Nüksetmiş B Hücreli Akut Lenfoblastik Lösemisi Olan Genç Hastaların Tedavisinde Düşük Doz veya Yüksek Doz Vincristine ve Kombinasyon Kemoterapisi

Sade dilde özet

Bu çalışma, nüksetmiş (tekrarlamış) B hücreli akut lenfoblastik lösemi (B-cell acute lymphoblastic leukemia) olan genç hastalarda düşük veya yüksek doz vincristine ile birlikte çeşitli kemoterapi ilaçlarının kullanımını incelemektedir. Çalışmaya, orta riskli nüksetmiş akut lenfoblastik lösemi tanısı olan genç hastalar katılabilmiştir. Children's Oncology Group tarafından yürütülen çalışma Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

Children's Oncology Group

Müdahale

vincristine sulfate, prednisone, doxorubicin hydrochloride, pegaspargase, cytarabine, methotrexate, dexamethasone, etoposide, cyclophosphamide, leucovorin calcium, filgrastim, asparaginase, mercaptopurine

Başlangıç

01.03.2007

Ülkeler

United States, Australia, Canada, Switzerland

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Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Diagnosis of acute lymphoblastic leukemia (ALL)

  * Bone marrow with \> 25% L1 or L2 lymphoblasts (M3 marrow)

    * Patients with \> 25% L3 marrow lymphoblasts and/or evidence of c-myc translocation are not eligible (considered Burkitt's or mature B-cell leukemia)
* Intermediate-risk relapsed disease, meeting 1 of the following criteria:

  * Bone marrow relapse ≥ 36 months after initial diagnosis (defined as M3 marrow after previous remission from ALL)
  * Combined bone marrow and extramedullary (CNS\* and/or testicular\*\*) relapse ≥ 36 months after initial diagnosis
  * Isolated extramedullary (CNS\* and/or testicular\*\*) relapse \< 18 months after initial diagnosis
* The following subtypes are not allowed:

  * T-lineage ALL
  * Mature B-cell (Burkitt's) leukemia (defined as L3 morphology and/or evidence of c-myc translocation)
  * Philadelphia-chromosome positive disease
* No Down syndrome (trisomy 21)
* Shortening fraction \>= 27% by echocardiogram OR ejection fraction \>= 50% by radionuclide angiogram
* Bilirubin \< 3.0 mg/dL
* Not pregnant
* Fertile patients must use effective contraception
* No history of peripheral neuropathy \>= grade 3 within the past month
* No toxicity (i.e. peripheral neuropathy) \>= grade 3 attributable to vincristine within the past month
* At least 5 days since prior intrathecal chemotherapy
* No prior hematopoietic stem cell or marrow transplantation
* No prior cranial radiotherapy \> 1200 cGy (for patients with CNS relapse)
* No concurrent stem cell transplant
* No concurrent alternative therapy
* No concurrent itraconazole in patients receiving vincristine
* No concurrent intensity-modulated radiotherapy