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Clinical Trials/EUCTR2017-002853-13-DE
EUCTR2017-002853-13-DE
Active, not recruiting
Phase 1

Phase II trial for the treatment of older patients with newly diagnosed CD19 positive, Ph/BCR-ABL negative B-precursor acute lymphoblastic leukemia with sequential dose reduced chemotherapy and Blinatumomab(EWALL-BOLD) - EWALL-BOLD

Goethe Universität Frankfurt0 sites30 target enrollmentOctober 17, 2017
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ConditionsPatient aged 56 and 74 with CD19 positive, Ph/BCR-ABL negative B-precursor acute lymphoblastic leukemiaMedDRA version: 21.1Level: LLTClassification code 10066109Term: Precursor B-lymphoblastic leukemia acuteSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsBlincyto

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patient aged 56 and 74 with CD19 positive, Ph/BCR-ABL negative B-precursor acute lymphoblastic leukemia
Sponsor
Goethe Universität Frankfurt
Enrollment
30
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 17, 2017
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Goethe Universität Frankfurt

Eligibility Criteria

Inclusion Criteria

  • •1\. Newly diagnosed patients with CD19 positive B–precursor ALL
  • •2\. Greater than 25% blasts in the bone marrow
  • •3\. Eastern Cooperative Oncology Group (ECOG) performance status \= 2
  • •4\. Charlson comorbidity score \= 2
  • •5\. Age \>55 and \<75 years at the time of informed consent\*
  • •6\. Renal and hepatic function as defined below:
  • •\- AST (SGOT), ALT (SGPT), and AP \< 5 x upper limit of normal (ULN) (unless related to leukemic liver infiltration by investigator assessment)”
  • •\- Total bilirubin \< 1\.5 x ULN (unless related to Gilbert's Meulengracht disease)
  • •\- Creatinine \< 1\.5x ULN
  • •\- Creatinine clearance \> 50 mL/min (e.g. calculated according Cockroft \& Gault)

Exclusion Criteria

  • •1\. Antileukemic pretreatment (GMALL prephase with dexamethasone and cyclophosphamide allowed)
  • •2\. History of malignancy other than ALL within 5 years prior to start of protocol\-specified therapy with the exception of:
  • •\- Malignancy treated with curative intent and with no known active disease present for 2 years before enrollment and felt to be at low risk for recurrence by the treating physician including
  • •\- Adequately treated non\-melanoma skin cancer or lentigo maligna without evidence of disease
  • •\- Adequately treated cervical carcinoma in situ without evidence of disease
  • •\- Adequately treated breast ductal carcinoma in situ without evidence of disease
  • •\- Prostatic intraepithelial neoplasia without evidence of prostate cancer.
  • •3\. History or presence of clinically relevant (per investigator's assessment) CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, or psychosis
  • •4\. Active ALL in the CNS (confirmed by CSF analysis) or testes (clinical diagnosis) or other extramedullary involvement; non\-bulky lymph node (\< 7\.5 cm diameter) involvement will be accepted.
  • •5\. Current autoimmune disease or history of autoimmune disease with potential CNS involvement

Outcomes

Primary Outcomes

Not specified

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