Trial · NCT00866749

Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma

NCT00866749, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2019-09-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma. Trials, record NCT00866749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00866749

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Trial

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

Title: Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma
NCT number: NCT00866749
Status: Completed
Phases: Phase 2
Enrollment: 120 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Lymphoblastic Leukemia, Lymphoblastic Lymphoma
Interventions: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Methotrexate, Doxorubicin, Thioguanine
First posted: 2009-03-20
Last updated: 2019-09-10
Results first posted: 2019-09-10

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	3-Year Event-Free Survival (EFS)	3 Years	3-year EFS was calculated based on the participants with a complete response (CR). Study regimen considered successful if it exhibits a 3-year EFS rate greater than 60% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.
Primary	Overall Survival	Up to 12 years	Overall Survival defined: Time from date of treatment start until date of death due to any cause or last Follow-up.
Primary	Participants With a Complete Response (CR)	Up to 1 year	Complete Response defined as: Bone Marrow blasts \</= 5%, Platelets \>/= 100 and an Absolute Neutrophil Count (ANC) \>/= 1000
Secondary	Participants Achieving Negative Minimal Residual Disease (MRD)	up to 3 months	To evaluate the prognostic significance of minimal residual disease (MRD) in bone marrow samples of participants who achieved a complete response (CR) at the end of induction (day 29) and at the end of consolidation (day 84) in this group of patients.

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	3-Year Event-Free Survival (EFS)	3 Years	Of the 108 participants who had a complete response, 68 met the definition for 3 year EFS.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Overall Survival	Up to 12 years		Months	MEDIAN
PRIMARY	Participants With a Complete Response (CR)	Up to 1 year		participants	NUMBER
SECONDARY	Participants Achieving Negative Minimal Residual Disease (MRD)	up to 3 months	Of the 108 participants who achieved a complete response (CR), 60 participants were MRD negative on day 29 and an additional 27 participants were MRD negative on day 84 for a total 87 MRD negative participants on day 84	participants	NUMBER

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Category	Value	Spread	Units
3-Year Event-Free Survival (EFS)	Augmented BFM Therapy		68		Participants
Overall Survival	Augmented BFM Therapy		121	Full Range 0.5 to 140	Months
Participants With a Complete Response (CR)	Augmented BFM Therapy		108		participants
Participants Achieving Negative Minimal Residual Disease (MRD)	Augmented BFM Therapy	Participants with CR and MRD negative on Day 29	60		participants
Participants Achieving Negative Minimal Residual Disease (MRD)	Augmented BFM Therapy	Participants with CR and MRD negative on day 84	87		participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Augmented BFM Therapy	120
Overall Study	COMPLETED	Augmented BFM Therapy	120
Overall Study	NOT COMPLETED	Augmented BFM Therapy	0

Source ClinicalTrials.gov

Adverse events89

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	Colitis	Gastrointestinal disorders	Augmented BFM Therapy	6	120	6
other	Rash	Skin and subcutaneous tissue disorders	Augmented BFM Therapy	6	120	6
other	Supraventricualr arrhythmia	Cardiac disorders	Augmented BFM Therapy	6	120	7
other	Hypoalbuminemia	Metabolism and nutrition disorders	Augmented BFM Therapy	9	120	9
other	Dehydration	Gastrointestinal disorders	Augmented BFM Therapy	9	120	9
other	Lipase	Metabolism and nutrition disorders	Augmented BFM Therapy	9	120	9
other	Mucositis	Gastrointestinal disorders	Augmented BFM Therapy	22	120	26
other	Constipation	Gastrointestinal disorders	Augmented BFM Therapy	11	120	11
other	Pain	General disorders	Augmented BFM Therapy	29	120	38
other	Osteoporosis	Musculoskeletal and connective tissue disorders	Augmented BFM Therapy	11	120	12

1 to 10 of 89Source ClinicalTrials.gov

See all 89 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Augmented BFM Therapy	6	120
Total, other adverse events	Augmented BFM Therapy	111	120
Total, serious adverse events	Augmented BFM Therapy	64	120

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/NCT00866749

GET https://conductscience.org/api/trials/v1/NCT00866749/events?page=2

API reference For AI assistants