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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

Phase 2
18 Years
Open (Enrolling)

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Trial Information

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



- 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).


- 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

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

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.

Inclusion Criteria


- 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


- 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

- 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

- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:


Principal Investigator

Fernando Cabanillas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Auxilio Mutuo Cancer Center



Study ID:




Start Date:

February 2011

Completion Date:

Related Keywords:

  • Lymphoma
  • peripheral T-cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin