Phase I Pharmacokinetic Study of Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction
Background:
- Belinostat is a histone deacetylase (HDAC) inhibitor. HDACs are frequently deregulated
in cancer cells, leading to an increase in deacetylation and the silencing of genes that
normally control cell cycle arrest and apoptosis.
- Belinostat has growth inhibitory activity in several malignancies in vitro and in vivo,
both as a single agent and in combination with chemotherapeutic agents. Several Phase I
and II clinical trials have been conducted to date in patients with solid tumor and
hematologic malignancies; belinostat has been generally well tolerated.
- Belinostat is metabolized in the liver and therefore, the safety and dosing of
belinostat needs to be established in patients with varying degrees of hepatic
dysfunction.
Objectives:
- Establish the safety and tolerability of belinostat given on days 1 through 5 of 21-day
cycles to patients with varying degrees of liver dysfunction.
- Define the maximum tolerated dose (MTD) and recommended dose of belinostat given on days
1 through 5 of 21-day cycles to patients with varying degrees of liver dysfunction.
- Evaluate the pharmacokinetics (PK) of one dose of belinostat (400 mg/m(2)) in patients
with varying degrees of liver dysfunction.
- Obtain preliminary evidence of anti-tumor activity at tolerable doses of belinostat in
patients with varying degrees of liver dysfunction.
- Measure direct versus indirect bilirubin levels and correlate these with observed
toxicities, PK.
Eligibility:
-Adults with solid tumors or lymphomas whose disease has progressed after standard therapy or
who have no acceptable standard treatment options. Patients with normal and varying degrees
of hepatic dysfunction (mild, moderate, and severe) are eligible.
Study Design:
-Patients will be divided into 4 dose escalation cohorts based on their level of liver
dysfunction. Belinostat will be administered intravenously (IV) over 30 minutes. On day -7
(Cycle 1 only), all patients will receive a single dose of 400 mg/m(2) belinostat. On days 1
through 5 of each cycle, patients will receive belinostat at a dose dependent on the level of
hepatic dysfunction and dose level. Mild, moderate, and severe liver dysfunction cohorts will
begin on dose level 1; patients with normal hepatic function will not have their dose
escalated (see below). The total length of Cycle 1 will be 28 days; all other cycles will be
21 days. No more than 12 evaluable patients with normal hepatic function will be accrued.
HLA-mismatched Allogeneic Cellular Therapy (HMMACT) After Chemotherapy in High Risk Acute Myeloid Leukemia
PRIMARY OBJECTIVES:
I. To assess the feasibility of cytarabine based chemotherapy and human leukocyte antigen
(HLA)-mismatched allogeneic cellular therapy (HMMACT) in patients with high risk acute
myeloid leukemia (AML), with feasibility measured by induction mortality (IM) and complete
response rate.
SECONDARY OBJECTIVES:
I. To obtain preliminary estimates of clinical outcome following cytarabine based
chemotherapy and HMMACT in patients with high risk AML, as measured by event free survival
(EFS) and overall survival (OS).
II. To further evaluate the safety outcomes of induction and consolidation of cytarabine and
HMMACT in terms of serious infections (grade 4), time to recovery of absolute neutrophil
counts and platelets and incidence of graft versus host disease (GvHD).
III. To further evaluate the feasibility of this approach in terms of identifying a suitable
donor in this elderly population.
IV. To compare in preliminary manner the clinical outcomes of cytarabine and HMMACT in
patients with high risk AML as measured by complete response rate (CRR), event free survival
(EFS) and overall survival (OS) by donor/recipient HLA-C1 vs C2 pairs.
V. To characterize in a preliminary manner, the numbers of suppressor regulatory T cells
(Tregs), T helper 17 cells (Th17), and cytotoxic T cells during pre and post HMMACT
treatment, and with clinical outcomes in leukemia.
OUTLINE:
INDUCTION CHEMOTHERAPY: Patients receive mitoxantrone hydrochloride intravenously (IV) on
days 1-3 and cytarabine IV on days 1-7.
