Clinical trial · Interventional
Gemcitabine in Treating Patients With Newly Diagnosed, Relapsed, or Chemotherapy-Resistant Mantle Cell Lymphoma
Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Gemcitabine for the Treatment of Patients With Newly Diagnosed, Relapsed or Chemotherapy Resistant Mantle Cell Lymphoma
NCT00234026CI-TRIAL-00007058completedPhase 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, 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 II trial is studying how well gemcitabine works in treating patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response at end of study treatment
Secondary outcomes (4)
- measure
- Adverse reactions at end of study treatment
- measure
- Time to progression
- measure
- Response duration
- measure
- Time to treatment failure at end of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed mantle cell lymphoma meeting 1 of the following criteria: * Newly diagnosed * Chemotherapy resistant * Relapsed disease after no more than 2 prior lines of chemotherapy * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 11 mm by CT scan * No prior or current CNS lymphoma or lymphomatous meningosis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Neutrophil count ≥ 1,500/mm\^3 (1,000/mm\^3 in case of bone marrow infiltration) * Platelet count ≥ 100,000/mm\^3 (75,000/mm\^3 in case of bone marrow infiltration) Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2 times ULN * AST and ALT ≤ 2 times ULN * No active hepatitis Renal * Creatinine clearance ≥ 50 mL/min Cardiovascular * No congestive heart failure * No New York Heart Association class III or IV heart disease * No unstable angina pectoris * No significant cardiac arrhythmia or arrhythmia requiring chronic treatment * No myocardial infarction within the past 3 months Immunologic * No active autoimmune disease * No ongoing infection (e.g., HIV) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 months after study participation * No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix * No uncontrolled diabetes mellitus * No gastric ulcers * No other uncontrolled medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent thalidomide Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Prior radiotherapy allowed provided indicator lesions were not in the irradiated field * No concurrent radiotherapy to the lungs or mediastinum Surgery * Not specified Other * More than 30 days since prior systemic anticancer treatment * More than 30 days since prior clinical trial participation * No other concurrent anticancer drugs * No other concurrent experimental drugs
References
Publications (1)
- RESULTHitz F, Martinelli G, Zucca E, von Moos R, Mingrone W, Simcock M, Peterson J, Cogliatti SB, Bertoni F, Zimmermann DR, Ghielmini M; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland. A multicentre phase II trial of gemcitabine for the treatment of patients with newly diagnosed, relapsed or chemotherapy resistant mantle cell lymphoma: SAKK 36/03. Hematol Oncol. 2009 Sep;27(3):154-9. doi: 10.1002/hon.891. PMID 19274614