A study of clofarabine combination therapy for infant A
- Conditions
- Infant acute lymphoblastic leukemia
- Registration Number
- JPRN-jRCTs041190043
- Lead Sponsor
- Miyamura Takako
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 42
A patient must meet all of the following criteria in order to be eligible to participate in MLL-17 study:
(1) Infants less than 365 days of age at time of diagnosis of acute lymphoblastic leukemia (ALL)
(2) Patients with newly diagnosed ALL.
(3) A written informed consent of CHM-14 must be obtained prior to the registration of MLL-17.
(4) A written informed consent of MLL-17 registration must be obtained from the parents or guardians.
A patient who meets any of the following criteria will be excluded from participation in MLL-17 study:
(1) If patients are diagnosed at < 30 days of age, patients gestational age is less than 36 weeks and 0 days.
(2) If patients meet any of the following diagnostic criteria:
a. T-ALL
b. Presence of t(9;22) (q34;q11) or BCR-ABL fusion transcript,
c. Presence of t(8;14)(q24;q32), t(2;8)(p13;q24), t(8;22)(q24;q11) or specific fusion transcript associated with mature B-ALL
d.Down syndrome associated ALL
* Mixed phenotype acute leukemia (MPAL), and acute leukemia of ambiguous lineage (AUL) will be included in this clinical trial.
However, the following cases are excluded.
a. Cases in which the myeloblast ratio is higher than that of the lymphoblast
b. Cases which meet the criteria with T-ALL
c. Cases which meet the criteria with lymphoid antigen- positive AML
(3) Patients who evaluated as ECOG Performance status (PS) score 4 which modified for infants.
(4) Patients with unacceptable severe organ failure.
a. Patients with uncontrollable severe cardiac failure
b. Patients with uncontrollable severe renal failure
c. Patients with respiratory failure who require mechanical ventilation
d. Patients with unacceptable severe central nerve system hemorrhage
(5) Patients with uncontrollable severe infection.
(6) Patients with severe congenital disease or unacceptable complications.
(7) Patients with multiple primary cancer.
(8) Patients who received different chemotherapy or radiation therapy before registration.
(9) Patients who evaluated ineligible by principal physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3 year event free survival (EFS) rate of MLL rearranged infant A
- Secondary Outcome Measures
Name Time Method