Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Treatment Optimization in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment - a Phase IV-trial With a Phase III-part to Evaluate Safety and Efficacy of Nelarabine in T-ALL Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02881086
• Other study ID #: GMALL08_2013
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase IV study with the primary goal to optimize therapy of adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma (LBL) by dose and time intensive, pediatric based chemotherapy, risk adapted stem cell transplantation (SCT) and minimal residual disease (MRD) based individualised and intensified therapy. Study will further evaluate the role of asparaginase intensification, the extended use of rituximab and the use of nelarabine as consolidation therapy in T-ALL in a phase III-part of the study. Furthermore two randomisations will focus on the role of central nervous system (CNS) irradiation in combination with intrathecal therapy versus intrathecal therapy only in B-precursor ALL/LBL and the role of SCT in high-risk patients with molecular complete remission. Finally a new, dose reduced induction therapy in combination with Imatinib will be evaluated in Ph/BCR-ABL positive ALL.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: July 2025
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, thymic T, mature T)
• Lymphoblastic lymphoma (B or T-lineage)
• Age 18-55 yrs
• Written informed consent
• Adequate contraception as specified per protocol

Exclusion Criteria:

• Severe comorbidity or leukemia associated complications
• Late relapse of pediatric ALL or ALL as second malignancy
• Cytostatic pre-treatment
• Pregnancy or breast feeding
• Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
• Participation in other clinical trials interfering with the study therapy

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Lymphoblastic Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Rituximab

• Nelarabine

• PEG-Asparaginase

Procedure:
• Cranial irradiation

Drug:
• Imatinib

• Idarubicin

• Dexamethasone

• Cyclophosphamide

• Fludarabine

• Vincristine

• Mercaptopurine

• VP16

• Daunorubicin (DNR)

• Methotrexate

Procedure:
• Stem cell transplantation

Drug:
• Cytarabine

• Vindesine

• Adriamycin

• Prednisolone

Locations

Country	Name	City	State
Germany	University Hospital of Frankfurt (Main)	Frankfurt (Main)

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hematological remission rate		after induction, approximately 6-8 weeks from diagnosis
Other	Molecular remission rate		after induction and consolidation, approximately 6-8 weeks from diagnosis
Other	Results of the positron emission tomography (PET) based remission evaluation		after consolidation, approximately 8-10 weeks
Other	Remission duration		up to 10 years
Other	Relapse rate		up to 10 years
Other	Overall survival		up to 10 years
Other	Relapse location		at timepoint of relapse (up to 10 years)
Other	Early death		during induction, approximately 6-8 weeks from diagnosis
Other	Death in clinical remission (CR)		during treatment, up to approximately 2.5 years from diagnosis
Other	Comorbidities according to Charlson Score		up to 2.5 years
Other	Quality of life assessed by QLQ-C30		up to 2.5 years
Other	Eastern Cooperative Oncology Group (ECOG) under therapy		up to 2.5 years
Other	Toxicity assessed by CTCAE v4.03		up to 2.5 years
Other	Results of the Dementia Detection (DemTect) test		up to 2.5 years
Primary	Event free survival		3.5 years
Secondary	Time until consolidation treatment I		approximately 70 days
Secondary	Disease free survival		1 year