TriangleNCT00112723 · STUDY IN CONTEXT
Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma
Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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
Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy.
The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.
Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria.
The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients.
Identify subsets, based on levels of response (PR and SD), of lymphoid / plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of flavopiridol.
Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.
Reported safety
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-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- trial label
- Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent 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
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0000
- source section id
- NCT00112723-om-0000
- source outcome index
- 0
- endpoint
- Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)
- endpoint definition
- Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy.
- time origin
- 28 days
- 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-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0001
- source section id
- NCT00112723-om-0001
- source outcome index
- 1
- endpoint
- Maximum Tolerated Dose (MTD)
- endpoint definition
- The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.
- time origin
- 28 days
- 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-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0002
- source section id
- NCT00112723-om-0002
- source outcome index
- 2
- endpoint
- Complete and Partial Response Rate (Phase II)
- endpoint definition
- Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria.
- time origin
- Up to 2 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Includes patients enrolled with Indolent B-cell NHL, Intermediate Grade B NHL, Mantle cell NHL and T/NK-cell NHL
- 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-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0003
- source section id
- NCT00112723-om-0003
- source outcome index
- 3
- endpoint
- Qualitative and Quantitative Toxicities in Regard to Organ Specificity
- endpoint definition
- The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients.
- time origin
- Up to 30 days after completion of study treatment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Grade 3 and 4 toxicities.
- 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-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0004
- source section id
- NCT00112723-om-0004
- source outcome index
- 4
- endpoint
- Lymphoid/Plasma Cell Malignancies
- endpoint definition
- Identify subsets, based on levels of response (PR and SD), of lymphoid / plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of flavopiridol.
- time origin
- Up to 2 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Response indicated for Indolent B-cell NHL, Mantle cell NHL and T-cell NHL
- 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-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0005
- source section id
- NCT00112723-om-0005
- source outcome index
- 5
- endpoint
- Pharmacokinetics (Area Under the Curve; AUC) of Flavopiridol
- endpoint definition
- Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.
- time origin
- 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- total of 71 PK (Pharmacokinetic) profiles comprising 484 plasma concentration were determined for 45 of 46 patients following treatment
- 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-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)
- regimen
- PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112723-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)
- regimen
- PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112723-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)
- regimen
- PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112723-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Dose Level 1 (30+30)
- regimen
- PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112723-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Level 2 (30+50)
- regimen
- PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112723-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Level 3 (50+50)
- regimen
- PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112723-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)
- regimen
- Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112723-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)
- regimen
- Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112723-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2)
- regimen
- Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112723-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Dose Levels 1, 2, 3
- regimen
- Dose Level 1 (30 mg/m2 + 30 mg/m2), Dose Level 2 (30 mg/m2 + 50 mg/m2), Dose Level 3 (50 mg/m2 + 50 mg/m2) PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112723-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Cohort 1
- regimen
- Patients diagnosed with Indolent B-cell NHL
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112723-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Cohort 2
- regimen
- Patients diagnosed with Mantle Cell NHL
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112723-om-0004#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00112723
- harm key
- EG000
- source section id
- NCT00112723-ae
- event group key
- EG000
- event group label
- Treatment (Alvocidib)
- serious affected
- 0
- serious at risk
- 35
- other affected
- 34
- other at risk
- 35
- frequency threshold
- 5
- collection period
- Patients were assessed for clinical response after two, four and six cycles with laboratory studies, physical exam, and CT scans.
- event definition
- NCI Common Toxicity Criteria for Adverse Events (version 3.0) was used to define and grade toxicity.
- 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