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Inotuzumab as Post-Trasplantation Therapy for Adult High-risk B-cell Precursor Acute Lymphoblastic Leukemia

ConditionsAcute Lymphobkastic LeukemiaAdult
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPETHEMA Foundation

About this trial

The goal of this clinical trial is to learn if Inotuzumab Ozogamicin works to prevent relapses after transplantation in adult high-risk B-cell precursor acute lymphoblastic leukemia treated with the PETHEMA ALL-2025 protocol.

The main questions it aims to answer are:

* Do patients receiving Inotuzumab ozogamicin post-transplantation suffer less relapses than those patients not receiving this therapy (control group) within the ALL-2025 protocol? * Do patients receiving Inotuzumab ozogamicin show more adverse events and severe adverse events related with this treatment than those patients no receiving this intervention (control group)? Researchers will compare the relapse rate between patients receiving Inotuzumab Ozogamicin post-transplantation and patients not receiving Inotuzumab Ozogamicin post-trasnplantation within the ALL-2025 protocol.

Participants will receive 3 cycles of Inotuzumab Ozogamicin therapy. Treatment will be initiated from day +70 post-transplantation and a minimum interval of 30 days between consecutive administrations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is, in the investigator's opinion, willing and able to adhere/comply with visit schedule and other protocol requirements.

Patient must be able to understand the study procedures.

Patients aged ≥18 years at the time of signing the informed consent form.

Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.

Disqualifiers

Prior exposure to inotuzumab ozogamicin or known hypersensitivity to inotuzumab ozogamicin or to any of its excipients.

Ph-positive lymphoblastic leukemia

Cord blood HSCT.

Creatinine clearance <30 ml/minute.

Trial design

Design model

Single group

Treatments tested in this trial

  • Inotuzumab Ozogamicin (IO)

    Drug

    Three doses of 0,5mg/m2 of Inotuzumab Ozogamicin will be given to participants at day +70 post-transplantation and a minimum interval of 30 days between consecutive administrations. All patients will receive treatment until treatment is completed, unacceptable toxicity, disease progression, patient withdrawal, loss of follow-up, end of study, study completion, or death, whichever is first.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Inotuzumab OzogamicinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy of Inotuzumab Ozogamicin (InO) in the prevention of relapse in terms of the relapse rate

Evaluation of the efficacy of InO in terms of relapse rate, defined as percentage of patients who experience a relapse after achieving complete remission.

Time frame
24 months
2

Efficacy of InO in the prevention of relapse in terms of the cumulative incidence of relapse (CIR)

Evaluation of the efficacy of InO in terms of CIR, defined as time interval between the date of complete remission and the date of relapse, considering any death not related to relapse as a competing event.

Time frame
24 months
3

Efficacy of InO in the prevention of relapse in terms of the disease-free survival (DFS).

Evaluation of the efficacy of InO in terms of DFS, defines as time interval between the date of complete remission and relapse, death from any cause or last follow-up.

Time frame
24 months

Secondary outcomes

1

Safety profile of treatment with InO after allogeneic hematopoietic stem cell trasnplantation (allo-HSCT) in terms of side effects, adverse events (AEs) and serious AEs (SAEs) related to treatment

The safety profile of the treatment will be assessed based on: * Incidence of AEs. * Percentage of patients discontinuing therapy due to AEs. * Percentage of patients requiring dose modifications due to AEs. * Incidence of SAEs. * Changes in laboratory analysis from the hematology and blood chemistry panel. * Incidence of deaths and primary cause of death. A safety analysis will be performed in the first five patients with special consideration of haematological and hepatic toxicity.

Time frame
24 months
2

Centralized study the minimal residual disease (MRD) in bone marrow (BM)

MRD will be centrally analized in BM prior to drug administration, as well as at 3-, 6-, 9-, 12-, 18- and 22-months post allo-HSCT by Next Generation Flow Cytometry. Negative MRD will be considered when there is \<0.01% of leukemic cells among all cell counts.

Time frame
22 months
3

Analysis of the immune reconstitution in peripheral blood

Analysis of the immune reconstitution in peripheral blood prior to drug administration and at 3-, 6-, 9-, 12-, 18- and 22-months post allo-HSCT, evaluated by immunophenotypic study (NGF) of specific markers of B-cells, T-cells and myeloid cells, among others.

Time frame
22 months
4

Analyse the cumulative incidence of graft failure and acute and chronic graft-versus-host disease (GVHD).

Analysis of the cumulative incidence of graft failure, defined as time interval from allo-HSCT to graft failure (failure to achieve sustained engraftment of donor cells). Cumulative incidence of acute GVHD (aGVHD), defined as time interval from allo-HSCT to aGVHD, staged and graded according to the MAGIC criteria previously published. Cumulative incidence of chronic GVHD (cGVHD) as time interval from allo-HSCT to cGVHD, based on the NIH criteria previously published.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PETHEMA Foundation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: