NCT01228331CompletedPhase 2/3
Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL
A Randomized Multi-Center Treatment Study (COALL 08-09) to Improve the Survival of Children with Acute Lymphoblastic Leukemia on Behalf of the German Society of Pediatric Hematology and Oncology
Source: ClinicalTrials.gov · Last updated 11 Dec 2024
Brief summary (registry, in English)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than once drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. It is not yet known whether giving clofarabine or high-dose cytarabine, pegaspargase, and combination chemotherapy followed by daunorubicin hydrochloride or doxorubicin hydrochloride is more effective in treating young patients with acute lymphoblastic leukemia. PURPOSE: This randomized phase II/III trial is studying the side effects of giving clofarabine compared with giving high-dose cytarabine, pegaspargase, and combination chemotherapy followed by daunorubicin hydrochloride or doxorubicin hydrochloride and to see how well it works in treating young patients with T-cell acute lymphoblastic leukemia or precursor B-cell acute lymphoblastic leukemia.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 745 (actual)
- First submitted
- 23 Oct 2010
- Start date
- 1 Oct 2010
- Primary completion date
- 31 Dec 2019
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- NCT number
- NCT01228331
- EudraCT number
- 2009-012758-18
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 745
- From 1 Oct 2010 to the primary completion date, 31 Dec 2019
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- BCR/ABL rearrangement positive OR prior cytostatic treatment lasting \> 7 days or prior treatment with cytostatic drugs other than vincristine, daunorubicin and prednisone OR prior severe illnesses which make treatment per the protocol impossible from the outset (BUT trisomy 21 is not an exclusion criterion) OR absence of the baseline data required for assignment to a risk group in accordance with the protocol (BUT patients for whom the MRD value could not be determined for technical reasons will be treated as protocol patients) OR the disease is a secondary malignancy or relapse OR death before the start of treatment
Who the study is looking for
- diagnosis after the first and before the 18th birthday AND confirmed diagnosis of acute B-precursor or or T-cell leukemia AND parents or guardians/patients give consent for inclusion in the study and transmission of data AND if none of exclusion criteria is accomplished
Age in the registry: 1 year to 17 years · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Krankenanstalten Gilead gCmbH Neurochirurgische Klinik Coordinator of this site? Confirm its status | Bielefeld | Germany | Unknown status |
| Klinikum Bremen-Mitte Coordinator of this site? Confirm its status | Bremen | Germany | Unknown status |
| Universitaetsklinikum Duesseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald Coordinator of this site? Confirm its status | Greifswald | Germany | Unknown status |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Clinic for Bone Marrow Transplantation and Hematology and Oncology Coordinator of this site? Confirm its status | Idar-Oberstein | Germany | Unknown status |
| Klinikum Krefeld GmbH Coordinator of this site? Confirm its status | Krefeld | Germany | Unknown status |
| Universitaets - Kinderklinik Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Johannes Gutenberg University Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Dr. von Haunersches Kinderspital der Universitaet Muenchen Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Staedtisches Krankenhaus Muenchen - Harlaching Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Klinik St. Hedwig-Kinderklinik Coordinator of this site? Confirm its status | Regensburg | Germany | Unknown status |
| Dr. Horst Schmidt Kliniken Coordinator of this site? Confirm its status | Wiesbaden | Germany | Unknown status |
| Helios Kliniken Wuppertal University Hospital Coordinator of this site? Confirm its status | Wuppertal | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.