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Allo-allo Tandem Matched Stem Cell Transplantation (AATT) for the Treatment of Patients With Refractory Acute Leukemia; a Feasibility Phase I/II Study

Phase 1/Phase 2
3 Years
50 Years
Open (Enrolling)
Refractory Acute Leukemia

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Trial Information

Allo-allo Tandem Matched Stem Cell Transplantation (AATT) for the Treatment of Patients With Refractory Acute Leukemia; a Feasibility Phase I/II Study

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. The current study is limited only for patients with refractory disease
that received and failed up to 2 lines of salvage therapy, in good performance status and
younger than 50 years old. Only patients that will achieve complete remission after
transplant I, will have no major organ dysfunction and with acceptable performance status,
will be treated with transplant II. Close monitoring with strict stopping rules including in
case of excess transplant related morality, acute or chronic GVHD or graft failure will be

Treatment schedule:

15 patients (divided into 2 cohorts, see below) with matched family member or unrelated
donor will be included in single arm open phase I/II trial.

Conditioning protocol:

All patients will be prepared by the same sequential conditioning protocols:

Transplant I: Cy-TBI followed by Transplant II: Busulfan-thiotepa.

Inclusion Criteria:

1. 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).

2. A donor willing and capable of donating peripheral blood stem cells and preferably
also bone marrow cells, and lymphocytes if indicated.

3. Each patient / patient's guardian must sign written informed consent.

4. 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 Criteria:

1. Not fulfilling any of the inclusion criteria.

2. In complete or very good partial remission.

3. Beyond 2nd relapse.

4. Received > 2 lines of salvage therapy.

5. Active CNS involvement of the leukemia

6. Active life-threatening infection.

7. Overt untreated infection.

8. HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active

9. 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).

10. Previous autologous or allogeneic stem cell transplantation.

11. Inability to comply with study requirements.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Transplant-related mortality (TRM) of SCT II.

Outcome Time Frame:


Safety Issue:



Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

November 2009

Completion Date:

November 2013

Related Keywords:

  • Refractory Acute Leukemia
  • Leukemia
  • Acute Disease