Trial Outcomes & Findings for Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia (NCT NCT00098371)

NCT ID: NCT00098371

Last Updated: 2016-10-24

Results Overview

CR requires all of the following for at least two months from completion of therapy: Absence of lymphadenopathy in excess of 1 cm on physical exam; No hepatomegaly or splenomegaly on physical exam; Absence of constitutional symptoms; Normal CBC (complete blood count) as exhibited by polymorphonuclear leukocytes \> 1500/µL, platelets \> 100,000/µL, hemoglobin \> 11.0 g/dl (untransfused); lymphocyte count \< 5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with \< 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 64 participants
• Primary outcome timeframe: Up to 8 months
• Results posted on: 2016-10-24

Participant Flow

Participant milestones

Measure	Treatment (Alvocidib) Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.To improve tolerability of treatment regimen, an amendment to the protocol was done to reduce the cycle length from 42 days to 28 days, reducing the number of treatments per cycle from four (days 1, 8, 15 \& 22) to three (days 1, 8, and 15).
Overall Study STARTED	64
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia

Baseline characteristics by cohort

Measure	Treatment (Alvocidib) n=64 Participants Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 months

Population: Patients were assessed for clinical response after two, four and six cycles.

CR requires all of the following for at least two months from completion of therapy: Absence of lymphadenopathy in excess of 1 cm on physical exam; No hepatomegaly or splenomegaly on physical exam; Absence of constitutional symptoms; Normal CBC (complete blood count) as exhibited by polymorphonuclear leukocytes > 1500/µL, platelets > 100,000/µL, hemoglobin > 11.0 g/dl (untransfused); lymphocyte count < 5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with < 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent.

Outcome measures

Measure	Treatment (Alvocidib) n=64 Participants Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.	Group 2 Patients with dexamethasone	Patients With Del(11q22.3)	Patients Without Del(11q22.3)	Patients With Complex Karyotype Complex Karyotype defined as three or more cytogenetic aberrations.	Patients Without Complex Karyotype Complex Karyotype defined as fewer than three cytogenetic aberrations.
Complete Response (CR) Rate	2 percent of patients	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 8 months

Population: Schedule was amended (cycle length) from 42 to 28 days, reduction in the number of doses per cycle from 4 to 3 and administration of prophylactic dexamethasone 20 mg IV on each treatment day.

CR requires all of the following: Absence of lymphadenopathy in excess of 1 cm on physical exam; No hepatomegaly or splenomegaly on physical exam; Absence of constitutional symptoms; Normal CBC as exhibited by polymorphonuclear leukocytes > 1500/µL, platelets > 100,000/µL, hemoglobin > 11.0 g/dl (untransfused); lymphocyte count < 5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with < 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. Patients with CR after induction but wih treatment-related persistent cytopenia is a PR. PR requires a > 50% decrease in peripheral lymphocyte count from pretreatment value, > 50% reduction in lymphadenopathy, and/or > 50% reduction in splenomegaly/hepatomegaly. These patients must have one of the following: polymorphonuclear leukocytes > 1,500/μL , platelets > 100,000/μL, hemoglobin > 11.0 g/dl (untransfused) or any with 50% improvement from pretreatment value.

Outcome measures

Measure	Treatment (Alvocidib) n=64 Participants Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.	Group 2 Patients with dexamethasone	Patients With Del(11q22.3)	Patients Without Del(11q22.3)	Patients With Complex Karyotype Complex Karyotype defined as three or more cytogenetic aberrations.	Patients Without Complex Karyotype Complex Karyotype defined as fewer than three cytogenetic aberrations.
Overall Response Rate (CR + PR)	53 percent of patients Interval 41.0 to 65.0	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 8 months

Population: Duration of response was not collected for patients.

Response evaluation criteria based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response. Descriptive statistics will be computed (median, range, mean, standard deviation, minimum, and maximum) on response duration.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 5 years

PFS was calculated from the date of study entry until time of disease progression or death, whichever came first, censoring patients alive and relapse free at last follow up. Patients who withdrew from study to undergo an allogeneic SCT (Stem cell transplantation) were censored at the time of transplantation.

