Trial · NCT01700946

Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma

NCT01700946, Phase 2, Completed, St. Jude Children's Research Hospital; results first posted 2022-09-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma. Trials, record NCT01700946. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01700946

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Trial

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

Title: Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma
NCT number: NCT01700946
Status: Completed
Phases: Phase 2
Enrollment: 80 participants, actual
Lead sponsor: St. Jude Children's Research Hospital
Conditions: Recurrent B-Cell Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood B-Lymphoblastic Lymphoma
Interventions: dexamethasone, vincristine sulfate, rituximab, clofarabine, cyclophosphamide, etoposide, aldesleukin, pegaspargase, methotrexate, mercaptopurine, cytarabine, mitoxantrone, teniposide, vinblastine, natural killer cell infusion, laboratory biomarker analysis, therapeutic hydrocortisone, allogeneic hematopoietic stem cell transplantation, CliniMACS
First posted: 2012-10-04
Last updated: 2022-09-28
Results first posted: 2022-09-28

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	3-year Overall Survival Rate of Patients With Relapsed ALL	3 years of follow-up since the on-study date	Estimate the 3-year survival rate of participants with first relapse or primary refractory precursor B-cell ALL treated with risk-directed therapy.
Primary	3-year Event-free Survival Rates in Patients With Relapsed ALL	3 years of follow-up since the on-study date	Estimate the 3-year event-free survival rate of participants with first relapse or primary refractory precursor B-cell ALL treated with risk-directed therapy.
Secondary	Proportion of Participants With Positive Minimal Residual Disease	At end of induction (approximately 3 months)	To determine minimal residual disease (MRD) levels at the end of remission induction therapy for participants with relapsed precursor B-cell ALL and compare the results with those in protocol ALLR17 (NCT00186875).
Secondary	Mean of CD20 Expression Levels	Baseline and at the end of Block I (approximately 5 weeks after the on-study date)	To estimate mean levels of CD20 expression at baseline, during treatment with dexamethasone-containing chemotherapy and following rituximab treatment in Block I of remission induction therapy for relapsed precursor B-cell ALL.
Secondary	Median CD20 Expression Levels	Baseline and at the end of Block I (approximately 5 weeks after the on-study date)	To estimate median levels of CD20 expression at baseline, during treatment with dexamethasone-containing chemotherapy and following rituximab treatment in Block I of remission induction therapy for relapsed precursor B-cell ALL.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	3-year Overall Survival Rate of Patients With Relapsed ALL	3 years of follow-up since the on-study date		percentage of participants	NUMBER
PRIMARY	3-year Event-free Survival Rates in Patients With Relapsed ALL	3 years of follow-up since the on-study date		percentage of participants	NUMBER
SECONDARY	Proportion of Participants With Positive Minimal Residual Disease	At end of induction (approximately 3 months)	On ALLR18, a total of 42 patients enrolled. Of them, 24 patients had MRD data at the end of Remission Induction. On ALLR17, a total of 40 patients enrolled. Of them, 32 patients had MRD data at the end of Remission Induction	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean of CD20 Expression Levels	Baseline and at the end of Block I (approximately 5 weeks after the on-study date)	Of the 42 patients enrolled, 34 patients had At Baseline data; 42 patients had data At Block I	percentage of CD20 Antigen	MEAN
SECONDARY	Median CD20 Expression Levels	Baseline and at the end of Block I (approximately 5 weeks after the on-study date)	Of the 42 patients enrolled, 34 patients had At Baseline data; 42 patients had data At Block I	percentage of CD20 Antigen	MEDIAN

Source ClinicalTrials.gov

Results by group26

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

Outcome	Group	Category	Value	Spread	Units
3-year Overall Survival Rate of Patients With Relapsed ALL	STANDARD RISK		94.4	95% Confidence Interval 66.6 to 99.2	percentage of participants
3-year Overall Survival Rate of Patients With Relapsed ALL	HIGH RISK		55.5	95% Confidence Interval 33.0 to 73.2	percentage of participants
3-year Overall Survival Rate of Patients With Relapsed ALL	All Patients Enrolled on the Study		72.63	95% Confidence Interval 55.95 to 83.85	percentage of participants
3-year Event-free Survival Rates in Patients With Relapsed ALL	STANDARD RISK		83.3	95% Confidence Interval 56.8 to 94.3	percentage of participants
3-year Event-free Survival Rates in Patients With Relapsed ALL	HIGH RISK		55.7	95% Confidence Interval 33.2 to 73.4	percentage of participants
3-year Event-free Survival Rates in Patients With Relapsed ALL	All Patients Enrolled on the Study		67.83	95% Confidence Interval 51.04 to 79.9	percentage of participants
Proportion of Participants With Positive Minimal Residual Disease	STANDARD RISK	MRD end-induction: Negative	14		Participants
Proportion of Participants With Positive Minimal Residual Disease	HIGH RISK	MRD end-induction: Negative	6		Participants
Proportion of Participants With Positive Minimal Residual Disease	ALLR18	MRD end-induction: Negative	20		Participants
Proportion of Participants With Positive Minimal Residual Disease	ALLR17	MRD end-induction: Negative	22		Participants

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	STANDARD RISK	18
Overall Study	STARTED	HIGH RISK	24
Overall Study	COMPLETED	STANDARD RISK	7
Overall Study	COMPLETED	HIGH RISK	7
Overall Study	NOT COMPLETED	STANDARD RISK	11
Overall Study	NOT COMPLETED	HIGH RISK	17

Source ClinicalTrials.gov

Adverse events405

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
other	Hyperglycemia	Metabolism and nutrition disorders	STANDARD RISK	18	18
other	Hyperglycemia	Metabolism and nutrition disorders	HIGH RISK	22	24
other	Hyperglycemia	Metabolism and nutrition disorders	All Patients Enrolled on the Study	40	42
other	Hypoalbuminemia	Metabolism and nutrition disorders	STANDARD RISK	17	18
other	Hypoalbuminemia	Metabolism and nutrition disorders	HIGH RISK	23	24
other	Hypoalbuminemia	Metabolism and nutrition disorders	All Patients Enrolled on the Study	40	42
other	Alanine aminotransferase increased	Investigations	STANDARD RISK	18	18
other	Alanine aminotransferase increased	Investigations	HIGH RISK	21	24
other	Alanine aminotransferase increased	Investigations	All Patients Enrolled on the Study	39	42
other	Aspartate aminotransferase increased	Investigations	STANDARD RISK	17	18

1 to 10 of 405Source ClinicalTrials.gov

See all 405 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	STANDARD RISK	3	18
Total, all-cause mortality	HIGH RISK	10	24
Total, all-cause mortality	All Patients Enrolled on the Study	13	42
Total, other adverse events	STANDARD RISK	18	18
Total, other adverse events	HIGH RISK	23	24
Total, other adverse events	All Patients Enrolled on the Study	41	42
Total, serious adverse events	STANDARD RISK	1	18
Total, serious adverse events	HIGH RISK	0	24
Total, serious adverse events	All Patients Enrolled on the Study	1	42

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.

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/NCT01700946

GET https://conductscience.org/api/trials/v1/NCT01700946/results?page=2

API reference For AI assistants