At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of B-precursor lineage ALL
- ✓First complete remission duration ≥18 months from initial diagnosis
- ✓First isolated CNS relapse (WBC ≥5/mm³ in CSF with blasts, or any WBC with immunophenotypic proof of leukemic relapse)
- ✓First isolated testicular relapse with biopsy confirmation
- ✕Down syndrome
- ✕T-cell ALL or T-cell non-Hodgkin lymphoma
- ✕Known optic nerve and/or retinal involvement
- ✕Prior bone marrow transplantation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months)
In Brief
A clinical study evaluating filgrastim, cyclophosphamide, and 11 other interventions for Leukemia. Completed, enrolled 168 participants across 153 sites in 5 countries.
Detailed Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells. PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the CNS and/or testes.
Study Details
Timeline
Interventions
given subcutaneously (SC)
IV over 15-30 minutes
IV over 3 hours twice daily
IV over 15 minutes
oral twice daily
IV over 1 hour
rescue IV over 24 hours
oral
intramuscularly (IM)
intramuscularly (IM)
given IV
Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation. Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.