HMMACT: Patients receive filgrastim (G-CSF) mobilized peripheral blood stem cells (G-PBSC) on
day 9. After completion of study treatment, patients are followed up monthly for 3 years.
S1013: A Prospective Study of Epidermal Growth Factor Receptor (HER-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer Therapy-EGFRI 18(FACT-EGFRI 18) Questionnaire for EGFRI-Induced Skin Toxicities
OBJECTIVES:
Primary
- To establish psychometric properties for the Functional Assessment of Cancer Therapy
Epidermal Growth Factor Receptor Inhibitor (FACT-EGFRI 18) module (based on criterion
validity, known group's validity, internal consistency reliability, and responsiveness
to change) as a patient-reported outcome (PRO) measure of EGFRI-induced skin-related
toxicity.
Secondary
- To document minimally important differences over time for the FACT-EGFRI 18 by comparing
mean changes in this PRO measure to the patient's direct assessment of change using two
anchor items (change in skin condition severity and impact).
- To examine the association between toxicity profiles (severity and time to onset), and
treatment profiles (e.g., delays and discontinuation) and the FACT-EGFRI 18 scores.
- To assess degree of concordance between FACT-EGFRI 18 ratings and study site physician
CTCAE Version 4.0 EGFRI-Induced Dermatologic Toxicity Grading Assessment ratings.
- To evaluate feasibility outcomes.
OUTLINE: This is a multicenter study.
Patients complete the S1013 Functional Assessment of Cancer Therapy Epidermal Growth Factor
Receptor Inhibitor (FACT-EGFRI 18) at baseline and prior to beginning therapy and clinical
assessment. Patients also complete FACT-EGFRI 18 and the Changes in Skin Symptoms on days 1*,
8**, 15, 22, 29, 36, 43, 71, 99, and 127. Patients who do not develop any grade of
papulopustular rash within 42 days are removed from study.
Investigators performing the patients' clinical assessment complete the EGFRI-Induced
Dermatologic Toxicity Grading Assessment on days 1, 8, 15, 22, 29, 36, 43, 71, 99, and 127,
and the Treatment Form assessment on days 22, 43, 71, 99, and 127. Nurses or clinical trial
administrators (CRA) also complete the S1013 Cover Sheet for Patient Complete Questionnaires
accompanying the FACT-EGFRI 18 patients' questionnaires at each schedule assessment.
NOTE: *Patients start EGFRI therapy.
NOTE: **Change in Skin Symptoms questionnaire starts on Day 8.
Phase Ib Multicenter, Cohort Dose Escalation Trial to Determine the Safety, Tolerance and Preliminary Antineoplastic Activity of Gemcitabine Administered in Combination With Continuous Intravenous Doses of PRI-724, a CBP/ β- Catenin Inhibitor, to Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Eligible for Second-Line Therapy After Failing First-Line Therapy With FOLFIRINOX (or FOLFOX)
PRI-724 is a small molecule antagonist that binds to the co-activator CBP thereby
specifically inhibiting the subset of Wnt/β-catenin-driven genes that are up-regulated in
cancer cells. PRI-724 is being developed as a potential antineoplastic agent.
Purpose:
To determine the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated
dose (MTD) of sequential escalating doses per cohort of PRI-724 administered in combination
with gemcitabine to patients with adenocarcinoma of the pancreas that is locally advanced,
metastatic, or otherwise inoperable, who are candidates for second-line therapy after failing
first-line therapy with FOLFIRINOX (i.e., folinic acid [leucovorin], fluorouracil,
irinotecan, oxaliplatin)
- PRI-724: 320, 640, 905 mg/m2/day, continuous intravenous (CIV) infusion over 24 h, daily
× 7 days, 1 week on with 1 week recovery × 2 (4 weeks equals 1 cycle)
- Gemcitabine: 1000 mg/m2 IV over 30 minutes; 3 weeks on with 1 week recovery (4 weeks
equals 1 cycle)
Patients with documented, measurable or evaluable adenocarcinoma of the pancreas that is
locally advanced, metastatic, or otherwise inoperable, who are candidates for second-line
therapy after failing first-line therapy with FOLFIRINOX, will be entered into this phase 1b,
multicenter, open-label, non-randomized, dose-escalation per cohort study. The trial is
designed to evaluate the safety, tolerability, DLT(s), and MTD of escalating doses of
PRI-724, a CBP/ β- catenin inhibitor, when administered in combination with a standard dose
of gemcitabine. Correlative studies include characterization of the PK profiles of PRI-724
and gemcitabine, evaluation of the utility of potential PD markers of PRI-724 activity, as
well as preliminary assessment of the antineoplastic activity of PRI-724 plus gemcitabine in
this patient population.
A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional, Cross-over, Phase II.5 Study of Saracatinib (AZD0530), a Selective Src Kinase Inhibitor, In Patients With Recurrent Osteosarcoma Localized to the Lung
Further details provided by SARC (Sarcoma Alliance for Research through Collaboration):
After complete surgical removal of their cancer, patients will be randomly assigned to
receive either Saracatinib or placebo (a sugar pill) throughout the study. Patients will take
Saracatinib (or placebo) once daily by mouth for a total of 364 days. The duration of
treatment is divided into 13 cycles, 28 days each cycle with no breaks in between.
Patients will be seen for interim medical history, physical exam and laboratory studies prior
to each cycle. To monitor for recurrence of tumor, patients will undergo thoracic CT scans at
3-4 weeks, 6-8 weeks, at 3 months, at 6 months, at 9 months, at 12 months, then every 6
months up to 2 years, and then every year up to 5 years after starting treatment. An
electrocardiogram (ECG) will be taken at 3 months, and a bone scan will be performed at 12
months.
Patients who recur in the lung while on-study and who are thought to be amenable to complete
surgical resection will be able to find out if they were receiving placebo or saracatinib.
Those patients who were receiving placebo may then have the option of undergoing surgical
resection. If fully resected of all recurrent disease,they will be given the option of
receiving oral therapy with saracatinib. Saracatinib will be administered as a once daily,
oral dose of 175 mg, for a 28-day cycle, with no breaks between cycles. The duration of
treatment with saracatinib will be thirteen 28-day cycles (364 days total). If complete
resection of all lung nodules is not achieved, the patient will be removed from the study.
Patients who recur in locations other than the lung while on-study will be taken off study at
that time.
Blood and tumor samples for research purposes will be collected at the time the tumor is
removed.
After completing all 13 cycles, patients will be followed for approximately every 3 months
until 2 years from starting treatment, then approximately every 6 months until 4 years from
starting treatment, and once at year 5.
Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
PRIMARY OBJECTIVES:
I. To evaluate the activity of eribulin (eribulin mesylate) in the management of advanced or
recurrent cervical cancer (progression-free survival [PFS].
SECONDARY OBJECTIVES:
I. To describe the toxicity profile of eribulin in patients with advanced or recurrent
cervical cancer.
II. To estimate the survival of patients with advanced or recurrent cervical cancer treated
with eribulin.
III. To evaluate potential correlative studies as predictive or prognostic makers in this
patient population (glucose-regulated protein 78 [GRP78] levels in tissue and blood, tumor
protein p53 [p53] expression, apoptosis with terminal deoxynucleotidyl transferase dUTP nick
end labeling [TUNEL] assay, apoptosis-related proteins B-cell lymphoma 2 [Bcl-2] and
Bcl2-associated X protein [Bax] using immunohistochemistry [IHC], proliferation with Ki-67
IHC, and expression levels of microtubule-associated variables, including tau protein, total
alpha- and beta-tubulin, and classes II-IV beta-tubulin isotopes with IHC.
OUTLINE: Patients receive eribulin mesylate 1.4 mg/m2 intravenously (IV) bolus over 2-5
minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
The purpose of this study is to assess the safety, feasibility, and performance of the C2
Focal Cryoablation Device in patients with Barrett's Esophagus (BE). At 6 to 8 weeks, the
patient will receive a follow-endoscopy to assess stricture formation along with biopsy
samples taken.
Post-operative pain will be noted. Additionally, biopsy samples will be evaluated for the
presence of residual Barrett's Esophagus. Through evaluation of the histological results,
treatment parameters for the ablation of human esophageal epithelium will be better
understood.
Evaluations include, but are not limited to the following:
- Deployment ease/scope compatibility.
- Device malfunctions.
- Time of catheter deployment.
- Adverse events.
- Stricture formation at 6 to 8 weeks.
- Patient Pain.
- Histological evaluation of treatment zone at 6 to 8 weeks for presence of residual
Barrett's Esophagus.
A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination With Doxorubicin vs. Doxorubicin Alone in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
TH-302 is designed to target the hypoxic regions of tumors which are generally located
distant from tumor vessels. Doxorubicin has poor tissue penetration and targets the regions
of tumors that are located in proximity to the tumor vessels. The presence of hypoxia in
solid tumors is associated with a more malignant phenotype and resistance to chemotherapy.
The hypoxia-activated prodrug, TH-302, is designed to selectively target the hypoxic
microenvironment. Soft tissue sarcomas have evidence supporting the presence of hypoxia based
on pO2 histography, F-MISO and gene expression profiling. There is an absence of therapeutic
options for subjects with soft tissue sarcoma. Combining doxorubicin with TH-302 may enable
the targeting of both the normoxic and hypoxic regions of soft tissue sarcoma.
A Phase 2 Study of ARQ 197 in Patients With Previously-Treated Malignant Mesothelioma
PRIMARY OBJECTIVES:
I. To determine the objective response rate of patients with malignant mesothelioma who are
treated with ARQ 197 (tivantinib).
SECONDARY OBJECTIVES:
I. To determine the progression-free survival of patients with malignant mesothelioma who are
treated with ARQ 197.
II. To determine the toxicity experienced by patients with malignant mesothelioma who are
treated with ARQ 197.
III. To determine median and overall survival of patients with malignant mesothelioma who are
treated with ARQ 197.
TERTIARY OBJECTIVES:
I. To determine the frequency of mesenchymal-epithelial transition (MET) gene amplification
in malignant mesothelioma patient tumor samples, and to correlate the results with MET
immunohistochemistry (IHC).
II. To determine whether MET gene amplification results in increased sensitivity to ARQ 197
as observed by improved clinical outcomes (response rate [RR] and progression free survival
[PFS]) compared to those without MET gene over-expression/amplification.
III. To determine whether high baseline serum hepatocyte growth factor (HGF), as well as
changes in serum HGF during treatment at pre-defined early time points, correlate with
treatment efficacy and clinical outcome, as measured by response rate and progression-free
survival.
IV. To identify mutations by sequencing of specific areas of the MET gene in tumor samples
(semaphorin [SEMA], jumonji [JM] and tyrosine kinase domains).
V. To perform immunohistochemistry (IHC) of mesothelioma tumors for HGF, MET and
phosphorylated (p)-MET (pY1003 and pY1230/34/35).
VI. To assess serum HGF and serum soluble MET levels by enzyme linked immunosorbent assay
(ELISA) (R&D systems) pre-treatment, after 2 cycles and at disease progression.
OUTLINE:
Patients receive tivantinib orally (PO) twice daily (BID). Treatment continues in the absence
of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
A Prospective, Phase III, Open-Label Study of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in HCV/HIV Coinfected Subjects
For HIV-1-infected individuals, HCV infection is a leading cause of morbidity and mortality,
and the prevalence of HCV infection is higher among those infected with HIV-1. At the time
the study was designed, the standard-of-care (SOC) therapy for HCV infection was treatment
with both PEG-IFN and RBV. This therapy is 40%-45% effective in patients with HCV infection
but is significantly less effective in patients with both HCV and HIV-1 (Shire et al. J Viral
Hepat., 2007). The purpose of this study was to evaluate the effectiveness of adding BOC (Kwo
et al. Lancet, 2010), an HCV protease inhibitor, to SOC therapy in treating HCV infection
(genotype 1) in HCV/HIV-1-coinfected adults.
Participants were enrolled into one of two groups based on previous HCV treatment experience.
1. Group A: HCV treatment-naive participants who had never received treatment with PEG-IFN
or experimental agents used to treat HCV, with or without RBV (N=170, refer to the note
below).
2. Group B: HCV treatment-experienced participants who had received any treatment with
standard interferon or with PEG-IFN with or without RBV, provided the last dose of
treatment was 90 days or more before study entry (N=140, refer to the note below).
Note: The team correspondence with the FDA led to an amendment to close enrollment in
December 2013, prior to the target sample sizes of 170 in Group A and 140 in Group B, as the
study power could be lowered while still meeting the key study objectives.
All participants had to be on stable antiretroviral therapy (ART) for at least 8 weeks prior
to study entry using a dual nucleos(t)ide reverse transcriptase inhibitor (NRTI) backbone
plus one of the following: efavirenz (EFV), raltegravir (RAL), lopinavir (LPV)/ritonavir
(RTV) 400/100 mg twice daily, atazanavir (ATV)/RTV, darunavir (DRV)/RTV 600/100 mg twice
daily OR must not have received any ART for at least 4 weeks immediately prior to entry.
Participation in this study lasted approximately 72 weeks.
HCV treatment-naive participants (Group A) were treated with PEG-IFN and RBV for 4 weeks
(lead-in). Then BOC was added to the treatment regimen (triple therapy). Cirrhotic
participants received 44 weeks of triple therapy. Among non-cirrhotics, the Week 8 HCV RNA
was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8
completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of
triple therapy followed by 12 additional weeks of double-drug therapy with PEG-IFN/RBV. HCV
treatment-experienced participants (Group B) also had a lead-in followed by 32 weeks of
triple therapy and 12 weeks of PEG-IFN/RBV double therapy if non-cirrhotic, or by 44 weeks of
triple therapy if cirrhotic.
Treatment was to be discontinued due to HCV virologic failure if:
1. HCV RNA ≥100 IU/mL at Week 12,
2. detectable HCV RNA at Week 24, or
3. confirmed HCV RNA >1000 IU/mL any time after Week 12.
Undetectable HCV RNA was defined as below the lower limit of quantification (LLOQ) and target
not detected (TND) by Roche COBAS® TaqMan® HCV Test v2.0.
Study visits were scheduled at screening and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28
for both study groups. Group A participants who completed treatment at Week 28 had further
study visits at Weeks 40, 52, 60, and 72. Participants who were prescribed 48-weeks of
therapy (Group A and Group B) had further study visits at Weeks 32, 36, 40, 44, 48, 60, and
72. At each visit, a physical examination and blood collection were conducted. Participants
also completed an HCV treatment adherence questionnaire. Select visits included urine
collection and pregnancy testing (for women of reproductive potential). Plasma, serum, and
peripheral blood mononuclear cells (PBMCs) were be stored for use in future studies. After
experiencing HCV virologic failure as defined above or premature treatment discontinuation
due to safety or other reasons, participants were followed on a separate schedule of events
with visits every 12 weeks from Week 24 to 72. The evaluations at these follow-up visits were
limited to safety evaluations and stored plasma/serum sample collection.
The A5294 study consisted of single-arm evaluations to assess the efficacy of BOC added to
PEG-IFN/RBV in the two study populations:
1. HCV treatment-naive participants (Group A)
2. HCV treatment-experienced participants (Group B).
The two study populations were addressed together in this single trial - rather than in two
separate trials - mainly for administrative efficiency. The analyses were conducted
separately for each Study Group. The study was not designed for comparison. The pooled
summaries for Baseline Characteristics provided in the Results Section in this record were
prepared solely for the ClinicalTrials.gov results submission.
Pilot Study for Evaluation of Glatiramer Acetate in RRMS Patients With Comorbid Autoimmune Conditions
Multiple Sclerosis (MS) is an auto-immune neurodegenerative disease that affects more than
400,000 individuals in the United States, and 2.5 million worldwide
(www.nationalmssociety.org). The main pathogenic mechanism in MS involves an inflammatory
condition that damages the myelin of the central nervous system (CNS), resulting in axonal
damage and neurological impairment, often leading to severe disability. MS is one of the
most common causes of neurological disability in young and middle-aged adult individuals,
and as such has a tremendous physical, psychological and social impact on patients' lives.
