Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01228331 : Clofarabine or High-Dose Cytarabine, Pegaspargase, and Combination Chemotherapy Followed by Daunorubicin Hydrochloride or Doxorubicin Hydrochloride in Treating Young Patients With Acute Lymphoblastic Leukemia
PhasePhase 2/Phase 3
AgesMin: 1 Year Max: 17 Years
Eligibility
DISEASE CHARACTERISTICS:

- Diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) or T-cell ALL* after
October 1st 2009

- No B-cell ALL NOTE: *Patients with non-Hodgkin lymphoma of the T-cell or B-cell
precursor type are included in the observation group.

- Meets 1 of the following risk group criteria:

- Low-risk (LR) disease meeting all of the following criteria:

- WBC < 25/nL at diagnosis

- Age ? 1 to < 10 years

- Common ALL or precursor B-cell ALL

- Complete remission on day 29 (after induction therapy)

- No 11q23 rearrangement

- No hypodiploid chromosome number

- High-risk (HR) disease meeting any of the following criteria:

- WBC ? 25/nL at diagnosis

- Age ? 10 years

- Progenitor B-cell ALL or T-cell ALL

- No complete remission on day 29

- 11q23 rearrangement

- Hypodiploid chromosome number (< 45 chromosomes)

- Must meet 1 of the following criteria regarding minimal-residual disease (MRD):

- LR disease after induction (on day 29):

- LR-reduced (LR-R): MRD negative

- LR-standard (LR-S): MRD positive but < 10^-3 or no evaluable MRD results

- LR-intensified (LR-I): MRD ? 10^-3

- HR disease after induction and intensification ????? (on day 29 and/or day 43):

- HR-reduced (HR-R):

- T-cell ALL: MRD < 10^-3 on day 29

- Precursor B-cell ALL: MRD negative on day 29

- HR-standard (HR-S):

- T-cell ALL: MRD ? 10^-3 on day 29 and < 10^-3 on day 43

- Precursor B-cell ALL: MRD positive on day 29 but < 10^-3 or no
evaluable MRD results

- HR-intensified (HR-I):

- T-cell ALL: MRD ? 10^-3 on day 43

- Precursor B-cell ALL: MRD ? 10^-3 on day 29

- Must be under treatment at 1 of the participating hospitals

- No disease that is a secondary malignancy or relapsed

- After induction, patients with translocation t(9;22) will receive treatment as part
of the European Study on Philadelphia-positive leukemia (EsPhALL)

- bcr-abl-positive patients will be assigned and treated according to different
protocols

PATIENT CHARACTERISTICS:

- No prior severe illness that makes treatment on this study impossible from the outset

- Trisomy 21 (Down syndrome) allowed

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior cytostatic treatment lasting > 7 days

- No prior treatment with drugs other than vincristine sulfate, daunorubicin
hydrochloride, and prednisone
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01228331      |      Link to official Clinicaltrials.gov listing
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