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ALL, AdultPhase 2T-ALL-2024NCT06570915

Daratumumab for T Cell ALL With MRD-positive After Standard Chemotherapy

A Phase 2 study testing Daratumumab Injection in people with ALL, Adult, run by Institute of Hematology & Blood Diseases Hospital, China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

T-ALL accounts for about 15%-25% of Ph-negative ALL, and its clinical prognosis is worse than B-ALL. The successful application of immunotherapy has brought revolutionary progress to the treatment of ALL. But progress in the treatment of T-ALL has been relatively slow. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ALL, Adult
What is being tested?
Daratumumab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Dec 2025to 1 Sep 2028
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with newly diagnosed T-cell acute lymphoblastic leukemia confirmed by cell morphology and immunophenotype had flow MRD≥0.01% 3 months after chemotherapy; or patients with T-cell acute lymphoblastic leukemia relapsed achieved CR again after salvage chemotherapy, but the flow MRD was ≥0.01%
  • Age ≥18 years old, male or female
  • The expression of CD38 in tumor cells was positive
  • Men and women who may give birth agree to and use effective contraceptive methods
  • Main organ function assessment criteria: total bilirubin < 1.5× upper normal limit (ULN), glutamic oxalic aminotransferase (AST) and glutamic alanine aminotransferase (ALT) ≤2.5×ULN; Serum creatinine < 2×ULN; Myocardial enzyme < 2×ULN; Serum amylase ≤1.5×ULN; Left ventricular ejection fraction (LEF) was > 45%
  • Understand and sign the informed consent and agree to comply with the study requirements

Who cannot join

  • SAEs related to the study emerged during the study, and the investigator judged that the necessity of quitting the project was greater than the benefit
  • In case of any situation in which the subjects could not tolerate the study regimen, the investigator assessed that the necessity of withdrawal from the regimen outweighed the benefit
  • The subject had an allergic reaction to any drug of the study regimen or other conditions that prevented the regimen from continuing
  • Subjects voluntarily asked to withdraw from the study at any time
  • Any situation in which the investigator determines that the benefit of withdrawing from the study outweighs the benefit

About this study

Official title: A Prospective, Single-arm, Multicenter, Open-label , Phase 2 Study to Evaluate Efficacy and Safety of the Daratumumab in T Cell Acute Lymphoblastic Leukemia With Minimal Residual-Positive After Standard Chemotherapy

T-ALL accounts for about 15%-25% of Ph-negative ALL, and its clinical prognosis is worse than B-ALL. The successful application of immunotherapy has brought revolutionary progress to the treatment of ALL. But progress in the treatment of T-ALL has been relatively slow. Minimal residual disease (MRD) is a strong prognostic indicator for ALL patients. MRD-positive after induction therapy predicts a high risk of relapse. The National Comprehensive Cancer Network (NCCN) considers MRD-positive ALL patients to be at high risk. Research in the B-ALL field has demonstrated that immunotherapy has the potential to further clear MRD, which in turn translates into survival benefits. Daratumumab is a humanized, anti-CD38 IgG1 monoclonal antibody that binds to CD38 expressed by tumor cells. Apoptosis of tumor cells is induced through a variety of immune-related mechanisms such as complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cytophagocytosis (ADCP), and FCγ receptors, which are currently mainly used in the treatment of multiple myeloma. CD38 is highly and stably expressed on the surface of T-ALL cells, and its expression was less influenced by the previous treatment. Preliminary data from the clinical study of daratumumab combined with BFM bone frame prescription for the treatment of recurrent refractory T ALL(NCT03384654) showed that the effectiveness rate (ORR) was 83.3% in children and 60% in young adults. Compared with the previous historical data, the safety and tolerability were significantly improved. For T-ALL patients who relapse after allogeneic transplantation and achieve CR with intense chemotherapy but continue to have MRD-positive flow rate, daratumumab monotherapy can further clear MRD and achieve the purpose of sustaining CR. These studies all demonstrate the potential role of daratumumab in the treatment of T-ALL. Based on the current difficulties in the treatment of T-ALL and existing research data, we plan to conduct a prospective, single-arm, open-label phase II clinical study to explore the efficacy and safety of daratumumab for flow minimal residual disease positive T-ALL after standard chemotherapy.

Read the detailed description

Daratumumab is administered once a week at a dose of 16 mg/kg for a total of 4 times (Day1,8,15,22) in one cycle. Conditions patients can use up to two cycles of treatment.

Conditions
ALL, Adult
Being tested
Daratumumab Injection
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daratumumab InjectionDrug

    Daratumumab was administered once a week at a dose of 16 mg/kg for a total of 4 times (Day1,8,15,22 ) in one cycle.

Study groups in NCT06570915
Study groupRoleWhat they receive
DaratumumabExperimentalDaratumumab was administered once a week at a dose of 16 mg/kg for a total of 4 times (Day1,8,15,22 dosing patterns) in one cycle. Patients with conditions may use up to two cycles of treatment.
Receives: Drug: Daratumumab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of conversion from MRD+to MRD- by flow cytometry after 1 cycle of daretuzumab treatment

    If no abnormal phenotypic leukemia cells were detected by flow cytometry, flow MRD-negative was considered

    Measured: up to 28days ±3days after daretuzumab treatment

Secondary outcomes (7)

  1. overall survival overall survival overall survival

    The interval from the date of enrollment to the date of death or the date of last follow-up, whichever occurred first.

    Measured: up to 2 years after the date of the last enrolled participants

  2. Disease-free survival (DFS)

    Only for CR patients who chieved CR. The interval from the date of CR1 to relapse, death from any cause or last follow-up.

    Measured: up to 2 years after the date of the last enrolled participants

  3. Cumulative incidence of relapse (CIR)

    Calculated with the cumulative incidence method, with death in patients who had a complete hematologic response as a competing risk.

    Measured: up to 2 years after the date of the last enrolled participants

  4. duration of MRD-negative response

    No blasts were detected by flow cytometry after daretuzumab treatment

    Measured: up to 2 years after the date of the last enrolled participants

  5. Rate of conversion from MRD+to MRD- by NGS

    Next-generation sequencing (NGS) is a high-throughput sequencing methodology and is a process by which small fragments of DNA are sequenced in parallel multiple times

    Measured: up to 2 years after the date of the last enrolled participants

  6. 30-day mortality

    Percentage of patients who died within 30 days from enrollment

    Measured: Within 30 days of the date of the last enrolled participants

  7. 60-day mortality

    Percentage of patients who died within 60 days from enrollment

    Measured: Within 60 days of the date of the last enrolled participants

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Why it stopped: No eligeble patients

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06570915
Sponsor's protocol ID
IIT2024056
Acronym
T-ALL-2024
Status last verified
May 2026
First submitted
22 Aug 2024
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab Injection in people with ALL, Adult, run by Institute of Hematology & Blood Diseases Hospital, China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of conversion from MRD+to MRD- by flow cytometry after 1 cycle of daretuzumab treatment (time frame: up to 28days ±3days after daretuzumab treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06570915.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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