bilirubin (hyperbilirubinemia)
|
27.8%
10/36 • 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
Creatinine
|
19.4%
7/36 • 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
INR (International Normalized Ratio of prothrombin time)
|
5.6%
2/36 • 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)
|
30.6%
11/36 • 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
Lymphopenia
|
19.4%
7/36 • 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
Metabolic/Laboratory-Other (Specify)
|
5.6%
2/36 • 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
Neutrophils/granulocytes (ANC/AGC)
|
50.0%
18/36 • 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
PTT (Partial thromboplastin time)
|
8.3%
3/36 • 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
|
55.6%
20/36 • 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
Weight loss
|
5.6%
2/36 • 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
Albumin, serum-low (hypoalbuminemia)
|
25.0%
9/36 • 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
Anorexia
|
13.9%
5/36 • 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
Calcium, serum-low (hypocalcemia)
|
19.4%
7/36 • 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
Glucose, serum-high (hyperglycemia)
|
11.1%
4/36 • 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
Magnesium, serum-low (hypomagnesemia)
|
5.6%
2/36 • 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
Potassium, serum-high (hyperkalemia)
|
8.3%
3/36 • 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
Potassium, serum-low (hypokalemia)
|
25.0%
9/36 • 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
Sodium, serum-low (hyponatremia)
|
13.9%
5/36 • 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
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
8.3%
3/36 • 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
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
8.3%
3/36 • 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
|
|
Nervous system disorders
Pain - Head/headache
|
27.8%
10/36 • 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
|
|
Psychiatric disorders
Confusion
|
11.1%
4/36 • 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
|
|
Psychiatric disorders
Insomnia
|
11.1%
4/36 • 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
|
|
Psychiatric disorders
Mood alteration - depression
|
5.6%
2/36 • 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
|
|
Renal and urinary disorders
Renal failure
|
5.6%
2/36 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
3/36 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
8.3%
3/36 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
5.6%
2/36 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
5.6%
2/36 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
5.6%
2/36 • 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
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify)
|
11.1%
4/36 • 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
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
5.6%
2/36 • 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
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
16.7%
6/36 • 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
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
8.3%
3/36 • 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
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
8.3%
3/36 • 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
|
|
Vascular disorders
Hypotension
|
8.3%
3/36 • 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
|
Additional Information
SWOG Leukemia Statistician
SWOG Statistical Office
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place