Trial · NCT01515176
Ofatumumab and Dinaciclib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia
NCT01515176, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2018-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ofatumumab and Dinaciclib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia. Trials, record NCT01515176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01515176
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ofatumumab and Dinaciclib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia
- NCT number
- NCT01515176
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia
- Interventions
- Dinaciclib, Laboratory Biomarker Analysis, Ofatumumab, Pharmacological Study
- First posted
- 2012-01-23
- Last updated
- 2018-03-15
- Results first posted
- 2018-03-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum-tolerated Dose of Dinaciclib When Given in Combination With Ofatumumab, Defined as a Dose Level Where at Most One of 6 Evaluable Patients Has a Dose Limiting Toxicity (Phase Ia) | Day 56 | Graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0. Assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization. |
| Primary | Number of Patients With Dose-limiting Toxicity Incidents Graded According to the NCI CTCAE v4.0 (Phase I) | Up to day 56 | Hematologic dose-limiting toxicity measures will be assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via CTCAE version 4 standard toxicity grading. Non-hematologic dose-limiting toxicities such as dyspnea and renal will be evaluated via the ordinal CTCAE standard toxicity grading only. |
| Primary | Percentage of Patients Who Achieve an Overall Response, Defined as Achieving a Complete Response, an Unconfirmed Complete Response (SLL Only), or a Partial Response (Phase II) | Up to 28 weeks | 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. |
| Secondary | Complete Response Rate | Up to 28 weeks | 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 |
| Secondary | Overall Survival | Time from study entry to death due to any cause, assessed up to 5 years | Distributions will be explored and assessed using the methods of Kaplan and Meier. |
| Secondary | Progression Free Survival | Time from study entry to documentation of disease progression and/or death, assessed up to 5 years | 95% confidence intervals will be constructed using the methods of Duffy and Santner with the assumption that these rates are binomially distributed. Distributions will be explored and assessed using the methods of Kaplan and Meier. |
| Secondary | Time to Treatment Failure | Time from study entry to the date patients end treatment, up to 28 weeks | Distributions will be explored and assessed using the methods of Kaplan and Meier. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum-tolerated Dose of Dinaciclib When Given in Combination With Ofatumumab, Defined as a Dose Level Where at Most One of 6 Evaluable Patients Has a Dose Limiting Toxicity (Phase Ia) | Day 56 | mg/m2 | NUMBER | |
| PRIMARY | Number of Patients With Dose-limiting Toxicity Incidents Graded According to the NCI CTCAE v4.0 (Phase I) | Up to day 56 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Percentage of Patients Who Achieve an Overall Response, Defined as Achieving a Complete Response, an Unconfirmed Complete Response (SLL Only), or a Partial Response (Phase II) | Up to 28 weeks | percentage of patients | NUMBER | |
| SECONDARY | Complete Response Rate | Up to 28 weeks | patients with complete response | NUMBER | |
| SECONDARY | Overall Survival | Time from study entry to death due to any cause, assessed up to 5 years | days | MEDIAN | |
| SECONDARY | Progression Free Survival | Time from study entry to documentation of disease progression and/or death, assessed up to 5 years | days | MEDIAN | |
| SECONDARY | Time to Treatment Failure | Time from study entry to the date patients end treatment, up to 28 weeks | days | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum-tolerated Dose of Dinaciclib When Given in Combination With Ofatumumab, Defined as a Dose Level Where at Most One of 6 Evaluable Patients Has a Dose Limiting Toxicity (Phase Ia) | Treatment (Ofatumumab, Dinaciclib) | 2 hr infusion cycle 2 day 2 | 7 | mg/m2 | |
| Maximum-tolerated Dose of Dinaciclib When Given in Combination With Ofatumumab, Defined as a Dose Level Where at Most One of 6 Evaluable Patients Has a Dose Limiting Toxicity (Phase Ia) | Treatment (Ofatumumab, Dinaciclib) | 2 hr infusion cycle 2 day 8 | 10 | mg/m2 | |
| Maximum-tolerated Dose of Dinaciclib When Given in Combination With Ofatumumab, Defined as a Dose Level Where at Most One of 6 Evaluable Patients Has a Dose Limiting Toxicity (Phase Ia) | Treatment (Ofatumumab, Dinaciclib) | cycle 2 day 8 | 14 | mg/m2 | |
| Number of Patients With Dose-limiting Toxicity Incidents Graded According to the NCI CTCAE v4.0 (Phase I) | Dose Level I: Treatment (Ofatumumab, Dinaciclib) | 0 | Participants | ||
| Number of Patients With Dose-limiting Toxicity Incidents Graded According to the NCI CTCAE v4.0 (Phase I) | Dose Level II: Treatment (Ofatumumab, Dinaciclib) | 0 | Participants | ||
| Percentage of Patients Who Achieve an Overall Response, Defined as Achieving a Complete Response, an Unconfirmed Complete Response (SLL Only), or a Partial Response (Phase II) | Dose Level I and Dose Level II | 39 | 95% Confidence Interval 23 to 57 | percentage of patients | |
| Complete Response Rate | Treatment (Ofatumumab, Dinaciclib) | 0 | 95% Confidence Interval 0 to 0 | patients with complete response | |
| Overall Survival | Treatment (Ofatumumab, Dinaciclib) | 990 | 95% Confidence Interval 678 to NA | days | |
| Progression Free Survival | Dose Level I and Dose Level II | 322 | 95% Confidence Interval 223 to 402 | days | |
| Time to Treatment Failure | Treatment (Ofatumumab, Dinaciclib) | 248 | 95% Confidence Interval 113 to 347 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level I: Treatment (Ofatumumab, Dinaciclib) | 4 | |
| Overall Study | STARTED | Dose Level II: Treatment (Ofatumumab, Dinaciclib) | 32 | |
| Overall Study | COMPLETED | Dose Level I: Treatment (Ofatumumab, Dinaciclib) | 4 | |
| Overall Study | COMPLETED | Dose Level II: Treatment (Ofatumumab, Dinaciclib) | 32 | |
| Overall Study | NOT COMPLETED | Dose Level I: Treatment (Ofatumumab, Dinaciclib) | 0 | |
| Overall Study | NOT COMPLETED | Dose Level II: Treatment (Ofatumumab, Dinaciclib) | 0 |
Source ClinicalTrials.gov
Adverse events218
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Dose Level I: Treatment (Ofatumumab, Dinaciclib) | 3 | 4 | 7 |
| other | Anemia | Blood and lymphatic system disorders | Dose Level II: Treatment (Ofatumumab, Dinaciclib) | 28 | 32 | 54 |
| other | Lymphode Pain | Blood and lymphatic system disorders | Dose Level I: Treatment (Ofatumumab, Dinaciclib) | 0 | 4 | 0 |
| other | Lymphode Pain | Blood and lymphatic system disorders | Dose Level II: Treatment (Ofatumumab, Dinaciclib) | 6 | 32 | 8 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level I: Treatment (Ofatumumab, Dinaciclib) | 1 | 4 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level II: Treatment (Ofatumumab, Dinaciclib) | 2 | 32 | 2 |
| other | Bloating | Gastrointestinal disorders | Dose Level I: Treatment (Ofatumumab, Dinaciclib) | 0 | 4 | 0 |
| other | Bloating | Gastrointestinal disorders | Dose Level II: Treatment (Ofatumumab, Dinaciclib) | 3 | 32 | 5 |
| other | Constipation | Gastrointestinal disorders | Dose Level I: Treatment (Ofatumumab, Dinaciclib) | 1 | 4 | 2 |
| other | Constipation | Gastrointestinal disorders | Dose Level II: Treatment (Ofatumumab, Dinaciclib) | 11 | 32 | 15 |
1 to 10 of 218Source ClinicalTrials.gov
See all 218 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level I: Treatment (Ofatumumab, Dinaciclib) | 0 | 4 |
| Total, all-cause mortality | Dose Level II: Treatment (Ofatumumab, Dinaciclib) | 1 | 32 |
| Total, other adverse events | Dose Level I: Treatment (Ofatumumab, Dinaciclib) | 4 | 4 |
| Total, other adverse events | Dose Level II: Treatment (Ofatumumab, Dinaciclib) | 32 | 32 |
| Total, serious adverse events | Dose Level I: Treatment (Ofatumumab, Dinaciclib) | 3 | 4 |
| Total, serious adverse events | Dose Level II: Treatment (Ofatumumab, Dinaciclib) | 32 | 32 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants4
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA016058 | Cancer Center Support Grant | RATHMELL, WENDY KIMRYN | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| UM1CA186712 | The Ohio State University as a Lead Academic Organization (LAO) for the Experimental Therapeutics Clinical Trials Network | CARSON, WILLIAM E.; ARNOLD, SUSANNE M; EPPERLA, NARENDRANATH | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| P50CA140158 | Experimental Therapeutics of Leukemia | BYRD, JOHN C. | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2009 to 2013 | NIH RePORTER |
| U01CA076576 | Phase I Trials of Anti-Cancer Agents | GREVER, MICHAEL R | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1998 to 2013 | NIH RePORTER |
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Dose Level I: Treatment (Ofatumumab, Dinaciclib) vs Dose Level II: Treatment (Ofatumumab, Dinaciclib): Number of Patients With Dose-limiting Toxicity Incidents Graded According to the NCI CTCAE v4.0 (Phase I) | Trial comparisons |
| Dose Level I: Treatment (Ofatumumab, Dinaciclib) vs Dose Level II: Treatment (Ofatumumab, Dinaciclib): deaths from any cause | Trial comparisons |
| Dose Level I: Treatment (Ofatumumab, Dinaciclib) vs Dose Level II: Treatment (Ofatumumab, Dinaciclib): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01515176
GET https://conductscience.org/api/trials/v1/NCT01515176/events?page=2