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Trial · NCT01029366

CART19 to Treat B-Cell Leukemia or Lymphoma That Are Resistant or Refractory to Chemotherapy

NCT01029366, Phase 1, Completed, University of Pennsylvania; results first posted 2017-02-28

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. CART19 to Treat B-Cell Leukemia or Lymphoma That Are Resistant or Refractory to Chemotherapy. Trials, record NCT01029366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01029366

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
CART19 to Treat B-Cell Leukemia or Lymphoma That Are Resistant or Refractory to Chemotherapy
NCT number
NCT01029366
Status
Completed
Phases
Phase 1
Enrollment
26 participants, actual
Lead sponsor
University of Pennsylvania
Conditions
Hematopoietic/Lymphoid Cancer, Adult Acute Lymphoblastic Leukemia in Remission, B-cell Adult Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Refractory Chronic Lymphocytic Leukemia, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Chronic Lymphocytic Leukemia, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Chronic Lymphocytic Leukemia, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma
Interventions
CART-19
First posted
2009-12-10
Last updated
2023-06-22
Results first posted
2017-02-28

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants With Adverse Events5 years
SecondaryOverall Response Summary5 years
Efficacy assessments for ALL were performed based on bone marrow and blood morphologic criteria and physical examination findings. The definitions for response are primarily based on the standardized response criteria defined by National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2013 v.1). Efficacy assessments for CLL were based on lymphadenopathy, hepatomegaly, splenomegaly, bone marrow and blood morphologic and laboratory assessments. The response criteria are consistent with NCCN Guidelines Version 2.2012 CLL/SLL, which is based on the 2008 International Workshop Group on CLL (IWCLL) revisions of the original guidelines for evaluating disease response released in 1996 by the National Cancer Institute Working Group (NCI/WG).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Adverse Events5 yearsparticipantsNUMBER
SECONDARYOverall Response Summary5 yearspercentage of participantsNUMBER

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Participants With Adverse EventsAll Participants20participants
Overall Response SummaryCLL SubjectsComplete Remission21.4percentage of participants
Overall Response SummaryALL SubjectsComplete Remission83.4percentage of participants
Overall Response SummaryCLL SubjectsPartial Remission21.4percentage of participants
Overall Response SummaryALL SubjectsPartial Remission0percentage of participants
Overall Response SummaryCLL SubjectsNo Remission57.1percentage of participants
Overall Response SummaryALL SubjectsNo Remission16.7percentage of participants
Overall Response SummaryCLL SubjectsOverall Response Rate42.9percentage of participants
Overall Response SummaryALL SubjectsOverall Response Rate83.3percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDChronic Lymphocytic Leukemia (CLL) Subjects18
Overall StudySTARTEDAcute Lymphocytic Leukemia (ALL) Subjects8
Overall StudyCOMPLETEDChronic Lymphocytic Leukemia (CLL) Subjects14
Overall StudyCOMPLETEDAcute Lymphocytic Leukemia (ALL) Subjects6
Overall StudyNOT COMPLETEDChronic Lymphocytic Leukemia (CLL) Subjects4
Overall StudyNOT COMPLETEDAcute Lymphocytic Leukemia (ALL) Subjects2

Source ClinicalTrials.gov

Adverse events152

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherFatigueGeneral disordersChronic Lymphocytic Leukemia131413
otherFatigueGeneral disordersAcute Lymphocytic Leukemia262
otherPyrexiaGeneral disordersChronic Lymphocytic Leukemia111411
otherPyrexiaGeneral disordersAcute Lymphocytic Leukemia262
otherBlood Albumin decreasedInvestigationsChronic Lymphocytic Leukemia8148
otherBlood Albumin decreasedInvestigationsAcute Lymphocytic Leukemia161
otherChillsGeneral disordersChronic Lymphocytic Leukemia8148
otherChillsGeneral disordersAcute Lymphocytic Leukemia060
otherCytokine Release SyndromeImmune system disordersChronic Lymphocytic Leukemia8148
otherCytokine Release SyndromeImmune system disordersAcute Lymphocytic Leukemia666

1 to 10 of 152Source ClinicalTrials.gov

See all 152 adverse events

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityChronic Lymphocytic Leukemia
Total, all-cause mortalityAcute Lymphocytic Leukemia
Total, other adverse eventsChronic Lymphocytic Leukemia1414
Total, other adverse eventsAcute Lymphocytic Leukemia66
Total, serious adverse eventsChronic Lymphocytic Leukemia1414
Total, serious adverse eventsAcute Lymphocytic Leukemia66

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
25317870DERIVEDPubMed
31076448DERIVEDPubMed
31815579DERIVEDPubMed

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Chronic Lymphocytic Leukemia vs Acute Lymphocytic Leukemia: serious adverse events

Source 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT01029366

GET https://conductscience.org/api/trials/v1/NCT01029366/events?page=2

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