Clofarabine based remission induction followed by haploidentical stem celltransplantation in children with refractory hematological malignancies

• Conditions: Therapy resitant leukemia in children and young adults

• Registration Number: EUCTR2009-012437-30-SE
• Lead Sponsor: Skånes University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

3.1 Inclusion Criteria
I. Target population
1. Refractory acute lymphoblastic leukemia
a. Chemoresistant isolated or combined bone marrow relapse
• Relapse after during/after conventional treatment
• Relapse >6 months after allogeneic stem cell transplantation
b. Primary induction failure
c. Isolated extramedullary relapse after previous HSCT (>6
months)
2. Refractory acute myeloblastic leukemia including sAML
a. Chemoresistant relapse
• Relapse after during/after conventional treatment
• Relapse >6 months after allogeneic stem cell
transplantation[1]
b. Primary induction failure
II. Inclusion criteria to start induction treatment with multidrug regimen
1. Age > 1 and =21 years
2. Patients with previous HCST = 6 m[1]
3. Provide signed written informed consent patients’, and patients’
parents/guardians
a. Older children should be capable of understanding the
investigational nature, potential risks and benefits of the study,
and able to provide valid informed consent as well.
4. Cardiac output SF =25%
5. Have adequate renal and hepatic functions as indicated by the
following laboratory values:
• Calculated creatinine clearance =90 ml/min/1.73 m2 as
calculated by the Schwartz formula for estimated glomerular
filtration rate (GFR) where GFR (ml/min/1.73 m2) = k*Height
(cm)/serum creatinine (mg/dl). k is a proportionality constant
which varies with age and is a function of urinary creatinine
excretion per unit of body size; 0.45 up to 12 months of age;
0.55 children and adolescent girls; and 0.70 adolescent boys.
• Serum bilirubin =1.5 × upper limit of normal (ULN)
• Aspartate transaminase (AST)/alanine transaminase (ALT) =2.5 × ULN
• Alkaline phosphatase = 2.5 × ULN
6. Performance score of =70% (Lansky or Karnofsky)
7. A suitable haploidentical family member available for stem cell
donation, > 18 years of age, fulfilling institutional criteria for blood
and marrow donation.
8. Male and female patients must use an effective contraceptive
method during the study and for a minimum of 6 months after study
treatment.
III. Inclusion criteria to proceed to transplant after induction
1. Cardiac output SF =25%
2. Have adequate renal and hepatic functions as indicated by the
following laboratory values:
• Calculated creatinine clearance =90 ml/min/1.73 m2 as
calculated by the Schwartz formula for estimated glomerular
filtration rate (GFR) where GFR (ml/min/1.73 m2) = k*Height
(cm)/serum creatinine (mg/dl).
k is a proportionality constant which varies with age and is a
function of urinary creatinine excretion per unit of body size;
0.45 up to 12 months of age; 0.55 children and adolescent girls;
and 0.70 adolescent boys.
• Serum bilirubin =1.5 × upper limit of normal (ULN)
• Aspartate transaminase (AST)/alanine transaminase (ALT)
=2.5 × ULN
• Alkaline phosphatase = 2.5 × ULN
3. Performance score of =70% (Lansky or Karnofsky)
4. A suitable haploidentical family member available for stem cell
donation, > 18 years of age, fulfilling institutional criteria for blood
and marrow donation.
5. Capable of understanding the investigational nature, potential risks
and benefits of the study, and able to provide valid informed consent.
6. Female patients of childbearing potential must have a negative serum
pregnancy test within 2 weeks prior to enrolment.
7. Male and female patients must use an effective contraceptive
method during the study and for a minimum of 6 months after study
treatment.
Are the trial subjects under 18? yes
Number of subjects for this age r

Exclusion Criteria

3.2 Exclusion Criteria
1. Current concomitant chemotherapy, radiation therapy, or
immunotherapy other than as specified in the protocol.
2. Use of investigational agents within 30 days or any anticancer
therapy within 2 weeks before study entry with the exception of
hydroxyurea.
The patient must have recovered from all acute toxicities from any
previous therapy.
3. Have any other severe concurrent disease, or have a history of
serious organ dysfunction or disease involving the heart, kidney,
liver, or other organ system that may place the patient at undue risk
to undergo treatment.
4. Patients with a systemic fungal, bacterial, viral, or other infection
not controlled (defined as exhibiting ongoing signs/symptoms
related to the infection and without improvement, despite
appropriate antibiotics or other treatment).
5. Pregnant or lactating patients.
6. Any significant concurrent malignant disease, illness, or psychiatric
disorder that would compromise patient safety or compliance,
interfere with consent, study participation, follow up, or
interpretation of study results.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified