Trial · NCT07072585
Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)
NCT07072585, Phase 2, Phase 3, Not yet recruiting, Children's Oncology Group
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL). Trials, record NCT07072585. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07072585
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)
- NCT number
- NCT07072585
- Status
- Not yet recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,708 participants, estimated
- Lead sponsor
- Children's Oncology Group
- Conditions
- Stage II T Lymphoblastic Leukemia/Lymphoma, Stage III T Lymphoblastic Leukemia/Lymphoma, Stage IV T Lymphoblastic Leukemia/Lymphoma, T Acute Lymphoblastic Leukemia, T Lymphoblastic Lymphoma
- Interventions
Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Bone Scan, Bortezomib, Calaspargase Pegol, Computed Tomography, Cyclophosphamide, Cytarabine, Daratumumab, Daunorubicin Hydrochloride, Dexamethasone, Doxorubicin Hydrochloride, Echocardiography Test, Lumbar Puncture, Magnetic Resonance Imaging, Mercaptopurine Oral Suspension, Methotrexate, Methylprednisolone, Nelarabine, Pegaspargase, Positron Emission Tomography, Prednisolone, Prednisone, Questionnaire Administration, Radiation Therapy, Therapeutic Hydrocortisone, Thioguanine, Ultrasound Imaging, Vincristine Sulfate
- First posted
- 2025-07-18
- Last updated
- 2026-07-30
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free survival (EFS) in patients with newly diagnosed T-cell lymphoblastic leukemia (T-ALL) | From date of randomization (randomization conducted at the end of induction [EOI]) to date of first event (consolidation failure, interim maintenance failure, relapse, secondary malignant neoplasm [SMN], death from any cause), assessed up to 4 years | Will compare EFS in patients with newly diagnosed T-ALL who are randomized to either receive a modified augmented Berlin-Frankfurt-Munich (aBFM) chemotherapy backbone or a modified aBFM backbone with the addition of daratumumab. Patients without an EFS event will be censored at the date of last follow-up. The survival time analyses assume a Weibull distribution with a shape parameter of 0.45 (based on historical controls). A phase 2/3 design will be used. |
| Primary | EFS in patients with newly diagnosed T-cell lymphoblastic lymphoma (T-LL) | From date of randomization (randomization conducted at the EOI) to date of first event (consolidation failure, relapse, progressive disease, SMN, death from any cause), assessed up to 4 years | Will compare EFS in patients with newly diagnosed T-LL who are randomized to a modified aBFM chemotherapy backbone with bortezomib or to a modified aBFM backbone with bortezomib and the addition of daratumumab. Patients without an EFS event will be censored at the date of last follow-up. The survival time analyses assume a Weibull distribution with a shape parameter of 0.45 (based on historical controls). |
| Secondary | Health-related quality of life (HRQoL) | Baseline (at time of randomization) to day 64 of consolidation | Will compare HRQoL between patients with T-ALL or T-LL randomized to a modified aBFM backbone or to a modified aBFM backbone with the addition of daratumumab. Will use the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health scale (PGH-7). The PROMIS PGH-7 has a standard deviation of 10 points, with higher scores indicating better HRQoL. |
| Secondary | Incidence of therapy-related toxicity and tolerability | Assessed up to 3 cycles post randomization (each cycle is approximately 2-3 months) | Will compare therapy-related toxicity and tolerability between patients with T-ALL or T-LL randomized to a modified aBFM backbone or to a modified aBFM backbone with the addition of daratumumab. Will be assessed for all patients and the rates compared between the randomized arms (T-ALL: arm A versus (vs) arm B and T-LL: arm C vs arm D). Rates by arm will be reviewed by the study committee on a monthly basis and will also be provided in the biannual reports to the Children's Oncology Group Data and Safety Monitoring Committee for review. Any concerns regarding excessive rates of any toxicities will be discussed in the context of any required therapy modifications. |
| Secondary | Overall survival (OS) in patients with newly diagnosed T-ALL | From date of randomization (randomization conducted at the EOI) to date of death (death due to any cause), assessed up to 4 years | Will compare OS in patients with newly diagnosed T-ALL who are randomized to either receive a modified aBFM chemotherapy backbone or a modified aBFM backbone with the addition of daratumumab. Patients who are alive will be censored at date of last follow-up. Comparison of OS between the two randomized arms will be conducted at the time of the final analysis for the primary objective (EFS). Analyses will be based on stratified log-rank tests. In addition, descriptive OS rates post randomization will be estimated using the Kaplan-Meier method and standard errors and confidence intervals estimated by the method of Peto. In particular, 4-year OS rates in arm A and arm B will be estimated. Estimation of treatment effect will be done using intent-to-treat (ITT) analysis. Hazard ratio (HR) and the confidence interval will be estimated based on Cox regression models as appropriate. |
| Secondary | Overall survival (OS) in patients with newly diagnosed T-LL | From date of randomization (randomization conducted at the EOI) to date of death (death due to any cause), assessed up to 4 years | Will compare OS in patients with newly diagnosed T-LL who are randomized to a modified aBFM chemotherapy backbone with bortezomib or to a modified aBFM backbone with bortezomib and the addition of daratumumab. Patients who are alive will be censored at date of last follow-up. Comparison of OS between the two randomized arms will be conducted at the time of the final analysis for the primary objective (EFS). Analyses will be based on log-rank tests. In addition, descriptive OS rates post randomization will be estimated using the Kaplan-Meier method and standard errors and confidence intervals estimated by the method of Peto. In particular, 4-year OS rates in arm C and arm D will be estimated. Estimation of treatment effect will be done using ITT analysis. HR and the confidence interval will be estimated based on Cox regression models as appropriate. |
| Other | EFS from end of induction patients with newly diagnosed T-LL | Assessed up to 4 years | Will determine if minumal residual disease (MRD) testing in patients with newly diagnosed T-LL at EOI can predict EFS. EFS will be compared for T-LL patients with negative MRD (defined as \< 0.1%) and those who with MRD ≥ 0.1% at the EOI. EFS will be defined as time from the EOI to date of first event (consolidation failure, relapse, progressive disease, SMN, death from any cause), and patients without an EFS event will be censored at the date of last follow-up. In addition, comparison of EFS by the EOI MRD status (positive vs negative) will be conducted among randomized patients. Comparisons will be conducted by treatment arms. A potential interaction between MRD at the EOI with treatment arms will be assessed. |
| Other | OS from end of Induction in patients with newly diagnosed T-LL | Assessed up to 4 years | Will determine if MRD testing in patients with newly diagnosed T-LL at EOI can predict OS. OS will be compared for T-LL patients with negative MRD (defined as \< 0.1%) and those who with MRD ≥ 0.1% at the EOI. OS will be defined as time from the EOI to date of death, with patients who are alive being censored at date of last follow-up. In addition, comparison of OS by the EOI MRD status (positive vs negative) will be conducted among randomized patients. Comparisons will be conducted by treatment arms. A potential interaction between MRD at the EOI with treatment arms will be assessed. |
| Other | Immunophenotype in T-ALL patients | Assessed at baseline, end of Induction (Induction is 29 days), and relapse (up to 10 years) | Will describe changes in T-ALL patients in the immunophenotype (specifically CD38 surface expression on T-ALL/T-LL blasts) correlate changes with clinical outcomes and demographic variables. Differences between patients treated with daratumumab and those who are not treated with daratumumab will be assessed; the comparisons between arm A and arm B will be based on test of proportions, Fisher's exact test or logistic regression, as appropriate. |
| Other | Development of anti-daratumumab antibodies in T-ALL patients | Assessed up to 3 years | Will describe the development of anti-daratumumab antibodies over the course of treatment and correlate changes with clinical outcomes and demographic variables. Analyses will be restricted to T-ALL patients randomized to arm B. Analyses will be based on test of proportions, Fisher exact test, logistic regression, log-rank test, semi-parametric or parametric survival analysis, as appropriate. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | 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/NCT07072585
GET https://conductscience.org/api/trials/v1/NCT07072585/registered