Status:
UNKNOWN
Allo-Allo Tandem Bone Marrow Transplant (BMT)
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Refractory Acute Leukemia
Eligibility:
All Genders
3-50 years
Phase:
PHASE1
PHASE2
Brief Summary
Refractory acute leukemia (AL) occurs in a significant percentage of the AL patients and presents a therapeutic challenge. Allogeneic stem cell transplantation (allo-SCT) is the only curative option f...
Detailed Description
The effects of feasibility oExperimental design and methods f allo-allo tandem matched stem cell transplantation (AATT) in patients with refractory leukemia will be evaluated in a clinical setting. Th...
Eligibility Criteria
Inclusion
- Patient age 3-50 years old with refractory acute leukemia (primary refractory or refractory relapse I or II) unresponsive to up to 2 salvage lines with a matched donor (related or unrelated, matched defined as 8/8 HLA matching).
- A donor willing and capable of donating peripheral blood stem cells and preferably also bone marrow cells, and lymphocytes if indicated.
- Each patient / patient's guardian must sign written informed consent.
- Patients must have an ECOG PS ≤ 1; Creatinine \<1.5 mg/dl; Ejection fraction \>45%; DLCO \>70% of predicted; Serum bilirubin \<2 mg/dl; elevated GPT or GOT \< 2 x normal values before transplant I.
Exclusion
- Not fulfilling any of the inclusion criteria.
- In complete or very good partial remission.
- Beyond 2nd relapse.
- Received \> 2 lines of salvage therapy.
- Active CNS involvement of the leukemia
- Active life-threatening infection.
- Overt untreated infection.
- HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
- Donor contraindication (HIV seropositive confirmed by Western Blot, Hepatitis B antigenemia, HCV, evidence of bone marrow disease, unable to donate bone marrow or peripheral blood due to concurrent medical condition).
- Previous autologous or allogeneic stem cell transplantation.
- Inability to comply with study requirements.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00984412
Start Date
November 1 2009
End Date
November 1 2020
Last Update
February 19 2016
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel