Clinical trial · Interventional
Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma
A Phase II Study of Oral Clofarabine in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma
- 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)
Oral clofarabine is related to two intravenous chemotherapy drugs used for this disease and works in two different ways. It affects the development of new cancer cells by blocking two enzymes that cancer cells need to reproduce. When these enzymes are blocked, the cancer call can no longer prepare the DNA needed to make new cells. Clofarabine also encourages existing cancer cells to die by disturbing components within the cancer cell. This causes the release of a substance that is fatal to the cell. This trial studies the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin lymphomas.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Large-cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Angioimmunoblastic T-cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Low Grade B-cell Lymphoma, Not Otherwise Specified | — | UNRESOLVED | — |
| Lymphoplasmacytic Lymphoma | Lymphoplasmacytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine | Drug | Clofarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Clofarabine
- description
- Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
- interventionNames
- Drug: Clofarabine
Primary outcomes (2)
- measure
- All Phase I-II Participants: Overall Response Rate (ORR)
- timeFrame
- after at most 6 28-day cycles
- description
- Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I-II trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- measure
- Phase I Participants Only: Overall Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed relapsed or refractory NHL that includes: follicular lymphoma of any grade; marginal zone lymphoma; small lymphocytic lymphoma/chronic lymphocytic leukemia; mantle cell lymphoma; lymphoplasmacytic lymphoma; low-grade B-cell lymphoma not otherwise specified; diffuse large B-cell lymphoma, anaplastic large cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma. * One or more prior line of chemotherapy, immunotherapy, or radioimmunotherapy. * Measurable disease on cross sectional imaging of at least 2cm. * ECOG Performance Status 0-2 * 18 years of age or older * Life expectancy of greater than 3 months * Normal organ and marrow function as outlined in the protocol * Must agree to use adequate contraception prior to study entry and for the duration of study participation Exclusion Criteria: * Patients who have had chemotherapy, rituximab, or radiotherapy within 4 weeks, or radioimmunotherapy within 8 weeks prior to entering the study * Receiving any other investigational agent * Known brain metastases * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Clofarabine * Systemic fungal, bacterial, viral, or other infection not controlled * Pregnant or lactating * Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for over one year * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Prior allogeneic stem cell transplantation
References
Publications (0)
Data not yet available