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Adult Acute Lymphocytic LeukemiaPhase 4NCT00198991

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

A Phase 4 study testing Cyclophosphamide, Dexamethasone and Vincristine in people with Adult Acute Lymphocytic Leukemia, 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

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Read more about this study

Who is it for?
Ages 15 to 65 years
Conditions the study is for
Adult Acute Lymphocytic Leukemia
What is being tested?
Cyclophosphamide, Dexamethasone and Vincristine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,883 participants
Where
1 siteGermany
Study dates
Apr 2003to 30 Jun 2013
Phase
Phase 4
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 15 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, thymic T, mature T)
  • Age 15-65 yrs (*55-65 years if biologically younger according to general condition)
  • Written informed consent

Who cannot join

  • Severe comorbidity or leukemia associated complications
  • Late relapse of pediatric ALL or ALL as second malignancy
  • Cytostatic pre-treatment
  • Pregnancy
  • 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 of Frankfurt, Medical Dept. II

    Frankfurt, 60590

Other trials in Germany

About this study

Official title: German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003)

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on the results of MRD evaluation.

Being tested
Cyclophosphamide, Dexamethasone, Vincristine, Daunorubicin, Asparaginase
Keywords
ALL, Treatment, de novo, Minimal residual disease, Adult
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual

What participants receive

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

  • CyclophosphamideDrug

    Cytostatic drug

  • DexamethasoneDrug

    Antileukemic drug

  • VincristineDrug

    Cytostatic drug

  • DaunorubicinDrug

    Cytostatic drug

  • AsparaginaseDrug

    Also called Pegylated Asparaginase

    Cytostatic drug

  • MethotrexateDrug

    Cytostatic drug

  • CytarabineDrug

    Cytostatic drug

  • MercaptopurineDrug

    Cytostatic drug

  • G-CSFDrug

    Growth factor

  • VindesineDrug

    Cytostatic drug

  • EtoposideDrug

    Also called Etoposide Phosphate

    Cytostatic drug

  • PrednisoloneDrug

    Antileukemic drug

  • AdriamycinDrug

    Cytostatic drug

  • ThioguanineDrug

    Cytostatic drug

  • TeniposideDrug

    Cytostatic drug

  • CNS irradiationProcedure or surgery

    Cytostatic drug

  • Mediastinal IrradiationProcedure or surgery

    Irradiation

  • Stem cell transplantation (SCT)Procedure or surgery

    Stem cell transplantation

  • IdarubicinDrug

    Cytostatic drug

  • FludarabineDrug

    Cytostatic drug

  • CladribineDrug

    Cytostatic drug

Study groups in NCT00198991
Study groupRoleWhat they receive
All patientsExperimentalAll patients are treated upfront according to one arm
Receives: Drug: Cyclophosphamide; Drug: Dexamethasone; Drug: Vincristine; Drug: Daunorubicin; Drug: Asparaginase; Drug: Methotrexate; Drug: Cytarabine; Drug: Mercaptopurine; Drug: G-CSF; Drug: Vindesine; Drug: Etoposide; Drug: Prednisolone; Drug: Adriamycin; Drug: Thioguanine; Drug: Teniposide; Procedure: CNS irradiation; Procedure: Mediastinal Irradiation; Procedure: Stem cell transplantation (SCT); Drug: Idarubicin; Drug: Fludarabine; Drug: Cladribine

What is being measured

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

  1. Remission rate

    Rate of patients with complete remission

    Measured: day 46

  2. Remission duration

    Rate and probability of patients with ongoing remission after prior achievement of remission

    Measured: up to 10 years

  3. Disease free survival

    Rate and probability of patients remaining disease free i.e without relapse, death in CR or secondary malignancy

    Measured: up to 10 years

  4. Overall survival

    Rate and probability of patients remaining alive

    Measured: up to 10 years

Secondary outcomes (3)

  1. Realisation of Stem cell transplantation (SCT)

    Rate of patients receiving an SCT

    Measured: up to 10 years

  2. Toxicity according to WHO/CTCAE

    Rate of adverse events according to WHO/CTCAE (cycle duration in this complex protocol is variable and cannot be specified)

    Measured: after each cycle up to 2.5 years

  3. Response assessment based on MRD

    Rate of MRD response after specific cycles

    Measured: up to 5 years

Timeline

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

  1. First posted20 Sep 2005 (estimated)
  2. Study startApr 2003
  3. Primary completion30 Jun 2011
  4. Study completion30 Jun 2013

