Gemcitabine Hydrochloride, Rituximab, Oxaliplatin, and Lenalidomide in Treating Patients With Relapsed or Refractory, Aggressive Non-Hodgkin Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01307592
First received: March 1, 2011
Last updated: January 9, 2014
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Drug: gemcitabine hydrochloride
Drug: lenalidomide
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of GC. (Gemcitabine-Rituximab-Oxaliplatin Combination) Given Every 14 Days With Maintenance Lenalidomide for the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate of conversion to complete response (CR) after switching to lenalidomide [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Safety of this regimen combination [ Designated as safety issue: Yes ]
  • Rate of conversion to partial response and CR of non-responders treated with lenalidomide [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: February 2011
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the rate of conversion to complete response (CR) after switching to lenalidomide in patients with relapsed or refractory, aggressive non-Hodgkin lymphoma whose maximum response to gemcitabine hydrochloride, rituximab, and oxaliplatin is a partial response (PR).

Secondary

  • To determine the overall survival of these patients treated with this regimen.
  • To determine the progression-free survival of patients with CR and PR.
  • To determine the treatment-related toxicity of this regimen combination in these patients.

OUTLINE: This is a multicenter study.

  • Rituximab, gemcitabine hydrochloride, and oxaliplatin: Patients with B-cell lymphoma receive rituximab IV on day 1; all patients receive gemcitabine hydrochloride IV over 30 minutes and oxaliplatin IV over 2 hours on day 1 or day 2*. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients with T-cell lymphoma proceed to chemotherapy on day 1 without receiving rituximab; patients with B-cell lymphoma receive chemotherapy on day 2.

Patients are reevaluated after 4 courses of therapy. Patients who achieve a complete response (CR) receive 2 more courses of therapy and then proceed to bone marrow transplantation (BMT); those that do not receive a BMT receive maintenance lenalidomide for 2 years. Patients who achieve a partial response (PR) and who are not candidate for autologous stem cell transplantation (ACT) are treated with lenalidomide**. Once patients with PR achieve a CR or < CR with lenalidomide treatment, they proceed to maintenance lenalidomide for 2 years, unless they become candidates for ACT***. Patients with stable disease or progressive disease after 4 courses of therapy are treated with lenalidomide, unless they become eligible for ACT***.

NOTE: **Patients in whom a delay of > 4 months would occur for ACT are treated with lenalidomide until 3 weeks prior to ACT.

NOTE: **Once eligible, patients proceed to ACT as soon as feasible.

  • Maintenance lenalidomide: Patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and periodically for toxicity analysis.

After completion of study treatment, patients are followed up at 28 days and then every 3 months thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307592

Locations
Puerto Rico
Centro de Cancer del Hospital Auxilio Mutuo Recruiting
San Juan, Puerto Rico, 00936-2712
Contact: Clinical Trial Coordinator    787-771-7933 ext. 3569    iliboy@auxiliomutuo.com   
Sponsors and Collaborators
Auxilio Mutuo Cancer Center
Investigators
Principal Investigator: Fernando Cabanillas, MD Auxilio Mutuo Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01307592     History of Changes
Other Study ID Numbers: CDR0000695874, CAM-09-01, CELGENE-RV-NHL-PI-0452
Study First Received: March 1, 2011
Last Updated: January 9, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
peripheral T-cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 3 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Thalidomide
Oxaliplatin
Rituximab
Lenalidomide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antirheumatic Agents
Leprostatic Agents
Anti-Bacterial Agents
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014