Status:
COMPLETED
Clofarabine-cyclophosphamide as Salvage Therapy for Refractory and Relapsed Acute Lymphoblastic Leukemia (ALL) Adults
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This is a multicentric, prospective pilot trial testing a Clofarabine-Cyclophosphamide combination to treat refractory and first bone marrow relapse adult ALL, for the achievement of a complete remiss...
Detailed Description
The proposed treatment schedule consists of a combination of Clofarabine plus Cyclophosphamide administered over 5 consecutive days (Treatment scheme). This is an open, nonrandomized prospective phase...
Eligibility Criteria
Inclusion
- Signed written informed consent according to IGH/EU/GCP and national local laws.
- Age 18-60 years.
- ALL with B-/T-precursor phenotype refractory to first line therapy.
- ALL with B-/T-precursor phenotype 1st isolated bone marrow relapse, occurring \< 24 months from the achievement of first CR, after chemotherapy or hematopoietic stem-cell transplantation (HSCT) defined as follows:
- \* ≥ 5% leukemic blasts in the bone marrow not attributable to another cause (e.g. marrow regeneration); if there are no circulating blasts and the bone marrow contain 5-20% leukemic blasts, a repeat bone marrow performed at least a week later is necessary to confirm relapse.
- ECOG performance status 0-2 or reversible ECOG 3 score following intensive care of complications.
- Adequate hepatic and renal function, unless considered due to organ leukemic involvement:
- Serum creatinine \<1.5 mg/dl; if serum creatinine \>1.5 mg/dl, then the estimated glomerular filtration rate (GFR) must be \> 60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female), x (1.212) if patient is black.
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN).
- Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2.5 x ULN.
- Alkaline phosphatase ≤ 2.5 x ULN.
Exclusion
- Prior exposure to Clofarabine or, in primary refractory patients only, to Cyclophosphamide during induction courses.
- Patients relapsed \> 24 months from first CR. - Philadelphia chromosome-positive (Ph+) ALL.
- Diagnosis of Burkitt-type/B-ALL, or B-/T-lymphoblastic lymphoma with \< 25% bone marrow involvement.
- Concurrent or isolated central nervous system (CNS) relapse.
- Pre-existing, uncontrolled pathology such as cardiac disease (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrythmias, NYHA classes III and IV).
- Severe neurological or psychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan.
- Active uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- HIV positive serology or active hepatitis infection. - Concurrent diagnosis of active cancer requiring concurrent chemotherapy and/or radiotherapy, and/or with life expectancy \< 1 year.
- Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of Clofarabine-Cyclophosphamide). Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drugs.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2017
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01462253
Start Date
October 1 2012
End Date
March 11 2017
Last Update
January 25 2019
Active Locations (27)
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1
Unità Operativa Ematologia 1 - Università degli Studi di Bari
Bari, Italy, 70010
2
Divisione di Ematologia - Ospedali Riuniti
Bergamo, Italy
3
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, Italy
4
Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO
Bolzano, Italy