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,883 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00198991
Sponsor's protocol ID
GMALL01
Status last verified
Aug 2022
First submitted
12 Sep 2005
Last updated
18 Aug 2022
Results posted
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

  • Kobitzsch B, Gokbuget N, Schwartz S, Reinhardt R, Bruggemann M, Viardot A, Wasch R, Starck M, Thiel E, Hoelzer D, Burmeister T. Loss-of-function but not dominant-negative intragenic IKZF1 deletions are associated with an adverse prognosis in adult BCR-ABL-negative acute lymphoblastic leukemia. Haematologica. 2017 Oct;102(10):1739-1747. doi: 10.3324/haematol.2016.161273. Epub 2017 Jul 27.

    PubMed 28751559

  • Herold T, Schneider S, Metzeler KH, Neumann M, Hartmann L, Roberts KG, Konstandin NP, Greif PA, Braundl K, Ksienzyk B, Huk N, Schneider I, Zellmeier E, Jurinovic V, Mansmann U, Hiddemann W, Mullighan CG, Bohlander SK, Spiekermann K, Hoelzer D, Bruggemann M, Baldus CD, Dreyling M, Gokbuget N. Adults with Philadelphia chromosome-like acute lymphoblastic leukemia frequently have IGH-CRLF2 and JAK2 mutations, persistence of minimal residual disease and poor prognosis. Haematologica. 2017 Jan;102(1):130-138. doi: 10.3324/haematol.2015.136366. Epub 2016 Aug 25.

    PubMed 27561722

  • Topp MS, Gokbuget N, Zugmaier G, Degenhard E, Goebeler ME, Klinger M, Neumann SA, Horst HA, Raff T, Viardot A, Stelljes M, Schaich M, Kohne-Volland R, Bruggemann M, Ottmann OG, Burmeister T, Baeuerle PA, Nagorsen D, Schmidt M, Einsele H, Riethmuller G, Kneba M, Hoelzer D, Kufer P, Bargou RC. Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL. Blood. 2012 Dec 20;120(26):5185-7. doi: 10.1182/blood-2012-07-441030. Epub 2012 Sep 28.

    PubMed 23024237

  • Gokbuget N, Stanze D, Beck J, Diedrich H, Horst HA, Huttmann A, Kobbe G, Kreuzer KA, Leimer L, Reichle A, Schaich M, Schwartz S, Serve H, Starck M, Stelljes M, Stuhlmann R, Viardot A, Wendelin K, Freund M, Hoelzer D; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Outcome of relapsed adult lymphoblastic leukemia depends on response to salvage chemotherapy, prognostic factors, and performance of stem cell transplantation. Blood. 2012 Sep 6;120(10):2032-41. doi: 10.1182/blood-2011-12-399287. Epub 2012 Apr 4.

    PubMed 22493293

  • Gokbuget N, Kneba M, Raff T, Trautmann H, Bartram CR, Arnold R, Fietkau R, Freund M, Ganser A, Ludwig WD, Maschmeyer G, Rieder H, Schwartz S, Serve H, Thiel E, Bruggemann M, Hoelzer D; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Adult patients with acute lymphoblastic leukemia and molecular failure display a poor prognosis and are candidates for stem cell transplantation and targeted therapies. Blood. 2012 Aug 30;120(9):1868-76. doi: 10.1182/blood-2011-09-377713. Epub 2012 Mar 22.

    PubMed 22442346

  • Burmeister T, Meyer C, Schwartz S, Hofmann J, Molkentin M, Kowarz E, Schneider B, Raff T, Reinhardt R, Gokbuget N, Hoelzer D, Thiel E, Marschalek R. The MLL recombinome of adult CD10-negative B-cell precursor acute lymphoblastic leukemia: results from the GMALL study group. Blood. 2009 Apr 23;113(17):4011-5. doi: 10.1182/blood-2008-10-183483. Epub 2009 Jan 14.

    PubMed 19144982

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cyclophosphamide, Dexamethasone and Vincristine in people with Adult Acute Lymphocytic Leukemia, 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 3 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 18 Aug 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Remission rate (time frame: day 46). The study lists 4 primary outcomes in all. 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 NCT00198991, which also lists 7 linked publications.

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 18 Aug 2022.

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