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Treatment Of Newly Diagnosed Adult Acute Lymphoblastic Leukemia With Intensified Post Remission Therapy Containing PEG-Asparaginase.


Phase 2
18 Years
55 Years
Not Enrolling
Both
Acute Lymphoblastic Leukemia

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Trial Information

Treatment Of Newly Diagnosed Adult Acute Lymphoblastic Leukemia With Intensified Post Remission Therapy Containing PEG-Asparaginase.


Inclusion Criteria:



- Patients with previously untreated ALL subtypes L1 and L2.

- Patients with de novo Philadelphia (Ph)+ ALL (i.e. excluding those that are after
blastic of CML) are eligible. However they will be referred to allogeneic
hematopoietic stem cell transplantation and will continue on the study until they are
ready to undergo the transplantation. At that time they will discontinue the study.
Patients who are unable to undergo allogeneic transplantation will continue on the
study.

- Presence of 25% or more of lymphoblasts in the bone marrow by FAB criteria,
confirmed by TdT positivity or by flow cytometry with standard ALL markers.

- Patients may have received prior steroids.

- Age: 18 - 55 years

- Signed Informed Consent

Exclusion Criteria:

- Patients with Burkitt's ALL (L3 subtype) or CML lymphoblastic crisis are not eligible
(including CML patients who present with ALL blastic crisis).

- Psychological or emotional disorders which will make a valid informed consent
impossible.

- Bilirubin >1.5 mg/dl, creatinine > 2.5 mg/dl

- Symptomatic congestive heart failure or unstable angina

- Pregnant or lactating females

- Known HIV positive status

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assessment of pt developing anti-asparaginase antibody

Outcome Time Frame:

assessed 3 times

Safety Issue:

Yes

Principal Investigator

Dan Douer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Food and Drug Administration

Study ID:

9L-03-1

NCT ID:

NCT00184041

Start Date:

July 2004

Completion Date:

December 2012

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804