Phase 2
N=30
Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma
Follicular Lymphoma · Marginal Zone Lymphoma · Mantle Cell Lymphoma · Small Lymphocytic Lymphoma · Lymphoplasmacytic Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00644189 ↗Enrolled (actual)
30
Serious AEs
30.0%
Results posted
May 2017
Primary outcome: Primary: All Phase I-II Participants: Overall Response Rate (ORR) — 28 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Clofarabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Phase I-II Participants: Overall Response Rate (ORR) |
28 | — |
| PRIMARY Phase I Participants Only: Overall Response Rate (ORR) |
47 | — |
| SECONDARY Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR) |
28 | — |
| SECONDARY All Phase I-II Participants: Progression-free Survival (PFS) |
32; 16 | — |
| SECONDARY All Phase I-II Participants: Overall Survival (OS) |
58 | — |
| SECONDARY All Phase I-II Participants: Safety |
29; 24; 15; 7; 3 | — |
| SECONDARY Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR) |
5; 4; 7 | — |
| SECONDARY Phase I Participants: Progression-free Survival (PFS) |
34 | — |
| SECONDARY All Phase I Participants: Overall Survival (OS) |
75 | — |
| SECONDARY Phase I Participants: Safety |
19; 18; 9; 8; 1; 3 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00644189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.