Early intensification by (un)related allogeneic or autologous stem cell transplantation in adult acute lymphoblastic leukemia. A phase II study.

Study phase:

phase 2.



Study objectives:

1. To study prospectively the value of early intensification by allogeneic or autologous stem cell transplantation in ALL;

2. To study prospectively stem cell transplantation with a matched unrelated donor in high-risk ALL when no sibling donor is available;

3. To study the value of donor lymphocyte infusion (DLI) in high-risk ALL with a molecular or cytogenetic relapse after allogeneic stem cell transplantation or in high-risk ALL with persistent residual disease (molecular; cytogenetic);

4. To study the value of maintenance chemotherapy in ALL patients after autologous transplantation;

5. To study leukemic cell reduction by means of (semi-quantitative) molecular techniques during induction chemotherapy, after consolidation with stem cell transplantation, and during maintenance chemotherapy in patients receiving an autologous stem cell transplantation.




Patient population:

Patients with previously untreated, B-precursor ALL, T-ALL or AUL, age 16-59 years inclusive.




Study design:

Prospective, multicenter, randomized.

Patients who are in 1st CR after autologous transplantation, may be randomized between no further treatment (arm A) and maintenance chemotherapy (arm B). The hypothesis to be tested is that maintenance therapy will prolong disease free survival, calculated from the date of randomization.

N/A

All patients will receive early intensification:

- cycle 1: prednisone, vincristine, daunorubicin, aspariganse, MTX i.t.

- cycle 2: Cytarabine, Mitoxantrone, MTX i.t.

- cycle 3: Methotrexate, asparaginase, 6-MP, MTX i.t.


After intensification patients will receive either an allogeneic sibling stem cell transplantation, a matched unrelated donor stem cell transplantation or an autologous stem cell transplantation.


Patients who received an autologous stem cell transplantation will be randomized between:

- Arm A: no further treatment.

- Arm B: maintenance treatment with 6-MP and MTX.