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LymphomaPhase 2NCT01307592

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

A Phase 2 study testing rituximab, gemcitabine hydrochloride and lenalidomide in people with Lymphoma, run by Auxilio Mutuo Cancer Center at 1 site in Puerto Rico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
rituximab, gemcitabine hydrochloride and lenalidomide
How many people
70 participants
Where
1 sitePuerto Rico
Study dates
Feb 2011to Feb 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Puerto Rico1 site, 1 recruiting
  • Centro de Cancer del Hospital Auxilio Mutuo

    San Juan, 00936-2712

    Clinical Trial Coordinator, 787-771-7933 ext. 3569, iliboy@auxiliomutuo.com

    Recruiting

Other trials in Puerto Rico

About this study

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

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.

Read the 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.

Conditions
Lymphoma
Keywords
peripheral T-cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 3 follicular lymphoma
Medical subject headings
Lymphoma, Lymphoma, T-Cell, Peripheral, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)
  1. Overall survival

  2. Progression-free survival

  3. Safety of this regimen combination

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionFeb 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01307592
Sponsor's protocol ID
CDR0000695874
Other IDs
CAM-09-01, CELGENE-RV-NHL-PI-0452
Status last verified
Feb 2011
First submitted
1 Mar 2011
Last updated
10 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab, gemcitabine hydrochloride and lenalidomide in people with Lymphoma, run by Auxilio Mutuo Cancer Center at 1 site in Puerto Rico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of conversion to complete response (CR) after switching to lenalidomide. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.

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