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RecruitingPhase 2

Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests giving chemotherapy into the fluid around the brain and spinal cord before and during blinatumomab treatment. It aims to reduce harm to the nervous system while keeping blinatumomab working against leukemia. It is for adults starting blinatumomab for B-cell acute lymphoblastic leukemia (ALL) that has returned, has not responded to treatment, or remains at very low levels after treatment.

Changing the schedule of intrathecal chemotherapy to be given before and during blinatumomab will maintain the anti-leukemic effects of this drug while at the same time adding the benefit of limiting the neurotoxicity associated with cytokine release.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Starting the first cycle of blinatumomab for B-cell ALL that has returned, has not responded to treatment, or remains at very low levels after treatment.
  • Must be an adult.
  • Kidneys and liver work well enough.
  • Test negative for HIV.
  • Have a negative blood pregnancy test, if needed.
  • Can care for yourself and are up and about for at least half of your waking hours (ECOG score 0–2).

Who can't join

  • ALL is currently affecting the brain or spinal cord.
  • Have certain nervous system or mental health conditions, such as seizures, weakness, trouble speaking, stroke or brain bleeding, severe brain injury, dementia, Parkinson’s disease, psychosis, or problems with balance, coordination, or movement.
  • Cannot safely receive methotrexate chemotherapy into the fluid around the brain and spinal cord.
  • Have received blinatumomab before.
  • Have another active cancer besides ALL.
  • Have an active infection or another illness or medical condition that the study doctor thinks would interfere with the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Adults receiving first cycle of blinatumomab for relapse/refractory or MRD-positive B-cell Acute Lymphoblastic Leukemia * Adequate renal and hepatic function * Negative for HIV * Negative serum pregnancy test, if applicable * ECOG 0-2 Exclusion Criteria: * Active CNS involvement by ALL * Relative CNS disorders (seizure, paresis, aphasia, Cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, Parkinson's, cerebellar disease, psychosis, coordination or movement disorder) * Contraindication to receive intrathecal methotrexate * Prior treatment with blinatumomab * Active malignancy other than ALL * Active infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator

Study sites (1)

GA