Salvage therapy with chemotherapy and Natural Killer cells in relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.

Salvage therapy with chemotherapy and Natural Killer cells in relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma. - NK cells in leukemia / lymphoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000054-63-ES

Enrollment

Unknown

Registered

2012-01-27

Start date

2012-07-25

Completion date

Unknown

Last updated

2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.

Interventions

Product Name: NK cells Pharmaceutical Form: Injection INN or Proposed INN: NK cells Other descriptive name: Natural killer cells Concentration unit: Other Concentration type: not less then Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients betweem 0 and 21 years of age with diagnosis of acute lymphoblastic T leukemia or lymphoma, relapsed or refractary. 2. Lansky index > 60% 3. Left ventricular ejection fraction > 39% 4. Negative HIV serology Are the trial subjects under 18? yes Number of subjects for this age range: 6 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients with history of bad therapeutical compliance 2. Patients not valid after psycho-social evaluation 3. Severe (4) functional organ disorders (hepatic, renal, respiratory) according to NCI CTCAE v4 criteria 4. Should be considered the contraindications, drug interactions, precautions for use and dose reductions indicated in the corresponding Summary of Product Characteristics (SmPC) (read the SmPC)

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this clinical trial is to assess the toxicity of activated and expanded NK cell immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute lymphoblast leukemia/lymphoblast lymphoma (LLT).;Secondary Objective: . Analyze incidence of episodes of febrile neutropenia, bacteremia, infections (viral and fungal), days of isolation, hematological recovery and days of hospitalization. . Assess rate of complete remission (cytomorphological and by criteria of "minimal residual disease") . Assess immune reconstitution of lymphocytes and cytotoxic activity of NK cells pre and post NKAES infusion;Primary end point(s): Safety of NK cells infusion after chemotherapy;Timepoint(s) of evaluation of this end point: 2 months after end infusion	—

Measure

Time frame

Main Objective: The objective of this clinical trial is to assess the toxicity of activated and expanded NK cell immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute lymphoblast leukemia/lymphoblast lymphoma (LLT).;Secondary Objective: . Analyze incidence of episodes of febrile neutropenia, bacteremia, infections (viral and fungal), days of isolation, hematological recovery and days of hospitalization. . Assess rate of complete remission (cytomorphological and by criteria of "minimal residual disease") . Assess immune reconstitution of lymphocytes and cytotoxic activity of NK cells pre and post NKAES infusion;Primary end point(s): Safety of NK cells infusion after chemotherapy;Timepoint(s) of evaluation of this end point: 2 months after end infusion

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Secondary

Measure	Time frame
Secondary end point(s): Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections Days of isolation, hematological recovery (neutrophils >500/?l, lymphocytes >250/ ?l and platelets >50.000/?l), days of hospitalization in each cycle Immune reconstitution In vitro NK cells cytotoxic activity Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR) at the end of the treatment;Timepoint(s) of evaluation of this end point: End of infusion and follow-up (2 months and 1 year)	—

Measure

Time frame

Secondary end point(s): Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections Days of isolation, hematological recovery (neutrophils >500/?l, lymphocytes >250/ ?l and platelets >50.000/?l), days of hospitalization in each cycle Immune reconstitution In vitro NK cells cytotoxic activity Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR) at the end of the treatment;Timepoint(s) of evaluation of this end point: End of infusion and follow-up (2 months and 1 year)

—

Countries

Spain

Contacts

Public ContactSERVICIO ONCOHEMATOLOGIA

HOSPITAL UNIVERSITARIO NINO JESUS

aperezm.hnjs@salud.madrid.org34915035900

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026