Main info

Identifier:

HO100 ALL

Sponsor:

HOVON

Working group party:

Leukemia

Age:

18-70

Stage:

2nd Line

Echelon:

Level C-HIC

Included patients:

376

(of 376)

Active sites:

31

(of 32)

Title:

Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults. A prospective randomized trial.

Timeline

News

Flow

Details

Phase:

Prospective Phase II/III study

Monitoring Type:

Not any more

Objectives:

Phase II part

• To determine the feasibility of adding i.v. clofarabine to standard prephase therapy (followed by induction chemotherapy)

Phase III part
Primary objective:

• To improve EFS in adult ALL patients by the addition of i.v. clofarabine to prephase and consolidation therapy

Secondary objectives:

• To improve the molecular response rate of adult ALL following RI by the addition of i.v. clofarabine to standard prephase and consolidation therapy
• To improve DFS, and OS in adult ALL patients by the addition of i.v. clofarabine to the standard prephase and consolidation therapy
• To document safety and toxicity of adding clofarabine to standard prephase and consolidation therapy in adult ALL
• To assess and compare clinical outcome of patients with and without an HLA-identical sibling in a donor vs no-donor analysis
• To determine the incidence and clinical relevance of thromboembolic (TE) complications during adult ALL treatment with LMWH as antithrombotic prophylaxis
• To determine the influence of ALL (treatment) on different coagulation markers

Eligibility

Inclusion Criteria:

• Patients aged 18 to 70 years inclusive
• Primary previously untreated B or T-lineage ALL (excluding ALL with mature B-cell phenotype, but including Philadelphia positive or BCR-ABL positive ALL) or previously untreated T-LBL (pretreatment with prednisolone for 7 days is allowed)
• WHO performance status 0 – 2
• Adequate renal and hepatic function tests as indicated by the following laboratory values:
  • Serum creatinine ≤1.0 mg/dl (≤ 88.7 micromol/L); if serum creatinine >1.0 mg/dl (>88.7 micromol/L), then the glomerular filtration rate (GFR) must be >60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where the predicted GFR

(ml/min/1.73 m2) = 186 x (Serum Creatinine in mg/dl)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if patient is black)
NOTE: if serum creatinine is measured in micromol/L, recalculate it in mg/dl according tobthe equation: 1 mg/dl = 88.7 micromol/L) and used above mentioned formula.

• Serum bilirubin ≤ 1.5 × upper limit of normal (ULN)
  • Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2.5 × ULN
  • Alkaline phosphatase ≤ 2.5 × ULN
• Negative pregnancy test at inclusion, if applicable
• Written informed consent

Exclusion Criteria:

• Mature surface Ig positive B-cell leukemia/lymphoma
• Acute undifferentiated leukemia
• Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
• Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D)
• Severe neurological or psychiatric disease
• History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
• Active, uncontrolled infection
• Patient known to be HIV-positive
• Patient is a lactating woman
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Unwilling or not capable to use effective means of birth control (all men, all premenopausal women under the age of 50 need contraception for two years after the last period, and women older than 50 yrs for at least one year)

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals