Clinical trial · Interventional
Clofarabine and Rituximab in Treating Patients With Relapsed Non-Hodgkin Lymphoma
Phase I/II Study of Oral Clofarabine + Rituximab in Relapsed B Cell NHL
NCT00691652CI-TRIAL-00041972terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding ended when only one subject enrolled and subject withdrew early.
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving clofarabine together with rituximab may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when given together with rituximab and to see how well they work in treating patients with relapsed B-cell non-Hodgkin lymphoma.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clofarabine | Drug | Clofarabine | ALIAS |
| DNA methylation analysis | Genetic | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| high performance liquid chromatography | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| microarray analysis | Genetic | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Clofarabine + Rituximab in Relapsed B Cell NHL
- description
- Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off). Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg Phase II: Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV
- interventionNames
- Biological: rituximab
- Drug: clofarabine
- Genetic: DNA methylation analysis
- Genetic: gene expression analysis
- Genetic: microarray analysis
- Genetic: polymerase chain reaction
- Other: high performance liquid chromatography
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- The Maximum Tolerated Dose (MTD) of Oral Clofarabine in Adult Patients With Relapsed CD20+ Non-Hodgkin Lymphoma(NHL)
- timeFrame
- 14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed B-cell lymphoma * Relapsed disease * CD20-positive disease * Must have had bone marrow aspiration and biopsy (uni- or bilateral) within the past 42 days and chest CT and CT of the abdomen and pelvis within the past 28 days * Documented bidimensionally measurable disease within the past 28 days * Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group(ECOG) performance status 0-2 * Leukocyte count ≥ 3,000/μL * Absolute neutrophil count ≥ 1,500/μL * Platelet count ≥ 75,000/μL * Total bilirubin ≤ 2 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 30 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy * No known AIDS or HIV-associated complex * No active hepatitis B infection * No other severe concurrent disease, history of serious organ dysfunction, or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment * No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment * No history of intolerance or allergic reactions to clofarabine or rituximab * No significant concurrent disease, illness, or psychiatric disorder that would compromise the patient's safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results * No concurrent active GI disease that may impair absorption of oral clofarabine PRIOR CONCURRENT THERAPY: * Recovered from all previous therapies * No prior gastrointestinal (GI) surgery that may impair absorption of oral clofarabine * More than 2 weeks since prior and no concurrent anticancer therapy, except for hydroxyurea * More than 4 weeks since prior radioimmunotherapy * More than 1 month since prior investigational agents * No concurrent cytotoxic therapy or investigational therapy * No other concurrent investigational or commercial agents or therapies administered with the intent to treat the patient's malignancy * No concurrent alternative medications (e.g., herbal or botanical for anticancer purposes) * No other concurrent chemotherapy or immunotherapy * No concurrent radiotherapy * No concurrent colony stimulating factors (phase I portion of the study)
References
Publications (0)
Data not yet available
No reference posted for this study.