Leukemia
Conditions
Keywords
B-cell adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, L1 adult acute lymphoblastic leukemia, L2 adult acute lymphoblastic leukemia, TdT positive adult acute lymphoblastic leukemia
Brief summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia. Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.
Interventions
DRUGasparaginase
DRUGdaunorubicin hydrochloride
DRUGetoposide
DRUGidarubicin
DRUGimatinib mesylate
DRUGmercaptopurine
DRUGmethotrexate
DRUGmethylprednisolone
DRUGmitoxantrone hydrochloride
DRUGprednisone
DRUGvincristine sulfate
PROCEDUREallogeneic hematopoietic stem cell transplantation
PROCEDUREautologous hematopoietic stem cell transplantation
PROCEDUREperipheral blood stem cell transplantation
RADIATIONradiation therapy
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria: * Negative myeloperoxidase stain * Phenotype T (T-ALL) or B (B-ALL) * No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl transferase-negative) PATIENT CHARACTERISTICS: * Creatinine ≤ 2.5 mg/dL (after adequate hydration) * SGOT and SGPT ≤ 3 times upper limit of normal * LVEF ≥ 50% * No severe psychiatric disorders * No other concurrent malignant disease * No presence of documented infections not responding to antibiotic and/or antifungal therapy * Not pregnant PRIOR CONCURRENT THERAPY: * No prior steroids * No prior antiblastic chemotherapy * No other concurrent chemotherapy or radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Reaching Disease Free Survival | At 60 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Reaching Complete Hematological Response After Induction Therapy | At the end of induction, day +50 | — |
| Percentage of Participants Reaching Overall Survival | At 60 months | Overall survival from diagnosis |
Countries
Italy
Participant flow
Pre-assignment details
We are reporting on the subset of patients that was treated according to amendment three, in which Imatinib was given only at induction.
Participants by arm
| Arm | Count |
|---|---|
| Philadelphia Positive, Imatinib Only in Induction Therapy In this protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant.
Thus, we have analyzed only this subset of patients as it was not feasible to analyzed all patients enrolled due also to the disease itself. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Philadelphia Positive, Imatinib Only in Induction Therapy | — |
|---|---|---|
| Age, Continuous | 45.94 years | — |
| BCR transcript-molecular at diagnosis p190 | 39 participants | — |
| BCR transcript-molecular at diagnosis p190/p210 | 5 participants | — |
| BCR transcript-molecular at diagnosis p210 | 7 participants | — |
| Pre-treatment response Frequency missing | 3 participants | — |
| Pre-treatment response Non responder-blasts reduction <75% | 10 participants | — |
| Pre-treatment response Responder-blasts reduction >=75% | 38 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Italy | 51 participants | — |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 23 Participants | — |
| White Blood Cells (WBC) at diagnosis-nsr | 28.00 10^9 cells/L | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 51 |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 7 / 51 |
Outcome results
Primary
Percentage of Participants Reaching Disease Free Survival
Time frame: At 60 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Philadelphia Positive, Imatinib Only in Induction Therapy | Percentage of Participants Reaching Disease Free Survival | 45.8 percentage of participants |
Secondary
Number of Patients Reaching Complete Hematological Response After Induction Therapy
Time frame: At the end of induction, day +50
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Philadelphia Positive, Imatinib Only in Induction Therapy | Number of Patients Reaching Complete Hematological Response After Induction Therapy | 49 participants |
Secondary
Percentage of Participants Reaching Overall Survival
Overall survival from diagnosis
Time frame: At 60 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Philadelphia Positive, Imatinib Only in Induction Therapy | Percentage of Participants Reaching Overall Survival | 48.8 percentage of patients |