Clinical trial · Interventional
Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months)
NCT00096135CI-TRIAL-00026538completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| mercaptopurine | Drug | Mercaptopurine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CNS Patients-Treatment (combination chemotherapy)
- description
- All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.
- interventionNames
- Biological: filgrastim
- Drug: cyclophosphamide
- Drug: cytarabine
- Drug: daunorubicin hydrochloride
- Drug: dexamethasone
- Drug: etoposide
- Drug: leucovorin calcium
- Drug: mercaptopurine
- Drug: methotrexate
- Drug: pegaspargase
- Drug: therapeutic hydrocortisone
- Drug: vincristine sulfate
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Testicular Relapse Patients (Combination chemotherapy)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
- Maximum age
- 29 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of acute lymphoblastic leukemia (ALL)
* B-precursor lineage (T-precursor lineage closed to accrual as of 05/20/10)
* In first bone marrow remission (M1 by morphology) AND duration of first complete remission ≥ 18 months from time of initial diagnosis
* First isolated CNS and/or testicular relapse
* Isolated CNS relapse, as defined by 1 of the following:
* WBC ≥ 5/mm\^3 in cerebrospinal fluid (CSF) with blasts present on cytospin
* Any number of WBC in CSF with immunophenotypic proof of leukemic relapse, defined by the following:
* Identifiable blasts AND 1 of the following:
* B-lineage (TdT OR CD-10-positive on 2 consecutive CSF samples obtained 4 weeks apart)
* T-lineage (TdT AND CD-7 OR TdT positivity alone on 2 consecutive CSF samples obtained 4 weeks apart) (Closed to accrual as of 05/20/10)
* Isolated testicular relapse, defined as biopsy proven testicular involvement
* No Down syndrome
* No T-cell ALL or T-cell non-Hodgkin lymphoma
* No known optic nerve and/or retinal involvement
PATIENT CHARACTERISTICS:
Age
* 18 months to 29 years at relapse
Performance status
* Karnofsky 30-100% (for patients \> 16 years of age) OR
* Lansky 30-100% (for patients ≤ 16 years of age)
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Creatinine adjusted according to age as follows:
* No greater than 0.4 mg/dL (≤ 5 months)
* No greater than 0.5 mg/dL (6 months -11 months)
* No greater than 0.6 mg/dL (1 year-23 months)
* No greater than 0.8 mg/dL (2 years-5 years)
* No greater than 1.0 mg/dL (6 years-9 years)
* No greater than 1.2 mg/dL (10 years-12 years)
* No greater than 1.4 mg/dL (13 years and over \[female\])
* No greater than 1.5 mg/dL (13 years to 15 years \[male\])
* No greater than 1.7 mg/dL (16 years and over \[male\]) OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Cardiovascular
* Shortening fraction ≥ 27% by echocardiogram OR
* Ejection fraction ≥ 50% by MUGA
Other
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior bone marrow transplantation
Chemotherapy
* Prior total anthracycline dosage ≤ 360 mg/m\^2
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior systemic therapy for concurrent extramedullary relapseReferences
Publications (0)
Data not yet available
No reference posted for this study.