Trial Outcomes & Findings for Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma (NCT NCT00058240)
NCT ID: NCT00058240
Last Updated: 2017-07-02
Results Overview
DLTs were defined as non-hematologic toxicity of grade 3 or greater severity (excluding transient liver function abnormalities, transient electrolyte abnormalities that are not life threatening, fatigue, or diarrhea that resolve within 4 days), or in some case grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity). Hematologic toxicity were evaluated by the modified NCI criteria and followed closely. Dose limiting only if grade 4 thrombocytopenia or neutropenia persists for 7 days or greater. Inability to continue with cycle 2 by 7 weeks for reasons other than progression of disease will also be considered a DLT.The National Cancer Institute Common Toxicity Criteria will be used to characterize toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
up to 7 weeks
Results posted on
2017-07-02
Participant Flow
Patients with relapsed, symptomatic Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) were enrolled and received treatment between May 2003 and February 2006
Participant milestones
| Measure |
Dose Level 1
Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
|
Dose Level 2
Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
|
Dose Level 3
Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
Dose Level 4
Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
|---|---|---|---|---|
|
First Dose Level
STARTED
|
20
|
3
|
17
|
12
|
|
First Dose Level
Treated
|
20
|
3
|
17
|
12
|
|
First Dose Level
COMPLETED
|
20
|
3
|
17
|
12
|
|
First Dose Level
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Dose Level
STARTED
|
0
|
0
|
2
|
4
|
|
Second Dose Level
COMPLETED
|
0
|
0
|
2
|
4
|
|
Second Dose Level
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=20 Participants
Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
|
Dose Level 2
n=3 Participants
Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles.
|
Dose Level 3
n=17 Participants
Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
Dose Level 4
n=12 Participants
Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.5 years
n=5 Participants
|
52 years
n=7 Participants
|
55 years
n=5 Participants
|
60 years
n=4 Participants
|
60 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 patients
n=5 Participants
|
3 patients
n=7 Participants
|
17 patients
n=5 Participants
|
12 patients
n=4 Participants
|
52 patients
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 7 weeksDLTs were defined as non-hematologic toxicity of grade 3 or greater severity (excluding transient liver function abnormalities, transient electrolyte abnormalities that are not life threatening, fatigue, or diarrhea that resolve within 4 days), or in some case grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity). Hematologic toxicity were evaluated by the modified NCI criteria and followed closely. Dose limiting only if grade 4 thrombocytopenia or neutropenia persists for 7 days or greater. Inability to continue with cycle 2 by 7 weeks for reasons other than progression of disease will also be considered a DLT.The National Cancer Institute Common Toxicity Criteria will be used to characterize toxicity.
Outcome measures
| Measure |
Dose Level 1
n=20 Participants
Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
|
Dose Level 2
n=3 Participants
Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
|
Dose Level 3
n=19 Participants
Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
Dose Level 4
n=16 Participants
Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
|---|---|---|---|---|
|
Number of Patients With Dose Limiting Toxicities (DLTs)
|
2 patients
|
2 patients
|
4 patients
|
3 patients
|
PRIMARY outcome
Timeframe: Up to 6 weeksRecommended dose determined by number of DLTs \[non-hematologic toxicity grade 3 or greater (excluding not life-threatening transient liver function or transient electrolyte abnormalities, fatigue, or diarrhea resolving within 4 days), some grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity), hematologic toxicity of grade 4 thrombocytopenia/neutropenia persisting for 7 days or greater, or inability to continue cycle 2 by 7 weeks for reasons other than disease progression\] and consideration of number of patients with severe tumor lysis requiring hemodialysis with dose 1.
Outcome measures
| Measure |
Dose Level 1
n=16 Participants
Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
|
Dose Level 2
Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
|
Dose Level 3
Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
Dose Level 4
Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
|---|---|---|---|---|
|
Recommended Dose Level of Flavopiridol
Cycle 1 dose 1
|
30 mg/m^2
|
—
|
—
|
—
|
|
Recommended Dose Level of Flavopiridol
Cycle 1 dose 2 thru Cycle 6
|
50 mg/m^2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Dose Level 1
n=52 Participants
Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
|
Dose Level 2
Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
|
Dose Level 3
Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
Dose Level 4
Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
|---|---|---|---|---|
|
Overall Response Rate (CR + PR) of Flavopiridol in Patients Evaluated Utilizing the Revised National Cancer Institute-sponsored Working Group Guidelines
|
21 patients
|
—
|
—
|
—
|
Adverse Events
Dose Levels 1-3
Serious events: 11 serious events
Other events: 40 other events
Deaths: 0 deaths
Dose Level 4
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Levels 1-3
n=40 participants at risk；n=42 participants at risk
Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
Dose Level 4
n=16 participants at risk
Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperacute Tumor Lysis
|
26.2%
11/42 • Number of events 11 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
6.2%
1/16 • Number of events 1 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
Other adverse events
| Measure |
Dose Levels 1-3
n=40 participants at risk；n=42 participants at risk
Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
Dose Level 4
n=16 participants at risk
Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
|
|---|---|---|
|
Investigations
Absolute Neutrophil Count
|
75.0%
30/40 • Number of events 30 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
100.0%
16/16 • Number of events 16 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Investigations
WBC
|
0.00%
0/40 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
68.8%
11/16 • Number of events 11 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Investigations
Platelets
|
37.5%
15/40 • Number of events 15 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
43.8%
7/16 • Number of events 7 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Vascular disorders
Hemorhage
|
7.5%
3/40 • Number of events 3 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
6.2%
1/16 • Number of events 1 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Vascular disorders
Hypotension
|
10.0%
4/40 • Number of events 4 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
6.2%
1/16 • Number of events 1 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
15.0%
6/40 • Number of events 6 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
18.8%
3/16 • Number of events 3 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
16/40 • Number of events 16 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
75.0%
12/16 • Number of events 12 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
5.0%
2/40 • Number of events 2 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
6.2%
1/16 • Number of events 1 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Investigations
AST SGOT(serum glutamic oxaloacetic transaminase) or ALT, SGPT (serum glutamic pyruvic transaminase)
|
32.5%
13/40 • Number of events 13 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
18.8%
3/16 • Number of events 3 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Investigations
Bilirubin
|
7.5%
3/40 • Number of events 3 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
6.2%
1/16 • Number of events 1 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Renal and urinary disorders
Renal Failture
|
2.5%
1/40 • Number of events 1 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
6.2%
1/16 • Number of events 1 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Musculoskeletal and connective tissue disorders
Pain
|
2.5%
1/40 • Number of events 1 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
6.2%
1/16 • Number of events 1 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
1/40 • Number of events 1 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
6.2%
1/16 • Number of events 1 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
4/40 • Number of events 4 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
25.0%
4/16 • Number of events 4 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Infections and infestations
Infection w/neutropenia
|
17.5%
7/40 • Number of events 7 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
37.5%
6/16 • Number of events 6 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
General disorders
Fatigue
|
20.0%
8/40 • Number of events 8 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
12.5%
2/16 • Number of events 2 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
|
Metabolism and nutrition disorders
Biochemical tumor lysis
|
57.5%
23/40 • Number of events 23 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
43.8%
7/16 • Number of events 7 • Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
|
Additional Information
John Byrd, MD
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-3196
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60