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Diffuse Large B-cell LymphomaPhase 2NCT00869999

Everolimus Plus Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

A Phase 2 study testing Everolimus and rituximab in people with Diffuse Large B-cell Lymphoma, run by Massachusetts General Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Everolimus is an oral mTOR inhibitor with demonstrated preliminary efficacy and safety in diffuse large B-cell lymphoma (DLBCL) in both preclinical and clinical studies. The purpose of this research study is to determine whether Everolimus plus rituximab is safe and effective in participants with relapsed or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
Everolimus and rituximab
How many people
26 participants
Where
2 sitesUnited States
Study dates
May 2009to Nov 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Histologically determined DLBCL that is relapsed or primary refractory after initial therapy
  • Greater than 1 prior line of chemotherapy (including an anthracycline unless contraindicated) or immunotherapy. Patients must have relapsed after autologous stem cell transplantation, not be eligible for autologous stem call transplantation in the judgment of the investigator, or refuse autologous stem cell transplantation. Salvage chemotherapy and high dose conditioning for autologous stem cell transplantation count as two separate regimens.
  • Measurable disease that has not been previously irradiated on PET-CT of at least 2cm, OR if the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation. Imaging must be completed no greater than 3 weeks from study enrollment.
  • ECOG performance status 0-2
  • 18 years of age or older
  • Life expectancy of greater than 3 months
  • Adequate Organ and marrow function
  • Fasting serum cholesterol of 300 mg/dl or less OR 7.75 mmol/L or less AND fasting triglycerides 2.5 x ULN or less

Who cannot join

  • Currently receiving anticancer therapies or who have received anticancer therapies within 3 weeks of the start of the study drug
  • Receiving any other investigational agents, or have received investigational agents within 4 weeks of beginning treatment
  • Major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
  • Known leptomeningeal or brain metastases. Imaging or spinal fluid analysis to exclude CNS involvement is not required, unless there is clinical suspicion by the treating investigator
  • Known HIV infection
  • Systemic fungal, bacterial, viral, or other infection not controlled
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  • Prior history of malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least one year. Patients with prostate cancer are allowed if PSA is less than 1
  • Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
  • Severely impaired lung function defined as DLCO of <60%
  • Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN
  • Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of Everolimus
  • Active bleeding diathesis
  • Female patients who are pregnant or breastfeeding, or adults of reproductive potential who are not using effective birth control methods
  • Prior treatment with an mTOR inhibitor
  • Known hypersensitivity to murine antibodies,everolimus,other rapamycin
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • No chronic treatment with systemic corticosteroids or other immunosuppressive agents. Topical or inhaled corticosteroids are permitted

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconsess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Everolimus in Combination With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

Everolimus is an oral mTOR inhibitor with demonstrated preliminary efficacy and safety in diffuse large B-cell lymphoma (DLBCL) in both preclinical and clinical studies. The purpose of this research study is to determine whether Everolimus plus rituximab is safe and effective in participants with relapsed or refractory DLBCL. Everolimus is an investigational drug that works by blocking a special protein that helps cancer cells grow. The safety and effectiveness of Everolimus in the treatment of DLBCL has not yet been fully determined and is still investigational. The other drug in this study, rituximab, is approved by the US Food and Drug Administration (FDA) for use in patients who have diffuse large B-cell lymphoma and certain other types of non-Hodgkin lymphoma. Rituximab is a drug that destroys both normal and cancerous B-cells.

Read the detailed description

Participants will receive oral Everolimus and intravenous rituximab for DLBCL that has relapsed or been refractory to prior therapy.

  • Each treatment cycle lasts 28 days (4 weeks). Everolimus will be taken orally, once daily in the morning.
  • Rituximab will be administered by an intravenous (IV) infusion on Days 1, 8, 15 and 22 of Cycle 1. In Cycles 2-6, rituximab will be administered only on Day 1 of each cycle.
  • Participants will come into the clinic weekly during the first cycle, then on Day 1 of all cycles thereafter. The following tests and procedures will be performed:
  • Weekly During Cycle 1: blood tests
  • Day 1 of all Subsequent Cycles: brief physical examination; review of current medications, treatments, symptoms and side effects; vital signs; performance status evaluation; blood tests.
  • A full body CT and PET scan to assess the participants tumor will be done within 7 days of completing cycles 2, 4, 6, 9 and 12.

Responding subjects may receive up to 6 cycles of Everolimus plus rituximab, and an additional 6 months of oral Everolimus for participants continuing to respond.

Being tested
Everolimus, rituximab
Keywords
rituximab, everolimus, DLBCL, mTOR
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • EverolimusDrug

    Taken orally once daily in the morning

  • rituximabDrug

    Given intravenously on Days 1, 8, 15, and 22 of Cycle 1 then on Day 1 of cycles 2-6

What is being measured

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

  1. Overall Response Rate

    Complete response plus partial response after 6 cycles. Response rate will be evaluated by using the modified Cheson criteria for lymphoma response. Complete response requires all of the following: 1) PET positive prior to therapy: mass of any size permitted if PET negative. Variable FDG-avid or PET negative prior to therapy: regression to normal size on CT (</= 1.5cm in their greatest transverse diameter for nodes >/= 1.5 cm before therapy) 2) Spleen (if enlarged before therapy) must have regressed in size and must not be palpable, 3) If bone marrow is known to be involved, repeat biopsy documents clearance. Partial response requires 1) >/= 50% decrease in SPD, 2) No new sites of disease or increase in the size of other nodes, liver or spleen, 3) Splenic and hepatic nodules must regress by at least 50% in SPD

    Measured: Assessed at the conclusion of cycle 2, cycle 4 and cycle 6

Secondary outcomes (2)

  1. Duration of Overall Response

    Duration of overall response is measured from the time measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented.

    Measured: 2 years

  2. Progression-free Survival

    Progression-free survival is defined as the duration of time from start of treatment to time of documentation of progression or death

    Measured: 2 years

Timeline

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

  1. First posted26 Mar 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionNov 2011
  4. Study completionNov 2011

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
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00869999
Sponsor's protocol ID
09-002
Status last verified
Oct 2013
First submitted
25 Mar 2009
Last updated
27 Oct 2014
Data monitoring committee
Yes

Publications

  • Barnes JA, Jacobsen E, Feng Y, Freedman A, Hochberg EP, LaCasce AS, Armand P, Joyce R, Sohani AR, Rodig SJ, Neuberg D, Fisher DC, Abramson JS. Everolimus in combination with rituximab induces complete responses in heavily pretreated diffuse large B-cell lymphoma. Haematologica. 2013 Apr;98(4):615-9. doi: 10.3324/haematol.2012.075184. Epub 2012 Nov 9.

    PubMed 23144193

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus and rituximab in people with Diffuse Large B-cell Lymphoma, run by Massachusetts General Hospital at 2 sites in United States.

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

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. 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: finished, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 27 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: Assessed at the conclusion of cycle 2, cycle 4 and cycle 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00869999, which also lists 1 linked publication.

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 27 Oct 2014.

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