Know Cancer

or
forgot password

Prospective Multicenter Phase II Study for the Treatment of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.


Phase 2
15 Years
60 Years
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

Prospective Multicenter Phase II Study for the Treatment of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Description:

Evaluation of disease free survival in patients with high risk of remission obtaining a Complete Remission as from the date of hematological complete remission.

Outcome Time Frame:

At 4 years from study entry

Safety Issue:

No

Principal Investigator

Roberto Foa, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Universita Degli Studi "La Sapeinza"

Authority:

Italy: Ethics Committee

Study ID:

LAL0904

NCT ID:

NCT00458848

Start Date:

October 2004

Completion Date:

Related Keywords:

  • Leukemia
  • 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
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Neoplasm, Residual

Name

Location