Outcome measures

Measure	Treatment (Alvocidib) n=34 Participants Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.	Group 2 Patients with dexamethasone	Patients With Del(11q22.3)	Patients Without Del(11q22.3)	Patients With Complex Karyotype Complex Karyotype defined as three or more cytogenetic aberrations.	Patients Without Complex Karyotype Complex Karyotype defined as fewer than three cytogenetic aberrations.
Progression-free Survival (PFS) for Responding Patients as Assessed Using Standard Kaplan-Meier Methods	12 months Interval 8.5 to 13.1	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 5 years

PFS was calculated from the date of study entry until time of disease progression or death, whichever came first, censoring patients alive and relapse free at last follow up. Patients who withdrew from study to undergo an allogeneic SCT were censored at the time of transplantation.

Outcome measures

Measure	Treatment (Alvocidib) n=64 Participants Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.	Group 2 Patients with dexamethasone	Patients With Del(11q22.3)	Patients Without Del(11q22.3)	Patients With Complex Karyotype Complex Karyotype defined as three or more cytogenetic aberrations.	Patients Without Complex Karyotype Complex Karyotype defined as fewer than three cytogenetic aberrations.
Progression-free Survival for All Patients as Assessed Using Standard Kaplan-Meier Methods	8.6 months Interval 6.7 to 12.6	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 5 years

Overall survival data will be reported on a 3-month basis for 5 years

Outcome measures

Measure	Treatment (Alvocidib) n=64 Participants Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.	Group 2 Patients with dexamethasone	Patients With Del(11q22.3)	Patients Without Del(11q22.3)	Patients With Complex Karyotype Complex Karyotype defined as three or more cytogenetic aberrations.	Patients Without Complex Karyotype Complex Karyotype defined as fewer than three cytogenetic aberrations.
Overall Survival	28.8 months Interval 18.6 to 32.9	—	—	—	—	—

PRIMARY outcome

Timeframe: Measurement prior to each infusion, at end of therapy, 2 months post-completion and post-treatment follow-up every 3 months for two years.

Population: Grade 3 to 4 infections requiring IV antibiotics and were generally related to upper or lower respiratory infections or infections of indwelling central venous catheters.

Toxicity determination based on NCI Common Toxicity Criteria version 3 and modified NCI Common toxicity guidelines for evaluating hematologic toxicity in leukemia.

Outcome measures

Measure	Treatment (Alvocidib) n=64 Participants Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.	Group 2 Patients with dexamethasone	Patients With Del(11q22.3)	Patients Without Del(11q22.3)	Patients With Complex Karyotype Complex Karyotype defined as three or more cytogenetic aberrations.	Patients Without Complex Karyotype Complex Karyotype defined as fewer than three cytogenetic aberrations.
Toxicity	25 percentage of patients	—	—	—	—	—

SECONDARY outcome

Timeframe: During treatment day 1 and day 8 of cycle 1

Population: The values are overall averages for all patients on days 1 and 8 - therefore, there is only a single value for each parameter.

Pharmacokinetics were performed on day 1 and day 8 of cycle 1 by plasma levels of both flavopiridol and metabolites of flavopiridol using Area Under the Curve (AUC)

Outcome measures

Measure	Treatment (Alvocidib) n=63 Participants Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.	Group 2 Patients with dexamethasone	Patients With Del(11q22.3)	Patients Without Del(11q22.3)	Patients With Complex Karyotype Complex Karyotype defined as three or more cytogenetic aberrations.	Patients Without Complex Karyotype Complex Karyotype defined as fewer than three cytogenetic aberrations.
Pharmacokinetics (PK) (AUC) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol	9.42 μM*hr Standard Deviation 5.11	—	—	—	—	—

SECONDARY outcome

Timeframe: During treatment day 1 and day 8 of course 1

Population: The values are overall averages for all patients on days 1 and 8 - therefore, there is only a single value for each parameter.

Pharmacokinetics were performed on day 1 and day 8 of cycle 1 by plasma levels of both flavopiridol and metabolites of flavopiridol

Outcome measures

Measure	Treatment (Alvocidib) n=63 Participants Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.	Group 2 Patients with dexamethasone	Patients With Del(11q22.3)	Patients Without Del(11q22.3)	Patients With Complex Karyotype Complex Karyotype defined as three or more cytogenetic aberrations.	Patients Without Complex Karyotype Complex Karyotype defined as fewer than three cytogenetic aberrations.
PK (Cmax) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol	2.04 μM Standard Deviation 1.05	—	—	—	—	—

SECONDARY outcome

Timeframe: Urine collected at 4 separate times in some patients during the first 24 hours after start of infusion on day 1 of course 1.

Population: Data for this PK analysis was not collected and analyzed.

urine samples were collected in some patients during the first 24 hours after the start of the infusion on cycle 1, day 1 to isolate metabolites of flavopiridol to be used as internal standard for plasma metabolite quantification experiments.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4.5 hours, 8 hours, 12 hours, and 24 hours following the initiation of therapy during day 1 of course 1

Population: IL-6 expression analysis was available for only day 1 and not day 8.

IL-6 measures were adjusted for baseline values

Outcome measures

Measure	Treatment (Alvocidib) n=26 Participants Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.	Group 2 n=31 Participants Patients with dexamethasone	Patients With Del(11q22.3)	Patients Without Del(11q22.3)	Patients With Complex Karyotype Complex Karyotype defined as three or more cytogenetic aberrations.	Patients Without Complex Karyotype Complex Karyotype defined as fewer than three cytogenetic aberrations.
Serial Levels of IL-6 as Assessed by Blood Plasma 4.5 hours	3.5 pg/ml Interval 2.7 to 4.6	1.6 pg/ml Interval 1.2 to 2.0	—	—	—	—
Serial Levels of IL-6 as Assessed by Blood Plasma 8 hours	13.4 pg/ml Interval 9.8 to 18.4	2.2 pg/ml Interval 1.7 to 2.9	—	—	—	—
Serial Levels of IL-6 as Assessed by Blood Plasma 12 hours	25.5 pg/ml Interval 17.3 to 37.6	2.5 pg/ml Interval 1.8 to 3.6	—	—	—	—
Serial Levels of IL-6 as Assessed by Blood Plasma 24 hours	13.2 pg/ml Interval 8.0 to 21.7	3.9 pg/ml Interval 2.5 to 6.2	—	—	—	—

SECONDARY outcome

Timeframe: At baseline and at time of relapse or when patient goes off therapy due to disease progression

Population: Data for this outcome as not collected and analyzed

Samples will be examined for ex vivo sensitivity to flavopiridol, expression of select anti-apoptosis proteins, BCRP mRNA and protein expression, difference in gene expression by cDNA microarray and potentially by epigenetic arrays. Comparisons will be used to evaluate mechanisms of acquired flavopiridol resistance.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 8 months

Population: Data were not collected and analyzed for VH mutational status, ZAP-70 protein expression, CD38, and p53

overall response rates (CR+PR)

Outcome measures

Measure	Treatment (Alvocidib) n=21 Participants Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.	Group 2 n=43 Participants Patients with dexamethasone	Patients With Del(11q22.3) n=28 Participants	Patients Without Del(11q22.3) n=36 Participants	Patients With Complex Karyotype n=27 Participants Complex Karyotype defined as three or more cytogenetic aberrations.	Patients Without Complex Karyotype n=37 Participants Complex Karyotype defined as fewer than three cytogenetic aberrations.
Correlation of Adverse Prognostic Factors With Response to Flavopiridol Treatment as Assessed by Interphase Cytogenetics, VH Mutational Status, ZAP-70 Protein Expression, CD38, and p53	57 percentage of patients in each subgroup	51 percentage of patients in each subgroup	50 percentage of patients in each subgroup	56 percentage of patients in each subgroup	48 percentage of patients in each subgroup	57 percentage of patients in each subgroup

SECONDARY outcome

Timeframe: At baseline, 4.5 hours (end of continuous infusion), 8 hours, and approximately 24 hours following initiation of therapy

Population: Data was not collected and analyzed for this outcome

Assessed by real time RT-PCR (mcl-1, HIF-1alpha), immunoblot analysis (mcl-1, HIF-1alpha, I-kappaB, I-kappaB phosphorylation, targets of IL-6), and electrophoretic mobility shift analysis (NF-kappaB activation)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline

Population: A subset of patients who had sufficient material were analyzed according to response only.

CLL cells will be incubated with control or flavopiridol (1 or 2.8 microMolar) for 4-hours followed by a 20 hours in media with 10% heat-inactivated human serum. Assessment of apoptosis following exposure of human CLL cells will be performed using annexin/PI flow cytometry. Patient samples with greater than 50% live cells (annexin-/PI-) following exposure to 2.8 microMolar flavopiridol will be considered to have insensitive disease. Patients whose CLL cells have less than 50% live cells at 1 microMolar will be considered to have highly sensitive disease.

Outcome measures

Measure	Treatment (Alvocidib) n=9 Participants Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.	Group 2 n=4 Participants Patients with dexamethasone	Patients With Del(11q22.3)	Patients Without Del(11q22.3)	Patients With Complex Karyotype Complex Karyotype defined as three or more cytogenetic aberrations.	Patients Without Complex Karyotype Complex Karyotype defined as fewer than three cytogenetic aberrations.
Comparison of Clinical Response and Tumor Lysis in Vivo With Drug-induced Apoptosis and Mitochondrial Perturbation in Vitro as Assessed by Flow Cytometry	22.2 percentage of priming cells Standard Deviation 16.5	6.4 percentage of priming cells Standard Deviation 4.3	—	—	—	—

Adverse Events

Treatment (Alvocidib)

Serious events: 4 serious events

Other events: 64 other events

Deaths: 0 deaths

Serious adverse events

Measure

Treatment (Alvocidib) n=64 participants at risk Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.

Infections and infestations Infection

6.2% 4/64 • Number of events 4 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.

Other adverse events

Measure	Treatment (Alvocidib) n=64 participants at risk Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for \> 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
Investigations Neutropenia	96.9% 62/64 • Number of events 62 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.
Blood and lymphatic system disorders Anemia	59.4% 38/64 • Number of events 38 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.
Injury, poisoning and procedural complications Thrombocytopenia	65.6% 42/64 • Number of events 42 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.
General disorders Fatigue	93.8% 60/64 • Number of events 60 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.
Gastrointestinal disorders Diarrhea	93.8% 60/64 • Number of events 60 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.
Gastrointestinal disorders Nausea and Vomiting	75.0% 48/64 • Number of events 48 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.
Metabolism and nutrition disorders Anorexia	31.2% 20/64 • Number of events 20 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.
Psychiatric disorders Anxiety/Depression	17.2% 11/64 • Number of events 11 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.
Metabolism and nutrition disorders Tumor Lysis Syndrome	43.8% 28/64 • Number of events 28 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.
Immune system disorders Cytokine Release Syndrome	42.2% 27/64 • Number of events 27 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.
Investigations Transaminitis	92.2% 59/64 • Number of events 59 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.
Investigations Hyperbilirubinemia	23.4% 15/64 • Number of events 15 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.
Infections and infestations Infection	67.2% 43/64 • Number of events 43 NCI Common Toxicity Criteria of Adverse Events (version 3) and modified NCI Common Toxicity Criteria guidelines for evaluating hematologic toxicity for leukemia was used to grade adverse events for patients. Adverse events are reported across all grades.

Additional Information

John Byrd, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-9869

Email: John.Byrd@osumc.edu

Results disclosure agreements

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

Restriction type: LTE60