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RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.

ConditionsALL, AdultPhiladelphia-Negative ALL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15-65
SponsorChen Suning

About this trial

In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 15-65

Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria

Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days

ECOG score 0-3

Disqualifiers

Ph+ (BCR-ABL1 positive) ALL

T cells ALL

Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease

Acute mixed-cell leukemia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blinatumomab Injection [Blincyto]

    Drug

    Reduced-intensity chemotherapy followed by Blinatumomab

  • Doxorubicin

    Drug

    HyperCVAD regimen

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Reduced-dose Chemotherapy Followed by BlinatumomabExperimental treatment 1 intervention
Group B: hyperCVADActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite complete remission rate

CR/CRi

Time frame
Induction therapy phase: The time of bone marrow evaluation is day 28±7.

Secondary outcomes

1

The negative rate of minimal residual lesion (MRD)

The negative rate of minimal residual lesion (MRD) during induction therapy (The threshold is 1×10\^-4)

Time frame
Induction therapy phase: The time of bone marrow evaluation is day 28 ±7.
2

Treatment-related AE

Incidence of treatment-related adverse events, including severe bleeding, infection, drug-related adverse events, and organ dysfunction.

Time frame
Induction therapy phase
3

Quality of survival of patients in the induction therapy phase

QLQ-C30 Survival Quality Scale

Time frame
Induction therapy phase
4

Progression-free survival（PFS）

The time from random assignment in a clinical trial to disease progression or death from any cause.

Time frame
1 year after study completion

Other outcomes

Sponsors and contacts

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

Chen Suning

Lead sponsor

The First Affiliated Hospital of Soochow University

Sponsor institution

Source ClinicalTrials.gov
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