Clinical trial · Interventional
Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
A Phase II Study of Gemcitabine (NSC #613327) in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
NCT00006462CI-TRIAL-00013810completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Relapsed acute lymphoblastic and acute Myelogenous leukemia
- description
- Gemcitabine hydrochloride will be given as 10 mg/m2/min x 360 minutes weekly for three weeks. After a one-week rest period it may be repeated in patients without progressive disease or limiting toxicity.
- interventionNames
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- Determine the response rate to Gemcitabine
- description
- To determine the response rate to Gemcitabine administered as 10 mg/m2/min x 360 minutes weekly for 3 weeks in patients with relapsed acute lymphoblastic and acute myelogenous leukemia.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of relapsed acute lymphoblastic leukemia or acute myelogenous leukemia * M3 marrow (at least 25% blasts in bone marrow aspirate) * Refractory to conventional therapy PATIENT CHARACTERISTICS: Age: * 21 and under at diagnosis Performance status: * ECOG 0-2 OR * Zubrod 0-2 Life expectancy: * At least 2 months Hematopoietic: * Not specified Hepatic: * Bilirubin normal * SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: * Creatinine normal OR * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunomodulating agents Chemotherapy: * 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 Radiotherapy: * Concurrent radiotherapy to localized painful lesions allowed Surgery: * Not specified Other: * Recovered from any prior therapy
References
Publications (1)
- RESULTAngiolillo AL, Whitlock J, Chen Z, Krailo M, Reaman G; Children's Oncology Group. Phase II study of gemcitabine in children with relapsed acute lymphoblastic leukemia or acute myelogenous leukemia (ADVL0022): a Children's Oncology Group Report. Pediatr Blood Cancer. 2006 Feb;46(2):193-7. doi: 10.1002/pbc.20419. PMID 15929131