TriangleNCT01326702 · STUDY IN CONTEXT
Veliparib, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory Lymphoma, Multiple Myeloma, or Solid Tumors
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
Maximum Tolerated Dose (MTD) reflects the highest dose of Veliparib when combined with Bendamustine Hydrochloride that did not cause a DLT. The maximum tolerated dose (MTD) was defined as the highest dose level at which 33% of patients experienced DLT.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.
Adverse events assessed by NCI CTCAE version 4.0 (Phase Ib) See adverse events section.
Summary statistics will be used for CR. Responses will be evaluated by the International Uniform Response Criteria for Multiple Myeloma.
Duration of Remission (Phase IIa)
Kaplan-Meier estimates will be calculated and log-rank tests will be employed when certain comparisons are needed.
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-hairy-cell-leukemia
- nct id
- NCT01326702
- trial label
- Veliparib, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory Lymphoma, Multiple Myeloma, or Solid Tumors
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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
- 7
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0000
- source section id
- NCT01326702-om-0000
- source outcome index
- 0
- endpoint
- Maximum Tolerated Dose of Veliparib When Combined With Bendamustine Hydrochloride
- endpoint definition
- Maximum Tolerated Dose (MTD) reflects the highest dose of Veliparib when combined with Bendamustine Hydrochloride that did not cause a DLT. The maximum tolerated dose (MTD) was defined as the highest dose level at which 33% of patients experienced DLT.
- time origin
- 28 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The MTD was established at Dose Level 6 Veliparib 300mg PO BID plus Bendamustine 90 mg/m2
- 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-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0001
- source section id
- NCT01326702-om-0001
- source outcome index
- 1
- endpoint
- Response Rate
- endpoint definition
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.
- time origin
- 2 years
- 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-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0002
- source section id
- NCT01326702-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Adverse Events
- endpoint definition
- Adverse events assessed by NCI CTCAE version 4.0 (Phase Ib) See adverse events section.
- time origin
- 2 years
- 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-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0003
- source section id
- NCT01326702-om-0003
- source outcome index
- 3
- endpoint
- Complete Response (CR) to Study Treatment (Phase IIa)
- endpoint definition
- Summary statistics will be used for CR. Responses will be evaluated by the International Uniform Response Criteria for Multiple Myeloma.
- time origin
- 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Dose Level 7; Bendamustine 90mg/m2, ABT-888 400mg BID Participants treated on Dose Level 7 make up the cohort expansion of VBR in participants with CD20+ B-cell lymphoma.
- 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-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0004
- source section id
- NCT01326702-om-0004
- source outcome index
- 4
- endpoint
- Duration of Remission (Phase IIa)
- endpoint definition
- Duration of Remission (Phase IIa)
- time origin
- From the first documented response to the first documented progression or death, assessed up to 30 days post-treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data were not collected
- 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-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0005
- source section id
- NCT01326702-om-0005
- source outcome index
- 5
- endpoint
- Overall Survival (Phase IIa)
- endpoint definition
- Kaplan-Meier estimates will be calculated and log-rank tests will be employed when certain comparisons are needed.
- time origin
- Up to 30 days post-treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data were not collected
- 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-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0000
- arm key
- OG000
- arm label
- All Study Participants
- regimen
- All Study Participants
- analyzed count
- 43
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01326702-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg
- regimen
- Bendamustine 70 mg/m2, ABT-888 50 mg
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01326702-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
- regimen
- Bendamustine 90 mg/m2, ABT-888 50 mg
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01326702-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
- regimen
- Bendamustine 90 mg/m2, ABT-888 100 mg BID
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01326702-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
- regimen
- Bendamustine 90 mg/m2, ABT-888 150 mg BID
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01326702-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0001
- arm key
- OG004
- arm label
- Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
- regimen
- Bendamustine 90 mg/m2, ABT-888 200 mg BID
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01326702-om-0001#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0001
- arm key
- OG005
- arm label
- Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
- regimen
- Bendamustine 90 mg/m2, ABT-888 300 mg BID
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01326702-om-0001#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0001
- arm key
- OG006
- arm label
- Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
- regimen
- Bendamustine 90 mg/m2, ABT-888 400 mg BID
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01326702-om-0001#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg
- regimen
- Bendamustine 70 mg/m2, ABT-888 50 mg
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01326702-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
- regimen
- Bendamustine 90 mg/m2, ABT-888 50 mg
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01326702-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
- regimen
- Bendamustine 90 mg/m2, ABT-888 100 mg BID
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01326702-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01326702
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
- regimen
- Bendamustine 90 mg/m2, ABT-888 150 mg BID
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01326702-om-0002#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01326702
- harm key
- EG000
- source section id
- NCT01326702-ae
- event group key
- EG000
- event group label
- Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg
- serious affected
- 1
- serious at risk
- 3
- other affected
- 2
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Source null
- 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-hairy-cell-leukemia
- nct id
- NCT01326702
- harm key
- EG001
- source section id
- NCT01326702-ae
- event group key
- EG001
- event group label
- Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
- serious affected
- 3
- serious at risk
- 3
- other affected
- 1
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Source null
- 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-hairy-cell-leukemia
- nct id
- NCT01326702
- harm key
- EG002
- source section id
- NCT01326702-ae
- event group key
- EG002
- event group label
- Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
- serious affected
- 3
- serious at risk
- 6
- other affected
- 1
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Source null
- 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-hairy-cell-leukemia
- nct id
- NCT01326702
- harm key
- EG003
- source section id
- NCT01326702-ae
- event group key
- EG003
- event group label
- Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
- serious affected
- 2
- serious at risk
- 4
- other affected
- 0
- other at risk
- 4
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Source null
- 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-hairy-cell-leukemia
- nct id
- NCT01326702
- harm key
- EG004
- source section id
- NCT01326702-ae
- event group key
- EG004
- event group label
- Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
- serious affected
- 2
- serious at risk
- 5
- other affected
- 0
- other at risk
- 5
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Source null
- 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-hairy-cell-leukemia
- nct id
- NCT01326702
- harm key
- EG005
- source section id
- NCT01326702-ae
- event group key
- EG005
- event group label
- Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
- serious affected
- 5
- serious at risk
- 15
- other affected
- 0
- other at risk
- 15
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Source null
- 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-hairy-cell-leukemia
- nct id
- NCT01326702
- harm key
- EG006
- source section id
- NCT01326702-ae
- event group key
- EG006
- event group label
- Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
- serious affected
- 3
- serious at risk
- 7
- other affected
- 0
- other at risk
- 7
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Source null
- 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