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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

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Krankenanstalten Gilead gCmbH Neurochirurgische Klinik
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BielefeldGermanyUnknown status
Klinikum Bremen-Mitte
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BremenGermanyUnknown status
Universitaetsklinikum Duesseldorf
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DüsseldorfGermanyUnknown status
Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald
Coordinator of this site? Confirm its status
GreifswaldGermanyUnknown status
University Medical Center Hamburg-Eppendorf
Coordinator of this site? Confirm its status
HamburgGermanyUnknown status
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Coordinator of this site? Confirm its status
Idar-ObersteinGermanyUnknown status
Klinikum Krefeld GmbH
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KrefeldGermanyUnknown status
Universitaets - Kinderklinik
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LeipzigGermanyUnknown status
Johannes Gutenberg University
Coordinator of this site? Confirm its status
MainzGermanyUnknown status
Dr. von Haunersches Kinderspital der Universitaet Muenchen
Coordinator of this site? Confirm its status
MunichGermanyUnknown status
Staedtisches Krankenhaus Muenchen - Harlaching
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MunichGermanyUnknown status
Klinik St. Hedwig-Kinderklinik
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RegensburgGermanyUnknown status
Dr. Horst Schmidt Kliniken
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WiesbadenGermanyUnknown status
Helios Kliniken Wuppertal University Hospital
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WuppertalGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.