N/A N=168 Treatment

Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes

Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00096135 ↗

Enrolled (actual)

168

Serious AEs

4.8%

Results posted

Aug 2015

Primary outcome: Primary: Event-free Survival — 64.9; 70 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: filgrastim (Biological); 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 (Drug); radiation therapy (Radiation)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: Children's Oncology Group
Primary completion: Sep 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Event-free Survival	64.9; 70	—

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.

Eligibility Criteria

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 relapse

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00096135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.