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Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT

ConditionLeukemia, Lymphoid
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-65
SponsorSichuan University

About this trial

The goal of this phase I/II clinical trial is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:

• The efficacy and safety of blinatumomab maintenance therapy in reducing the recurrence rate a in R/R ALL patients after allo-HSCT. Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT;

Age ≥16 years old and ≤ 65 years old when signing informed consent Form (ICF);

KPS > 60 or ECOG 0-2;

The expected survival time is more than 3 months;

Disqualifiers

Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;

Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;

Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;

Poor graft function (PGF) occurred after allo-HSCT;

Trial design

Design model

Single group

Treatments tested in this trial

  • blinatumomab

    Drug

    The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.

Treatment groups

68 Participants
are divided into 1 treatment group
Group A: blinatumomabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

Progression free survival of this group of patients at the end of 2 year

Time frame
2 years
2

100 day adverse events (AE)

non-hematologic adverse events

Time frame
Day +100

Secondary outcomes

1

Non-relapse mortality (NRM)

Non-relapse mortality of this group of patients at the end of 6 month

Time frame
6 months
2

Relapse rate

Relapse rate of this group of patients at the end of 2 year

Time frame
2 years
3

Overall survival (OS)

Overall survival of this group of patients at the end of 2 year

Time frame
2 years
4

Cumulative incidence of acute graft versus host disease (aGVHD)

Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100

Time frame
Day +100

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: