Clinical trial · Interventional
Gemcitabine and Bexarotene in Treating Patients With Progressive or Refractory Stage IB, Stage II, Stage III, or Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
A Phase II Study of Gemcitabine and Bexarotene (Gembex) in the Treatment of Cutaneous T-cell Lymphoma
NCT00660231CI-TRIAL-00016212GemBexcompletedPhase 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, such as gemcitabine and bexarotene, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying giving gemcitabine together with bexarotene to see how well it works in treating patients with progressive or refractory stage IB, stage II, stage III, or stage IV cutaneous T-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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bexarotene | Drug | Bexarotene | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GemBex
- description
- Gemcitabine days 1 and 8 of a 3 week cycle (4 cycles total - 12 weeks) Bexarotene daily: in combination with Gemcitabine during first 12 weeks, then Bexarotene maintenance until disease progression.
- interventionNames
- Drug: bexarotene
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- Rate of objective response
- timeFrame
- at 24 weeks
Secondary outcomes (2)
- measure
- Duration and durability of objective disease response
- timeFrame
- up to 5 years after treatment start
- description
- Time from first date of treatment to the first date of diagnosis of progressive disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed cutaneous T-cell lymphoma (CTCL) including its variants (e.g., mycosis fungoides and Sézary syndrome)
* CTCL stage IB, IIA, IIB, III or IVA disease
* No visceral involvement (i.e., stage IVB disease)
* Lymphadenopathy is allowed
* Patients must have developed progressive disease after receiving or have been refractory to at least 1 course of prior standard, systemic, skin-directed therapy (e.g., interferon, chemotherapy, or denileukin diftitox \[Ontak®\])
* No CD30 + (Ki1+ve) anaplastic large cell lymphoma
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy \> 6 months
* Hemoglobin ≥ 9.0 g/dL (transfusions and/or erythropoietin are allowed)
* ANC \> 1.5 x 10\^9/L
* Platelet count ≥ 100 x 10\^9/L
* Total bilirubin ≤ 1.25 times upper limit of normal (ULN)
* AST and ALT ≤ 2 times ULN
* Serum creatinine ≤ 2 times ULN
* No clinically significant active infection
* No uncontrolled diabetes mellitus
* No excessive alcohol consumption
* No biliary tract disease
* No history of pancreatitis
* HIV negative
* Hepatitis B and C negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 month after study participation
* No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer, cervical epithelial neoplasm CIN1, or carcinoma in situ
* No other significant medical or psychiatric condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 4 weeks since any prior investigational agent
* More than 2 weeks since prior topical steroids or more than 4 weeks since prior systemic steroids
* Local radiotherapy may be given to isolated symptomatic tumour nodules that require immediate treatment for up to 2 weeks prior to study drugs
* No prior treatment with bexarotene (Targretin®)
* No concurrent anticancer therapy
* No concurrent investigational agent
* No concurrent drug therapy with other medications that can elevate triglycerides or cause pancreatic toxicity (e.g., gemfibrozil)
* No concurrent warfarinReferences
Publications (0)
Data not yet available
No reference posted for this study.