Reduced-Dose Chemo Followed by 14 Days of Blinatumomab for Newly Diagnosed Adult B-ALL Patients: … (NCT06649422) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Reduced-Dose Chemo Followed by 14 Days of Blinatumomab for Newly Diagnosed Adult B-ALL Patients: a Multicenter Study
36 participantsStarted 2024-11-01
Plain-language summary
This is a prospective, multicenter, observational study aimed at exploring the efficacy and safety of reduced-dose chemotherapy followed by frontline therapy with blinatumomab in patients aged 15-65 with newly diagnosed Ph-negative B-ALL.
Who can participate
Age range15 Years – 65 Years
SexALL
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Inclusion Criteria:
* Age 15-65 years, both male and female are eligible;
* Untreated newly diagnosed Ph-negative B-ALL patients; Diagnosis is defined by using morphological, immunological, cytogenetic, and molecular (MICM) diagnostic models, with immunotyping showing \>20% primitive lymphoid cells in the bone marrow; bone marrow cytogenetics showing Philadelphia chromosome (Ph) negative (after observing at least 20 metaphases) and/or fluorescence in situ hybridization (FISH) BCR/ABL negative and/or molecular BCR/ABL fusion gene negative;
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2;
* Organ function tests must meet all the following criteria: Total bilirubin \<1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \<2.5×ULN (if liver is involved, then ALT and AST \<5×ULN are allowed); Creatinine \<1.5×ULN; Serum amylase and lipase ≤1.5×ULN; Alkaline phosphatase ≤2.5× ULN; Serum electrolytes potassium, magnesium, phosphorus within normal limits.
* Cardiac color Doppler echocardiography ejection fraction ≥45%;
* Female patients of childbearing potential must have a negative pregnancy test (within 7 days prior to enrollment).
Exclusion Criteria:
* Previous or ongoing systemic anti-acute lymphoblastic leukemia (ALL) treatment (including but not limited to radiotherapy), except for appropriate pretreatment;
* Clinical manifestations of central nervous system or extramedullary involvement at the time of d…
What they're measuring
1
The overall response rate
Timeframe: At the end of induction treatment from day 28 to day 35
2
Minimal Residual Disease (MRD) negativity rate after induction therapy
Timeframe: At the end of induction treatment from day 28 to day 35