AzTrials
AzTrials

Acute Lymphoblastic LeukemiaPhase 3NCT02881086

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

A Phase 3 study testing Rituximab, Nelarabine and PEG-Asparaginase in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by Goethe University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
Rituximab, Nelarabine and PEG-Asparaginase
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,023 participants
Where
1 siteGermany
Study dates
Aug 2016to Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital of Frankfurt (Main)

    Frankfurt am Main, 60590

Other trials in Germany

About this study

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

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.

Being tested
Rituximab, Nelarabine, PEG-Asparaginase, Cranial irradiation, Imatinib
Keywords
Acute lymphoblastic leukemia, Lymphoblastic lymphoma, Nelarabine, BCR-ABL, MRD, PEG-Asparaginase, Rituximab
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02881086
Study groupRoleWhat they receive
Stratification I - Standard Risk (SR)/ High Risk (HR)OtherInduction and consolidation I therapy for standard and high risk patients, PH/BCR-ABL-negative Chemotherapy, immunotherapy, intrathecal prophylaxis, CNS irradiation according to randomisation I Drugs: Rituximab, Vincristine, Daunorubicin, Dexamethasone, Cyclophosphamide, Cytarabine, Mercaptopurine, PEG-Asparaginase, Methotrexate, Vindesine, VP16
Receives: Drug: Rituximab; Drug: PEG-Asparaginase; Drug: Dexamethasone; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Mercaptopurine; Drug: VP16; Drug: Daunorubicin (DNR); Drug: Methotrexate; Drug: Cytarabine; Drug: Vindesine
Stratification I - Philadelphia (PH)+OtherInduction and consolidation I therapy for PH+ patients Chemotherapy, immunotherapy, intrathecal prophylaxis Drugs: Rituximab, Vincristine, Imatinib, Dexamethasone, PEG-Asparaginase, Cytarabine, Methotrexate, Vindesine, VP16
Receives: Drug: Rituximab; Drug: PEG-Asparaginase; Drug: Imatinib; Drug: Dexamethasone; Drug: Vincristine; Drug: VP16; Drug: Methotrexate; Drug: Cytarabine; Drug: Vindesine
Rand I - B-Lin + CNS Rad + i.th. MTXActive comparatorChemotherapy according to Stratification I SR/HR CNS prophylaxis: CNS irradiation 24 Gy, intrathecal Methotrexate
Receives: Procedure: Cranial irradiation; Drug: Methotrexate
Rand I - B-Lin + i.th. MTXExperimentalChemotherapy according to Stratification I SR/HR CNS prophylaxis: intrathecal Methotrexate
Receives: Drug: Methotrexate
Stratification II - SR + MRD-negOtherChemotherapy, immunotherapy, intrathecal prophylaxis, consolidation II, reinduction, consolidation III - VI, maintenance Drugs: Rituximab, PEG-Asparaginase, Cytarabine, Methotrexate, Vindesine, Adriamycin, Prednisolone, Cyclophosphamide, Nelarabine, Dexamethasone
Receives: Drug: Rituximab; Drug: Nelarabine; Drug: PEG-Asparaginase; Drug: Dexamethasone; Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Cytarabine; Drug: Vindesine; Drug: Adriamycin; Drug: Prednisolone
Stratification II - HR + MRD-negOtherChemotherapy or stem cell transplantation according to randomisation II
Receives: Drug: Rituximab; Drug: Nelarabine; Drug: PEG-Asparaginase; Drug: Cyclophosphamide; Drug: Methotrexate; Procedure: Stem cell transplantation; Drug: Cytarabine; Drug: Vindesine; Drug: Adriamycin; Drug: Prednisolone
Stratification II - SR/HR/PH+ + MRD-posOtherChemotherapy or targeted therapy, followed by stem cell transplantation Drugs: Fludarabine, Idarubicin, Cytarabine, Nelarabine
Receives: Drug: Nelarabine; Drug: Idarubicin; Drug: Fludarabine; Drug: Cytarabine
Randomisation II - HR + MRD-neg-SCTActive comparatorStem cell transplantation
Receives: Procedure: Stem cell transplantation
Randomisation II - HR + MRD-neg-SR-chemoExperimentalChemotherapy, immunotherapy, intrathecal prophylaxis, consolidation II, reinduction, consolidation III - VI, maintenance Drugs: Rituximab, Dexamethasone, PEG-Asparaginase, Cytarabine, Methotrexate, Vindesine, Adriamycin, Prednisolone, Cyclophosphamide, Nelarabine
Receives: Drug: Rituximab; Drug: Nelarabine; Drug: PEG-Asparaginase; Drug: Dexamethasone; Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Cytarabine; Drug: Vindesine; Drug: Adriamycin; Drug: Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event free survival

    Measured: 3.5 years

Secondary outcomes (2)

  1. Time until consolidation treatment I

    Measured: approximately 70 days

  2. Disease free survival

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionDec 2024
  4. Study completionDec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,023 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02881086
Sponsor's protocol ID
GMALL08_2013
Status last verified
Dec 2025
First submitted
4 Aug 2016
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Szczepanowski M, Richter J, Bendig S, Bastian L, Kelm M, Beck V, Beder T, Chitadze G, Kotrova M, Duell J, Faul C, Gartner J, Hartmann A, Kehden B, Penas EMM, Neumann M, Ritgen M, Schrader W, Steffen B, Trautmann H, Viardot A, Burmeister T, Baldus CD, Schwartz S, Gokbuget N, Bruggemann M. CD20 expression dynamics in adult B-cell acute lymphoblastic leukemia and impact on anti-CD20 treatment. J Hematol Oncol. 2026 Jul 20;19(1):52. doi: 10.1186/s13045-026-01832-4.

    PubMed 42477805

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab, Nelarabine and PEG-Asparaginase in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by Goethe University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event free survival (time frame: 3.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02881086, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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