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A Phase II Study of Gemcitabine (NSC #613327) in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

Phase 2
21 Years
Open (Enrolling)

Thank you

Trial Information

A Phase II Study of Gemcitabine (NSC #613327) in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia


- Determine the response rate in children with relapsed or refractory acute lymphoblastic
leukemia or acute myelogenous leukemia treated with gemcitabine.

- Assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease histology
(acute lymphoblastic leukemia vs acute myelogenous leukemia).

Patients receive gemcitabine IV over 6 hours weekly for 3 weeks. Treatment repeats every 4
weeks for a maximum of 2 courses in the absence of disease progression or unacceptable

PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of relapsed acute lymphoblastic leukemia or acute myelogenous leukemia

- M3 marrow (at least 25% blasts in bone marrow aspirate)

- Refractory to conventional therapy



- 21 and under at diagnosis

Performance status:

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy:

- At least 2 months


- Not specified


- Bilirubin normal

- SGOT or SGPT no greater than 2.5 times upper limit of normal


- Creatinine normal OR

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- No concurrent immunomodulating agents


- At least 2 weeks since prior chemotherapy

- No other concurrent chemotherapy for cancer

Endocrine therapy:

- No concurrent corticosteroids except for treatment of adrenal crises with suppressed
pituitary/adrenal response

- Concurrent low-dose hydrocortisone (less than 100 mg/m2) allowed for allergic
reactions to amphotericin or transfusions


- Concurrent radiotherapy to localized painful lesions allowed


- Not specified


- Recovered from any prior therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Anne Angiolillo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Research Institute


United States: Federal Government

Study ID:




Start Date:

April 2001

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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