MS is a complex disease diagnosed by McDonald criteria with different clinical and
pathological phenotypes. Several forms of MS have been described: Relapsing-Remitting
(RRMS), Secondary-Progressive MS (SPMS), Progressive-Relapsing MS (PRMS), and
Primary-Progressive MS (PPMS).
Glatiramer Acetate (GA) and Beta-Interferons (β-IFNs) are well established first-line
immunomodulating treatment options for relapsing remitting multiple sclerosis (RRMS) with
excellent safety profiles. The mechanisms of action of GA and IFNs are different. It is well
known that in general Disease-Modifying Treatments (DMTs) reduce relapse rate in more than
half of the multiple sclerosis (MS) patients who receive DMT, while having little if any
effect on the rest. It has been speculated that the response to beta-interferons or GA may
have genetic basis. As Axtell RC et al. indicated the experimental autoimmune
encephalomyeilits (EAE) in mouse caused by TH1 cells generally respond well to
interferon-beta, while EAE caused by TH17 cells get worse with interferon-beta.
Autoimmune disease is an extreme situation where the autoimmune response overshoots and goes
out of control. The other extreme is a degenerative disorder, where the autoimmune response
is not strong enough for effective protection, and degeneration therefore continues. GA
being an immunomodulator may provide both properly regulated immune suppression (in the case
of autoimmune disease) and properly regulated immune activation (in the case of the
neurodegenerative disease).
Autoimmune conditions cluster in families with high risk for multiple sclerosis than in
general population which suggests that the disease might arise on a background of a
generalized susceptibility to autoimmunity. Occurrence of psoriasis, autoimmune thyroiditis,
vasculitis, rheumatoid arthritis, scleroderma, lupus are seen more commonly in MS patients.
Many of these patients initially get started on beta-IFNs, and usually do not do well on
them. According to Investigator's and the USC MS Comprehensive Care Center experience,
autoimmune co-morbidity associated with MS can serve as a biological marker predicting good
response to GA and unfavorable response to the IFNs.
Phase II Study of Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy
Induction will consist of tretinoin 45 mg/m2 po daily (rounded up to the nearest 10mg) in two
divided doses (25 mg/m2 in patients <20 years of age) for 35 days and ATO 0.15 mg/kg IV daily
for 35 doses given 5-7 days per week. The drugs will then be discontinued, and the patient
will be followed until a clinical complete remission is achieved. Idarubicin 12 mg/m2 IV for
4 doses will be added during induction on day 2 if the presenting WBC is >10,000/μl, or if
the WBC increases to 5,000/μl on day 5, 10,000/μl on day 10, or 15,000/μl on day 15, because
of the increased risk of the APL differentiation syndrome and relapse in these patients.
Dexamethasone 10 mg twice daily with be given on days 1-14 of induction as prophylaxis for
the APL differentiation syndrome. All patients will then receive four courses of
consolidation with tretinoin 45 mg/m2 po daily (rounded up to the nearest 10mg) (25 mg/m2 in
patients <20 years of age) for 15 days and ATO 0.15 mg/kg IV for 25 doses.
Patients with high-risk disease or who received Idarubicin during Induction may receive
intrathecal cytarabine as CNS prophylaxis given by the treating physician during
consolidation, at the discretion of the site PI. High-risk patients will also receive
maintenance therapy with additional courses of tretinoin and ATO every 3 months for 2 years.
Each maintenance course will consist of tretinoin 45 mg/m2 po daily (25 mg/m2 in patients <20
years of age) for 15 days and ATO 0.15 mg/kg IV for 10 doses. Disease status will be
monitored with serial analyses of peripheral blood samples using RT-PCR for PML-RARα mRNA.
Patients will be followed until relapse, death, loss to follow-up, or removal from study.
Induction therapy can be given as an inpatient or outpatient. Consolidation and maintenance
treatments will be given as an outpatient. Consolidation may also be given at the patient's
local institution. Intrathecal cytarabine treatments will be administered as an outpatient.
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