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

NCT06250959 | Recruiting Phase 2 FDA Drug

• 1 other identifier: BEAT-ALL-2024
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ALL, Adult; Philadelphia-Negative ALL

Outcome Measures

Primary Outcomes (1)

• Composite complete remission rate

  CR/CRi

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

Secondary Outcomes (5)

• The negative rate of minimal residual lesion (MRD)

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

• Treatment-related AE

  Induction therapy phase

• Quality of survival of patients in the induction therapy phase

  Induction therapy phase

• Progression-free survival（PFS）

  1 year after study completion

• Overall survival (OS)

  1 year after study completion

Study Arms (2)

Reduced-dose Chemotherapy Followed by Blinatumomab

EXPERIMENTAL

Reduced-dose Chemotherapy(including 1 dose of Idarubicin 8 mg/m2, 1 dose of Vincristine 1.4 mg/m2\[max 2mg\], and 7 days of Dexamethasone 9 mg/m2/d) followed by 2 weeks of Blinatumomab (9 ug/d d8-14, 28 ug/d d15-21) immediately. If not achieved CR/CRi, Blinatumomab 28 ug for another 14 days should be continued.

Drug: Blinatumomab Injection [Blincyto]

hyperCVAD

ACTIVE COMPARATOR

CTX 300mg/m2 q12h D1-3 VCR 1.4mg/m2 (max 2mg) D4,D11 DNR 50mg/m2, D4 DEX 40mg/d D1-4, D11-14

Drug: Doxorubicin

Interventions

Blinatumomab Injection [Blincyto] DRUG

Reduced-intensity chemotherapy followed by Blinatumomab

Reduced-dose Chemotherapy Followed by Blinatumomab

Doxorubicin DRUG

HyperCVAD regimen

hyperCVAD

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine ·aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration)
• Renal function: endogenous creatinine clearance ≧30ml/min
• Patients must be able to understand and willing to participate in the study and must sign the informed consent form.

You may not qualify if:

• Ph+ (BCR-ABL1 positive) ALL
• T cells ALL
• Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease
• Acute mixed-cell leukemia
• Central nervous system leukemia
• HIV infection
• HBV-DNA or HCV-RNA positive
• Pregnant or breastfeeding patients
• The study patient was refused enrollment

Sponsors & Collaborators

• Chen Suning: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

blinatumomab; Doxorubicin

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Jing Lu, MD

  Soochow U

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Lu

CONTACT

1377183627; lujing@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: February 5, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year after the publication of the summary paper

Locations

CN (1)