Trial · NCT03207555
Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)
NCT03207555, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2025-09-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL). Trials, record NCT03207555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03207555
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)
- NCT number
- NCT03207555
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic, Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
- Interventions
- Ibrutinib
- First posted
- 2017-07-02
- Last updated
- 2025-09-02
- Results first posted
- 2025-09-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With Complete Remission (CR) at 24 Months | Up to 24 months | Complete Remission (CR): Peripheral blood lymphocytes below 4 x 10\^9/L (4000/ƒÝL), Absence of significant lymphadenopathy (lymph nodes \>1.5 cm in diameter) by CT(or PET) examination of neck, thorax, abdomen and pelvis, No hepatomegaly or splenomegaly by physical examination (and CT/PET if assessment was abnormal before therapy or if physical exam is inconclusive), Absence of constitutional symptoms, Neutrophils more than 1.5 x 10\^9/L (1500/ƒÝL) without need for exogenous growth factors, Platelets more than 100 x 10\^9/L (100 000/ƒÝL) without need for exogenous growth factors, Hemoglobin more than 110 g/L (11.0 g/dL) without red blood cell transfusion or need for exogenous erythropoietin, Bone Marrow aspirate and biopsy, demonstrating at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent. If the bone marrow is hypocellular, a repeat determination should be made in 4 weeks or when peripheral blood counts have recovered. |
| Primary | Participants With Partial Remission (PR) at 24 Months | Up to 24 months | Partial Remission (PR) at least one of criteria 1-3, and one or more of the features listed in number 4. 1. A decrease lymphocytes by 50% or more from the value before therapy. 2. Reduction in lymphadenopathy, defined by the following: - A decrease in lymph node size by 50% or more either in the sum products of up to 6 lymph nodes, or in the largest diameter of the enlarged lymph node(s) detected prior to therapy. - No increase in lymph node, and no new enlarged lymph node. In small lymph nodes (\</=2 cm), an increase of less than 25% is not considered to be significant. 3. A reduction in enlargement of the spleen or liver by 50% or more. 4. The blood count should show one or more of the following results: - Neutrophils more than 1, without need for exogenous growth factors. - Platelet counts greater than 100 x10\^9/L (100 000/ƒÝL) or 50% improvement over baseline without need for exogenous growth factors. - Hemoglobin greater than 11 |
| Secondary | Progression-Free Survival (PFS) at 24 Months | 24 months | Time from date of treatment start until the date of progression or death from leukemia. |
| Secondary | Overall Response at 24 Months | Up to 24 months | Overall Response is participants who achieve Complete Remission (CR) or Partial Remission (PR) at 24 months of treatment. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Complete Remission (CR) at 24 Months | Up to 24 months | Of the 23 participants registered on-study, 18 participants were evaluable. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Participants With Partial Remission (PR) at 24 Months | Up to 24 months | Of the 23 participants registered on-study, 18 participants were evaluable. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival (PFS) at 24 Months | 24 months | Of the 23 participants registered on-study, 18 participants were evaluable. | Months | MEDIAN |
| SECONDARY | Overall Response at 24 Months | Up to 24 months | Of the 23 participants registered on-study, 18 participants were evaluable. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Complete Remission (CR) at 24 Months | Ibrutinib | 3 | Participants | ||
| Participants With Partial Remission (PR) at 24 Months | Ibrutinib | 15 | Participants | ||
| Progression-Free Survival (PFS) at 24 Months | Ibrutinib | NA | Full Range NA to NA | Months | |
| Overall Response at 24 Months | Ibrutinib | 18 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibrutinib | 23 | |
| Overall Study | COMPLETED | Ibrutinib | 23 | |
| Overall Study | NOT COMPLETED | Ibrutinib | 0 |
Source ClinicalTrials.gov
Adverse events56
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 | Abdominal pain | Gastrointestinal disorders | Ibrutinib | 2 | 23 | 2 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Ibrutinib | 8 | 23 | 10 |
| other | Anemia | Blood and lymphatic system disorders | Ibrutinib | 3 | 23 | 3 |
| other | Anxiety | Psychiatric disorders | Ibrutinib | 2 | 23 | 2 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ibrutinib | 11 | 23 | 16 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Ibrutinib | 4 | 23 | 5 |
| other | Bruising | Injury, poisoning and procedural complications | Ibrutinib | 13 | 23 | 16 |
| other | Chills | General disorders | Ibrutinib | 2 | 23 | 2 |
| other | Constipation | Gastrointestinal disorders | Ibrutinib | 5 | 23 | 5 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Ibrutinib | 6 | 23 | 6 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibrutinib | 0 | 23 |
| Total, other adverse events | Ibrutinib | 23 | 23 |
| Total, serious adverse events | Ibrutinib | 6 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03207555
GET https://conductscience.org/api/trials/v1/NCT03207555/events?page=2