NCT01307592

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, oxaliplatin, and , work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Giving rituximab and chemotherapy together with lenalidomide may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab, gemcitabine hydrochloride, and oxaliplatin together with lenalidomide works in treating patients with relapsed or refractory, aggressive non-Hodgkin lymphoma.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Last Updated

January 10, 2014

Status Verified

February 1, 2011

Enrollment Period

2 years

First QC Date

March 1, 2011

Last Update Submit

January 9, 2014

Conditions

Lymphoma

Keywords

peripheral T-cell lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

  • Rate of conversion to complete response (CR) after switching to lenalidomide

Secondary Outcomes (4)

  • Overall survival

  • Progression-free survival

  • Safety of this regimen combination

  • Rate of conversion to partial response and CR of non-responders treated with lenalidomide

Interventions

rituximabBIOLOGICAL
gemcitabine hydrochlorideDRUG
lenalidomideDRUG
oxaliplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed aggressive non-Hodgkin lymphoma, including any of the following subtypes: * Follicular large cell lymphoma * Diffuse large cell lymphoma * Peripheral T-cell lymphoma * Transformed lymphoma * Lymphoblastic lymphoma * Burkitt or Burkitt-like lymphoma * Refractory or relapsed disease meeting the following criteria: * Patients who either did not respond to prior therapy or whose best response was partial response after ≥ 4 courses of chemotherapy * Histologic confirmation of relapsed or refractory disease is desirable but not mandatory and will be left to the discretion of the investigator * Must have evaluable or measurable disease * Patients who are candidates for stem cell or bone marrow transplantation allowed * No CNS involvement by lymphoma PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Absolute neutrophil count ≥ 1,000/mm³ (unless due to marrow infiltration by lymphoma) * Platelet count ≥ 100,000/mm³ (unless thrombocytopenia is due to marrow infiltration by lymphoma) * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless liver is involved with lymphoma, hemolysis, or Gilbert syndrome) * Serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥ 30 ml/min (unless creatinine elevation is due to lymphoma) * ALT ≤ 2 times ULN (≤ 5 times ULN if liver metastasis is involved with lymphoma) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception for ≥ 28 days before, during, and for ≥ 28 days after completion of study therapy * Men must use latex condoms even after a successful vasectomy * Must be enrolled in the mandatory RevAssist® program and be willing to comply with its requirements * No neurosensory or neuromotor dysfunction ≥ grade 3 * No known HIV positivity or active hepatitis B or C (hepatitis B surface antigen positivity or hepatitis C RNA positivity) * No known hypersensitivity to thalidomide or erythema nodosum characterized by desquamating rash while taking thalidomide or other similar drugs * No history of allergy to platinum or any of its derivatives or E. coli-derived products * No other malignancies within the past 5 years, except treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or any surgically cured malignancy from which the patient has been disease-free for ≥ 5 years * No NYHA class III-IV congestive heat failure (no symptoms on less than ordinary exertion or at rest) * No uncontrolled or intercurrent disease, including any of the following: * Arrhythmias * Angina pectoris * Active infection or fever \> 38.2 C (unless due to lymphoma) * No serious medical condition, laboratory abnormality, or psychiatric illness that would place patient at risk in study or confound ability to interpret study data PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior gemcitabine hydrochloride, oxaliplatin, or lenalidomide * Prior rituximab allowed * No more than 4 prior regimens of chemotherapy allowed, including stem cell or bone marrow transplantation * More than 2 weeks since prior and no concurrent anticancer therapy, including radiotherapy, hormonal therapy, or surgery * More than 3 weeks since prior chemotherapy or radiotherapy * More than 28 days since prior and no other concurrent investigational drug trial or investigational agent * Able to take aspirin (81 mg or 325 mg) daily or low molecular weight heparin as prophylactic anticoagulation * No concurrent thalidomide

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centro de Cancer del Hospital Auxilio Mutuo

San Juan, 00936-2712, Puerto Rico

RECRUITING

MeSH Terms

Conditions

LymphomaLymphoma, T-Cell, PeripheralBurkitt LymphomaLymphoma, Large B-Cell, DiffusePrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Follicular

Interventions

RituximabGemcitabineLenalidomideOxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-HodgkinEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoordination Complexes

Study Officials

  • Fernando Cabanillas, MD

    Auxilio Mutuo Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 3, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2013

Last Updated

January 10, 2014

Record last verified: 2011-02

Locations

PR(1)