Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Source null

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primary · POSTED

Recommended 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.

Source null

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secondary · POSTED

Per 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

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id: NCT00058240
trial label: Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
applicability: unclear
applicability note: Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 3
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id
NCT00058240
outcome key
om-0000
source section id
NCT00058240-om-0000
source outcome index
0
endpoint
Number of Patients With Dose Limiting Toxicities (DLTs)
endpoint definition
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.
time origin
up to 7 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id
NCT00058240
outcome key
om-0001
source section id
NCT00058240-om-0001
source outcome index
1
endpoint
Recommended Dose Level of Flavopiridol
endpoint definition
Recommended 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.
time origin
Up to 6 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id
NCT00058240
outcome key
om-0002
source section id
NCT00058240-om-0002
source outcome index
2
endpoint
Overall Response Rate (CR + PR) of Flavopiridol in Patients Evaluated Utilizing the Revised National Cancer Institute-sponsored Working Group Guidelines
endpoint definition
Per 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
time origin
Up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id
NCT00058240
outcome key
om-0000
arm key
OG000
arm label
Dose Level 1
regimen
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
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00058240-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id
NCT00058240
outcome key
om-0000
arm key
OG001
arm label
Dose Level 2
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00058240-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id
NCT00058240
outcome key
om-0000
arm key
OG002
arm label
Dose Level 3
regimen
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
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00058240-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id
NCT00058240
outcome key
om-0000
arm key
OG003
arm label
Dose Level 4
regimen
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
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00058240-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id
NCT00058240
outcome key
om-0001
arm key
OG000
arm label
Dose Level 4
regimen
Flavopiridol was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour beginning Dose Level 2 Cycle 1 for 6 Cycles.
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00058240-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id
NCT00058240
outcome key
om-0002
arm key
OG000
arm label
Dose Level 1, 2, 3, 4
regimen
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
analyzed count
52
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00058240-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id
NCT00058240
harm key
EG000
source section id
NCT00058240-ae
event group key
EG000
event group label
Dose Levels 1-3
serious affected
11
serious at risk
42
other affected
40
other at risk
40
frequency threshold
5
collection period
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.
event definition
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id
NCT00058240
harm key
EG001
source section id
NCT00058240-ae
event group key
EG001
event group label
Dose Level 4
serious affected
1
serious at risk
16
other affected
16
other at risk
16
frequency threshold
5
collection period
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.
event definition
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice