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CompletedNCT00199004Updated Aug 23, 2010

Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab

A Phase 4 interventional study of Cyclophosphamide and Dexamethasone / Prednisolone in Adult Acute Lymphocytic Leukemia, sponsored by Johann Wolfgang Goethe University Hospital. Completed at 1 site in Germany. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-08-23.

Sponsored by Johann Wolfgang Goethe University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
15 Years to 65 Years
Sex
All
01

Study summary

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy in combination with rituximab in CD20 positive standard risk patients. Thereafter patients receive additional consolidation and reinduction cycles combined with rituximab. In parallel minimal residual disease is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on results of MRD evaluation

02

Conditions studied

  • Adult Acute Lymphocytic Leukemia

Keywords

  • ALL
  • Treatment
  • De novo
  • Minimal residual disease
  • Rituximab
  • Adult
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 60 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Johann Wolfgang Goethe University Hospital is the lead sponsor of 158 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • B-precursor ALL (common / pre B-ALL)
  • Standard risk
  • CD20 expression >20%
  • Ph/BCR-ABL negative
  • Age 15-65 years (55-65 if biologically younger)
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Severe complications due to leukemia or secondary illnesses
  • Late relapse of childhood ALL
  • Cytostatic pretreatment
  • Pregnancy
  • Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
  • Known severe allergy to foreign proteins
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Interventions

  • DrugCyclophosphamide
  • DrugDexamethasone / Prednisolone
  • DrugVincristine
  • DrugDaunorubicin
  • DrugAsparaginase
  • DrugMethotrexate
  • DrugCytarabine
  • DrugMercaptopurine
  • DrugG-CSF
  • DrugVindesine
  • DrugVP16
  • DrugAdriamycin
  • DrugThioguanine
  • DrugVM26
  • DrugRituximab
  • ProcedureCNS irradiation
  • ProcedureMediastinal irradiation (if residual TU)
  • ProcedureStem cell transplantation
06

What researchers measure

Primary outcomes

  1. Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival

Secondary outcomes

  1. Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD

07

Study locations

1 site
  • University Hospital of Frankfurt, Medical Dept. II
    Frankfurt, 60590, Germany
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00199004
Lead sponsor
Johann Wolfgang Goethe University Hospital
First posted
Sep 20, 2005
Start date
Apr 2004
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Aug 23, 2010

Study contacts

Dieter Hoelzer, MD,PhD
study chair · University Hospital, Medical Dept. II
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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