Phase 2
N=29
Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Leukemia · Lymphoma · Small Intestine Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00416351 ↗Enrolled (actual)
29
Serious AEs
65.5%
Results posted
May 2022
Primary outcome: Primary: Maximum Tolerated Dose — 20 mg/m2 of clofarabine
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- clofarabine (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose |
20 | — |
| PRIMARY Response Rate for Participants With Non-Hodgkin's Lymphoma |
0; 1; 1; 1; 0; 0 | — |
| SECONDARY Participants Evaluated for Toxicity |
1; 3; 4; 17; 4 | — |
Summary
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.
PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works in treating patients with T-cell or natural killer-cell lymphoma that has relapsed or not responded to previous treatment.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed T-cell or natural killer (NK)-cell lymphoma, including any of the following subtypes:
- Blastic NK-cell lymphoma
- T/NK-cell lymphoma/leukemia
- Adult T-cell lymphoma/leukemia
- T-cell prolymphocytic leukemia
- T-lymphoblastic lymphoma
- Peripheral T-cell lymphoma, not otherwise specified
- Angioimmunoblastic T-cell lymphoma
- Anaplastic large cell lymphoma
- Transformed mycosis fungoides
- Subcutaneous panniculitis-like T-cell lymphoma
- Nasal T/NK-cell lymphoma
- Enteropathy-type T-cell lymphoma
- Hepatosplenic gamma/delta T-cell lymphoma
- Relapsed or refractory disease, meeting both of the following criteria:
- Must have been treated with prior cytotoxic chemotherapy and/or monoclonal antibody therapy
- No standard curative treatment exists
- Allogeneic bone marrow transplantation is not considered standard curative treatment
- Evaluable disease (Phase I)
- Measurable disease, defined as any nodal site or mass lesion ≥ 1.5 cm in longest transverse diameter on physical exam or CT scan OR a measurable extranodal site > 1 cm (Phase II)
- Patients with evaluable blood- or marrow-based disease are eligible
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1, 500/mm³ (Phase I)
- Absolute neutrophil count ≥ 500/mm³ (Phase II)
- Platelet count ≥ 100,000/mm³ (Phase I)
- Platelet count ≥ 50,000/mm³ (Phase II)
- Creatinine < 2.0 mg/dL*
- Bilirubin ≤ 2.0 times upper limit of normal (ULN)*
- AST and ALT ≤ 2.5 times ULN*
- No active infection requiring antibiotics
- No New York Heart Association class III or IV congestive heart failure
- No known HIV positivity
- No other active malignancy requiring therapy
- No other serious or life-threatening condition deemed unacceptable by the principal investigator
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception NOTE: *Unless due to lymphoma and patients are entering to the phase II portion of the study
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks since prior therapy, including any of the following:
- Interferon
- Antibody therapy
- Retinoids
- Other non-chemotherapeutic treatment
- Concurrent stable-dose corticosteroids allowed
- No colony-stimulating factor therapy during the first course of study therapy
Data sourced from ClinicalTrials.gov (NCT00416351). 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.