Trial · NCT02143414
Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia
NCT02143414, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2023-01-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia. Trials, record NCT02143414. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02143414
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia
- NCT number
- NCT02143414
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Recurrent Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia
- Interventions
Biopsy Procedure, Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration and Biopsy, Computed Tomography, Dasatinib, Echocardiography Test, Lumbar Puncture, Magnetic Resonance Imaging, Mercaptopurine, Methotrexate, Methotrexate Sodium, Prednisone, Vincristine, Vincristine Sulfate, X-Ray Imaging
- First posted
- 2014-05-21
- Last updated
- 2026-08-04
- Results first posted
- 2023-01-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival Rate (Cohort I) | From the day of registration on study until death from any cause, assessed at 3 years | To evaluate the 3-year overall survival rate in elderly participants with newly diagnosed Ph-negative ALL treated with blinatumomab followed by POMP maintenance. Overall |
| Primary | Incidence of Dose-limiting Toxicity (Cohort II) | Up to day 42 of post-remission therapy | Defined as any grade 4 or higher treatment-related, non-hematologic toxicity in the first cycle of post-remission therapy (blinatumomab/dasatinib) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only participants with Ph-positive ALL or Ph-like DSMKF ALL were evaluated. |
| Secondary | Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) | Number of participants with Grade 3-5 adverse events that are possibly, probably or definitely related to study drug are reported by given type of adverse event. Adverse Events reported using CTCAE v 4.0, whereas Serious Adverse Events were reported with CTCAE v 5.0. |
| Secondary | Complete Response Rate (Cohort I) | Participants are assessed after induction treatment and again after re-induction treatment, if re-induction treatment is received (i.e. up to 85 days after registration) | Complete response rate is measured by the number of participants achieving complete remission (CR) or complete remission with incomplete platelet recovery (CRi) rate. CR is defined as having \<5% marrow aspirate blasts, ANC \>1,000/mcL, platelets \> 100,000/mcL, no blasts in peripheral blood, and C1 extramedullary disease status. CRi is the same as CR but platelet count may be \<= 100,000/mcL and/or ANC \<=1,000/mcL. |
| Secondary | Disease-free Survival (Cohort II) | Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) | An estimate of disease free survival in Ph-positive ALL and Ph-like DSMKF ALL (Cohort II). Disease free survival is measured by the number of years between the date the patient first achieves complete remission (CR) or complete remission with incomplete platelet recovery (CRi) until relapse from CR/CRi or death from any cause. CR is defined as having \<5% marrow aspirate blasts, ANC \>1,000/mcL, platelets \> 100,000/mcL, no blasts in peripheral blood, and C1 extramedullary disease status. CRi is the same as CR but platelet count may be \<= 100,000/mcL and/or ANC \<=1,000/mcL. |
| Secondary | Overall Survival (Cohort II) | Up to 10 years | Estimated using the method of Kaplan-Meier. |
| Secondary | Minimal Residual Disease Negativity | Participants are assessed after induction treatment and again after re-induction treatment, if re-induction treatment is received (i.e. up to 85 days after registration) | To estimate in each cohort the rate of minimal residual disease (MRD) negativity. |
| Secondary | Time to Achieve Minimal Residual Disease Negativity | Up to 10 years | Will be examined separately in descriptive analyses within each cohort. |
| Secondary | Anti-idiotype Antibody Development | Up to 10 years | To determine whether anti-idiotype antibodies directed against blinatumomab develop with blinatumomab treatment in this study. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival Rate (Cohort I) | From the day of registration on study until death from any cause, assessed at 3 years | Only participants in Cohort I were evaluated | percentage of participants | NUMBER |
| PRIMARY | Incidence of Dose-limiting Toxicity (Cohort II) | Up to day 42 of post-remission therapy | Only participants in Cohort II that registered to post-remission were analyzed for dose-limiting toxicities. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) | Eligible participants who received at least one dose of protocol treatment. | Participants | NUMBER |
| SECONDARY | Complete Response Rate (Cohort I) | Participants are assessed after induction treatment and again after re-induction treatment, if re-induction treatment is received (i.e. up to 85 days after registration) | Only participants in Cohort I were evaluated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease-free Survival (Cohort II) | Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) | Only participants in Cohort II that achieved complete remission were analyzable. | years | MEDIAN |
| SECONDARY | Overall Survival (Cohort II) | Up to 10 years | |||
| SECONDARY | Minimal Residual Disease Negativity | Participants are assessed after induction treatment and again after re-induction treatment, if re-induction treatment is received (i.e. up to 85 days after registration) | Only participants that had achieved CR or CRi and had available MRD data post-treatment were evaluated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Achieve Minimal Residual Disease Negativity | Up to 10 years | |||
| SECONDARY | Anti-idiotype Antibody Development | Up to 10 years |
Source ClinicalTrials.gov
Results by group381
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival Rate (Cohort I) | Cohort I (Ph-) | 34 | 95% Confidence Interval 18 to 54 | percentage of participants | |
| Incidence of Dose-limiting Toxicity (Cohort II) | Cohort II (Ph+/Ph-like) | 0 | Participants | ||
| Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs | Induction: Cohort I (Ph-) | Abdominal pain | 0 | Participants | |
| Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs | Induction: Cohort II (Ph+/Ph-like) | Abdominal pain | 0 | Participants | |
| Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs | Post-remission: Cohort I (Ph-) | Abdominal pain | 0 | Participants | |
| Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs | Post-remission: Cohort II (Ph+/Ph-like) | Abdominal pain | 0 | Participants | |
| Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs | Maintenance: Cohort I (Ph-) | Abdominal pain | 1 | Participants | |
| Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs | Maintenance: Cohort II (Ph+/Ph-like) | Abdominal pain | 0 | Participants | |
| Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs | Induction: Cohort I (Ph-) | Adult respiratory distress syndrome | 0 | Participants | |
| Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs | Induction: Cohort II (Ph+/Ph-like) | Adult respiratory distress syndrome | 0 | Participants |
1 to 10 of 381Source ClinicalTrials.gov
See all 381 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction | STARTED | Cohort I (Ph-) | 29 | |
| Induction | STARTED | Cohort II (Ph+/Ph-like) | 24 | |
| Induction | Completed Induction | Cohort I (Ph-) | 24 | |
| Induction | Completed Induction | Cohort II (Ph+/Ph-like) | 19 | |
| Induction | COMPLETED | Cohort I (Ph-) | 19 | |
| Induction | COMPLETED | Cohort II (Ph+/Ph-like) | 18 | |
| Induction | NOT COMPLETED | Cohort I (Ph-) | 10 | |
| Induction | NOT COMPLETED | Cohort II (Ph+/Ph-like) | 6 | |
| Post-remission | STARTED | Cohort I (Ph-) | 19 | |
| Post-remission | STARTED | Cohort II (Ph+/Ph-like) | 18 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,788
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 | Induction: Cohort I (Ph-) | 17 | 29 | |
| other | Anemia | Blood and lymphatic system disorders | Induction: Cohort II (Ph+/Ph-like) | 13 | 24 | |
| other | Anemia | Blood and lymphatic system disorders | Post-remission: Cohort I (Ph-) | 9 | 19 | |
| other | Anemia | Blood and lymphatic system disorders | Post-remission: Cohort II (Ph+/Ph-like) | 12 | 18 | |
| other | Anemia | Blood and lymphatic system disorders | Maintenance: Cohort I (Ph-) | 9 | 13 | |
| other | Anemia | Blood and lymphatic system disorders | Maintenance: Cohort II (Ph+/Ph-like) | 9 | 16 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Induction: Cohort I (Ph-) | 1 | 29 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Induction: Cohort II (Ph+/Ph-like) | 1 | 24 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Post-remission: Cohort I (Ph-) | 0 | 19 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Post-remission: Cohort II (Ph+/Ph-like) | 0 | 18 |
1 to 10 of 1,788Source ClinicalTrials.gov
See all 1,788 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction: Cohort I (Ph-) | 1 | 29 |
| Total, all-cause mortality | Induction: Cohort II (Ph+/Ph-like) | 2 | 24 |
| Total, all-cause mortality | Post-remission: Cohort I (Ph-) | 0 | 19 |
| Total, all-cause mortality | Post-remission: Cohort II (Ph+/Ph-like) | 0 | 18 |
| Total, all-cause mortality | Maintenance: Cohort I (Ph-) | 0 | 14 |
| Total, all-cause mortality | Maintenance: Cohort II (Ph+/Ph-like) | 1 | 16 |
| Total, other adverse events | Induction: Cohort I (Ph-) | 28 | 29 |
| Total, other adverse events | Induction: Cohort II (Ph+/Ph-like) | 24 | 24 |
| Total, other adverse events | Post-remission: Cohort I (Ph-) | 19 | 19 |
| Total, other adverse events | Post-remission: Cohort II (Ph+/Ph-like) | 18 | 18 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36322825 | DERIVED |
Source PubMed
Grants1
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 |
|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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/NCT02143414
GET https://conductscience.org/api/trials/v1/NCT02143414/results?page=2