Akut Lenfoblastik Lösemi veya Akut Lenfoblastik Lenfoması Olan Ergen/Genç Erişkinler için Güçlendirilmiş Berlin-Frankfurt-Münster (BFM) Tedavisi

Sade dilde özet

Bu çalışma, akut lenfoblastik lösemi (acute lymphoblastic leukemia) veya lenfoblastik lenfoma olan ergen ve genç erişkinlerde güçlendirilmiş BFM adlı kemoterapi rejimini inceliyor. 12-40 yaş arası, tedavisiz veya en fazla bir önceki tedavisi olan hastalar dahil edilmiştir. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

M.D. Anderson Cancer Center

Müdahale

Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Methotrexate, Doxorubicin, Thioguanine

Başlangıç

12.09.2006

Tahmini bitiş

26.07.2018

Ülkeler

United States

İlgili genler

Merkezler

• Houston, United States

Uygunluk kriterleri

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

Inclusion Criteria:

1. Patients must have precursor-B or T-lymphoblastic leukemia or lymphoblastic lymphoma.
2. Patients must be untreated or have had only one prior chemotherapy regimen for ALL or LL . Previously treated patients will be analyzed separately.
3. Age between 12 to 40 years old
4. Patients with Central Nervous System (CNS) disease or testicular disease are eligible.
5. Intrathecal therapy with cytarabine is allowed prior to registration for patient convenience. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. Systemic chemotherapy must begin within 72 hours of the first intrathecal treatment.
6. Signed informed consent prior to the start of systemic therapy. In the event of enrollment of a minor patient, an attempt to obtain assent from the patient must be documented, and parental consent must be signed.
7. Echocardiogram should be done within 72 hours of starting therapy if there are cardiac risk factors (e.g., history of hypertension or of myocardial infarction)
8. Creatinine should be \< 3 mg/dL bilirubin \< 3 mg/dl unless felt to be due to disease
9. Zubrod Performance status of \<3
10. Patients who received steroids more than 72 hours prior to study enrollment are eligible but will be analyzed separately

Exclusion Criteria:

1. Age less than twelve years of age or greater than 40 years.
2. More than one prior treatment regimen for ALL or LL.
3. The patient is pregnant or unwilling to practice appropriate birth control.
4. Presence of the Philadelphia chromosome t(9;22)