A Phase 2, Multicenter Study in Pediatric Subjects with Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma

Conditions: Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma of B-cell Origin
MedDRA version: 16.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864
MedDRA version: 16.0Level: LLTClassification code 10003939Term: B-lymphoblastic lymphoma (Kiel Classification)System Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-003101-10-ES

Lead Sponsor: MedImmune, LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 76

Inclusion Criteria

Subjects must meet all of the following criteria:
1) Between the ages of >/= 6 months and < 18 years of age
2) Written informed consent and written informed assent (if applicable)
3) Must have histologically proven B-cell ALL or B-cell lymphoblastic lymphoma
4) Measurable or evaluable disease
5) Disease status:
- Subjects must have relapsed or refractory disease and received at least 1 standard chemotherapy and either 1 salvage regimen or allogeneic HSCT.
- In event of relapse after prior allogeneic HSCT, subjects must be at least 3 months post-transplant, have no evidence of active graft-vs-host disease, and been off immunosuppression for at least 4 weeks
- Must have resolution of the acute toxic effects to 6) For non-leukemic subjects, an absolute neutrophil count (ANC) > 1000/µL, and platelet count > 50,000/mm2 are required, unless cytopenias are judged by the investigator to be due to underlying disease (ie, potentially reversible with anti-neoplastic therapy).
7) Adequate Performance status.
8) Subjects with central nervous system (CNS) status 1 or 2 are eligible only in the absence of neurologic symptoms, such as cranial nerve palsy, suggestive of CNS leukemia.
9) Sexually active subjects must agree to use an approved method of contraception or abstinence to meet eligibility criteria.
Are the trial subjects under 18? yes
Number of subjects for this age range: 76
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any of the following would exclude the subject from participation in the study:
1) Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
2) Concurrent enrollment in another clinical study, unless it is a non-interventional, observational study or the subject is in the follow-up period from a previous study, or prior sponsor approval is obtained
3) Employees of the study site directly involved with the study at the site of enrollment, or immediate family members of such individuals
4) Isolated testicular or CNS ALL
5) Inadequate hepatic function
6) Inadequate renal function
7) Radiologically-detected CNS lymphoma
8) Laboratory findings consistent with Grade >/= 3 disseminated intravascular coagulation (DIC) or any Grade 2 DIC that does not correct
9) Hyperleukocytosis (WBC >/= 50,000/µL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy
10) Pregnant or breast-feeding females
11) Prior treatment with CAT-3888 (BL22), moxetumomab pasudotox, or any pseudomonas-exotoxin-containing compound
12) Prior treatment with any anticancer biologic therapy within 2 weeks prior to enrollment, including but not limited to therapeutic monoclonal antibodies or antibody-drug conjugates
13) Systemic chemotherapy 14) Other investigational antineoplastic agents within 30 days prior to Cycle 1, Dose of study treatment
15) Human immunodeficiency virus (HIV) positive serology
16) Seropositivity for hepatitis B (HBsAg) or hepatitis C (HCV antibody)
17) Clinically significant ophthalmologic findings during the screening
18) Uncontrolled, symptomatic, intercurrent illness that would limit study compliance
19) Presence of a second invasive malignancy
20) Any physical, social, or psychiatric condition, or any other condition which in the opinion of the investigator would prevent effective study cooperation or participation
21) Uncontrolled pulmonary infection, presence of pulmonary edema
22) Inadequate oxygen saturation
23) Serum albumin < 2 g/dL
24) Radioimmunotherapy within 2 years prior to study enrollment
25) Subject with prior history of thrombotic microangiopathy or HUS.