Who is sponsoring NCT06253637?

NCT06253637 is sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto.

What drugs are being tested in NCT06253637?

Interventions in NCT06253637: Daratumumab plus chemotherapy according to the national treatment program.

What condition does NCT06253637 study?

NCT06253637 studies T-Lymphocytic Leukemia, Acute.

Is NCT06253637 still recruiting?

NCT06253637 is currently active, enrolled. Last updated 4 March 2026.

Last reviewed 2026-03-04 · How we verify

NCT06253637: DARATALL-VHR

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Daratumumab in Very High-Risk T-Lineage Acute Lymphoblastic Leukemia (ALL) Treated According to the ALL National Treatment Program (DARATALL-VHR)

Active, enrolled Phase 2 Last updated 4 March 2026

What this trial tests

Phase 2 trial testing Daratumumab plus chemotherapy according to the national treatment program in T-Lymphocytic Leukemia, Acute in 31 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 October 2024

Primary endpoint
1 October 2029

1 October 2029

Quick facts

Lead sponsor	Gruppo Italiano Malattie EMatologiche dell'Adulto
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	17 October 2024
Primary completion	1 October 2029
Estimated completion	1 October 2029
Sites	3 locations across Italy

Drugs / interventions tested

Daratumumab plus chemotherapy according to the national treatment program — full drug profile →

Conditions studied

T-Lymphocytic Leukemia, Acute — all drugs for T-Lymphocytic Leukemia, Acute →

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto — full company profile →

Who can join

Adults 18 to 65, any sex, with T-Lymphocytic Leukemia, Acute. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

MRD-negativity rate after cycle 1
Time frame: 1 month
Number of patients on the total of evaluable patients without residual disease after the first induction cycle with chemotherapy plus daratumumab

Sponsor's own description

The goal of this clinical trial is to test daratumumab in adult very high risk T-lineage lymphoblastic leukemia. The main question it aims to answer is wether the addition of daratumumab daratumumab to the national standard of care is able to increase the rate of MRD-negative patients after induction therapy. Participants will be treated with: • daratumumab in combination with a pediatric-inspired treatment scheme - as in the previous GIMEMA LAL1913 protocol.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

One step further in targeting acute leukemia by combining antibody-based immunotherapies and small molecule inhibitors.
Dozandeh-Jouybari A, Rohaninia E, Faaliat S, Joudaki N, et al · · 2025 · cited 1× · PMID 40624659 · DOI 10.1186/s12935-025-03869-w

Verify or expand the search:

Other Gruppo Italiano Malattie EMatologiche dell'Adulto trials

Trials by the same sponsor.

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NCT06657846 — HRQoL and Financial Toxicity in Patients With VEXAS Syndrome · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06253637 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gruppo Italiano Malattie EMatologiche dell'Adulto
Last refreshed: 4 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06253637.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing