German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Conditions

Adult Acute Lymphocytic Leukemia

Keywords

ALL, Treatment, Elderly, De novo

Brief summary

The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.

Fabian Lang, Roman Pfeifer, Simon Raffel, Walter Fiedler, Maher Hanoun et al. (12 authors)

HemaSphere2023-08-01

10.1097/01.hs9.0000967368.67660.c6

Outcome of 841 Older Patients (&gt;55 yrs) with Newly Diagnosed Ph/BCR-ABL Negative ALL Prospectively Treated According to Pediatric-Based, Age-Adapted GMALL Protocols

Nicola Goekbuget, Andreas Viardot, Björn Steffen, J. Hahn, Bernd M. Spriewald et al. (20 authors)

Blood2022-11-1516 citations

10.1182/blood-2022-158934

Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL.

Topp MS, Gökbuget N, Zugmaier G, Degenhard E, Goebeler ME, Klinger M, Neumann SA, Horst HA, Raff T, Viardot A, Stelljes M, Schaich M, Köhne-Volland R, Brüggemann M, Ottmann OG, Burmeister T, Baeuerle PA, Nagorsen D, Schmidt M, Einsele H, Riethmüller G, Kneba M, Hoelzer D, Kufer P, Bargou RC.

2012-09-28342 citations

10.1182/blood-2012-07-441030

Interventions

DRUGGranulocyte-Colony-Stimulating Factor

DRUGMercaptopurine

DRUGMethotrexate

DRUGRituximab

DRUGHDARAC

DRUGVincristine

DRUGDepocyte

DRUGIdarubicin

DRUGCyclophosphamide

DRUGDexamethasone / Prednisolone

DRUGCytarabine

DRUGAsparaginase

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Diagnosis of acute lymphoblastic leukemia (pro B, pre B, c-ALL or T-ALL), proved by morphology and immunophenotyping * Age \> 55 yrs (no upper age limit) * Written informed consent

Exclusion criteria

* Severe leukemia associated complications, not controllable before therapy onset e.g. * life threatening infections as sepsis, pneumonia, hypoxia, shock, life threatening bleeding) * Severe comorbidity e.g. * decompensated renal failure if not caused by leukemia with Creatinine \> 2x ULN * heart failure (NYHA II/IV), instable Angina, significant coronary stenosis * hepatic insufficiency e.g. liver cirrhosis or chronic active hepatitis with bilirubin \> 1,5 x ULN and/or ASA, ALA, AP \> 2,5 ULN * decompensated metabolic disturbances (e.g. not controllable diabetes) * severe obstructive or restrictive pulmonary disease with hypoxaemia * Severe psychiatric illness or other circumstances which may compromise cooperation of the patient * Active second neoplasia * HIV infection * Severely reduced general condition * Cytostatic pre-treatment of ALL * Chemotherapy treatment of any other malignancy during the last 5 years * Participation in other clinical trials interfering with the study therapy

Design outcomes

Primary

Measure	Time frame
Remission rate (cytologic, molecular)	After induction; approximately 6 wks (exact time frame not specified)
Toxicity (CTC)	After each cycle; time-frame not specified
Survival time, Duration of Remission	at 3 and 5 years

Countries

Germany

Outcome results

None listed