CompletedPhase 2

Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma

United States80 participantsStarted 2013-04-15

Plain-language summary

The overall objective of this protocol is to improve the cure rate of relapsed precursor B-cell acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma. This phase II trial is studying risk-directed therapy for B-lymphoblastic leukemia or lymphoma in first relapse. Standard risk (SR) and high risk (HR) participants will receive different therapy. Treatment will consist of chemotherapy for SR participants, and chemotherapy followed by hematopoietic stem cell transplant (HSCT) for HR in first relapse. Induction therapy consists of three blocks of chemotherapy. The first block is a novel immunotherapy regimen that includes chemotherapy, rituximab and infusion of haploidentical natural killer (NK) cells. SR participants will continue to receive chemotherapy for a total duration of approximately 2 years. HR participants will be candidates for HSCT and will proceed to transplant once a suitable donor is found and their minimal residual disease (MRD) is negative.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. In first hematologic relapse, defined as the reappearance (in a patient who has previously achieved remission) of leukemia blasts in the bone marrow or peripheral blood, OR
✓. Refractory to one or two courses of frontline induction therapy (≥ 5% blasts in the bone marrow or peripheral blood confirmed by flow cytometric analysis).
✓. In first relapse, OR
✓. Refractory to one or two courses of frontline induction therapy with measurable disease
✓. There is no waiting period for participants who relapse while receiving frontline therapy and are free from side effects attributable to such therapy.
✓. Emergent radiation therapy, one dose of intrathecal chemotherapy, and up to 7 days of steroids for treatment of relapse are permitted before start of treatment in participants who relapse after completion of frontline therapy.
✓. At least 90 days have elapsed since bone marrow transplant and participant is off immune suppression for a minimum of 2 weeks, if applicable. Participants with ALL or NHL who were transplanted in first remission are eligible for this study.

What they're measuring

3-year Overall Survival Rate of Patients With Relapsed ALL

Timeframe: 3 years of follow-up since the on-study date

3-year Event-free Survival Rates in Patients With Relapsed ALL

Timeframe: 3 years of follow-up since the on-study date

Trial details

NCT IDNCT01700946

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-24

Results submitted2022-06-07

View on ClinicalTrials.gov More Recurrent B-Cell Childhood Acute Lymphoblastic Leukemia trials