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Clinical Trials/EUCTR2016-001991-31-IT
EUCTR2016-001991-31-IT
Active, not recruiting
Phase 1

Phase IIIb study for relapsed/refractory pediatric/young adult acute lymphoblastic leukemia patients to be treated with CTL019. - Phase IIIb study for CTL019

OVARTIS PHARMA AG0 sites74 target enrollmentMay 24, 2021
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ConditionsPaediatric/young adult patients with B-cell acute lymphoblastic leukaemia who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic SCT.MedDRA version: 21.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10063621Term: Acute lymphoblastic leukaemia recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsROACTEMRA - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 10 ML 1 FLACONCINOROACTEMRA - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 4ML 1 FLACONCINOSYLVANT - 400 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINOCITARABINA ACCORD - 100 MG/ML SOLUZIONE INIETTABILE O PER INFUSIONE 5 FLACONCINI IN VETRO DA 5 ML

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Paediatric/young adult patients with B-cell acute lymphoblastic leukaemia who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic SCT.
Sponsor
OVARTIS PHARMA AG
Enrollment
74
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 24, 2021
End Date
October 13, 2020
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients eligible for inclusion in this program have to meet all of the following criteria:
  • •1\. Relapsed or refractory B\-cell ALL in pediatric or young adult patients:
  • •a. Second or greater bone marrow relapse, OR
  • •b. Any bone marrow relapse after allogeneic SCT and must be \= 6
  • •months from SCT at the time of CTL019 infusion, OR
  • •c. Primary refractory as defined by not achieving a CR after 2 cycles of a
  • •standard chemotherapy regimen or chemorefractory as defined by not
  • •achieving a CR after 1 cycle of standard chemotherapy for relapsed
  • •leukemia, OR
  • •d. Patients with Philadelphia chromosome positive (Ph\+) ALL are eligible

Exclusion Criteria

  • •1\. Isolated extra\-medullary disease relapse.
  • •2\. Patients with concomitant genetic syndromes.
  • •3\. Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B\-cell ALL, leukemia with B\-cell \[sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation).
  • •4\. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.
  • •5\. Treatment with any prior gene therapy product.
  • •6\. Prior treatment with any anti\-CD19/anti\-CD3 therapy, or any other anti\-CD19 therapy, except for patients pre\-treated with blinatumomab
  • •who fulfill inclusion criterion no. 8\.
  • •7\. Presence of active replication of hepatitis B or hepatitis C (for detailed criteria see Appendix 2 of main protocol). Serology must be repeated, if the interval between testing at Screening and CTL019 infusion exceeds 8 weeks.
  • •8\. HIV positivity as indicated by serology. Serology must be repeated, if the interval between testing at Screening and CTL019 infusion exceeds 8 weeks.
  • •9\. Presence of grade 2 to 4 acute or extensive chronic graft\-versus\-host disease.

Outcomes

Primary Outcomes

Not specified

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A clinical study to provide the opportunity to be treated with CTL019, an investigational gene therapy, for children and adolescent patients with a recurrent form of B-cell acute lymphoblastic leukaemia after the closure of the Novartis single-arm phase II pivotal registration trial (Study CCTL019B2202) and to collect additional safety information.Paediatric/young adult patients with B-cell acute lymphoblastic leukaemia who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic SCT.MedDRA version: 21.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10063621Term: Acute lymphoblastic leukaemia recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
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