EUCTR2016-001991-31-AT
Active, not recruiting
Phase 1
Phase IIIb study for relapsed/refractory pediatric/young adult acutelymphoblastic leukemia patients to be treated with CTL019 - Phase IIIb study for CTL019.
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]
DrugsKymriah
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
- 80
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
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
- •2\. For relapsed patients, CD19 tumor expression demonstrated in bone
- •marrow or peripheral blood by flow cytometry within 3 months of study
- •entry with adequate organ function.
- •3\. Adequate organ function as defined in the protocol.
- •4\. Life expectancy \> 12 weeks.
- •5\. Age \< 26 years of age at the time of Screening.
- •6\. Karnofsky (age \= 16 years) or Lansky (age \< 16 years) performance status \= 50 at Screening.
Exclusion Criteria
- •EExclusion Criteria:
- •1\. Isolated extra\-medullary disease relapse.
- •2\. Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
- •3\. Patients with Burkitt's lymphoma/leukemia.
- •4\. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.
- •5\. Prior treatment with any 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
Outcomes
Primary Outcomes
Not specified
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