Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma
A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies
NCT00047021CI-TRIAL-00003537completedPhase 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 cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and mitoxantrone in treating patients who have recurrent or refractory leukemia or lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event free survival at day 14 (myeloid engraftment)
- timeFrame
- day 14
Secondary outcomes (1)
- measure
- Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment
- timeFrame
- followed for 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 55 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* One of the following must be present:
* Histologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia
* More than 5% blasts in the bone marrow or peripheral blood unrelated to recovery of normal hematopoiesis from prior chemotherapy
* Failed at least 1 attempt at induction chemotherapy
* Diagnosis of non-Hodgkin's lymphoma or Hodgkin's lymphoma
* Refractory or relapsed after at least 1 regimen of standard chemotherapy
* Diagnosis of chronic myelogenous leukemia in accelerated phase or blast crisis
* Received at least 1 myelotoxic chemotherapy regimen
* Active CNS involvement allowed
PATIENT CHARACTERISTICS:
Age
* 55 and under
Performance status
* ECOG 0-2
Life expectancy
* At least 5 weeks
Hematopoietic
* Lymphoma patients:
* WBC at least 2,000/mm\^3\*
* Platelet count at least 20,000/mm\^3\* NOTE: \*Unless due to bone marrow involvement or disease process
Hepatic
* Bilirubin no greater than 3 times normal\*
* AST/ALT no greater than 3 times normal\*
* Alkaline phosphatase no greater than 3 times normal\*
* No severe liver failure NOTE: \*Unless related to leukemia
Renal
* Creatinine clearance greater than 50 mL/min
* No severe renal failure
Cardiovascular
* LVEF at least 45% by MUGA
Pulmonary
* DLCO at least 60% of predicted
Other
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No psychiatric illness that would preclude informed consent
* No medical illness or other condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 24 hours since prior hydroxyurea
* At least 1 week since other prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* Recovered from prior therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.