Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Blinatumomab for B Acute Lymphoblastic Leukemia

This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

Official registry: https://clinicaltrials.gov/study/NCT02877303 · M.D. Anderson Cancer Center · enrollment listed as 80

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Blinatumomab, Cyclophosphamide, or Cytarabine. The registry lists allocation as na. This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia.

They plan to enroll about 80 people at Houston. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab With or Without Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia

Interventions: Blinatumomab, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin Hydrochloride, Inotuzumab Ozogamicin, Laboratory Biomarker Analysis, Mercaptopurine, Methotrexate, Ofatumumab, Prednisone, Rituximab, Vincristine Sulfate

Primary outcome (registry wording): Relapse-free survival (RFS)

Who it is for (from inclusion criteria)

  • Ages 14 Years to any
  • Failure to one induction course of chemotherapy (these patients will be analyzed separately); patients who require steroids, ara-c or hydrea to manage disease symptoms prior to finalization of diagnosis and treatment plan are allowed and eligible
  • Performance status of 0-3
  • Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related)
  • Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related)
  • Adequate cardiac function as assessed by history and physical examination
  • No active or co-existing malignancy with life expectancy less than 12 months, sources for the determination of clinical significance by the treating physician will be included in the subject's medical record

Public study contact (from the registry)

Elias Jabbour

713-792-4764

ejabbour@mdanderson.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT02877303 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT02877303?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT02877303?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary