Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL
Recruiting
Phase 2
Interventional Study
Acute Lymphoblastic Leukemia
Measurable Residual Disease (MRD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 – 60
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez · Other
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About This Trial
Detectable measurable residual disease (MRD) is the most important prognostic factor for B-cell acute lymphoblastic leukemia (B-ALL) for overall survival (OS) and disease-free survival (DFS). Patients who are MRD positive and have no access to novel immunotherapies should receive an allogeneic hematopoietic stem cell transplantation (HSCT). Blinatumomab is considered a standard of care (SOC) for t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia
* MRD detectable in complete response (above the limit of quantification according to FCM)
* Performance status 0-2 on the ECOG scale
* No prior organ damage
* Having a potential related or unrelated donor
E…
Contacts