JPRN-jRCTs041190043
Recruiting
Phase 2
A multicenter phase II study to evaluate a safety and efficacy of the clofarabine combination chemotherapy for infants with newly diagnosed MLL gene rearranged ALL and an exploratory study for infants with germline MLL gene ALL - MLL-17
Miyamura Takako0 sites42 target enrollmentJune 17, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Miyamura Takako
- Enrollment
- 42
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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:
- •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
Outcomes
Primary Outcomes
Not specified
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