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B-Cell Non-Hodgkin LymphomaPhase 2NCT01919619

Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies

A Phase 2 study testing Ipilimumab and Lenalidomide in people with B-Cell Non-Hodgkin Lymphoma and Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 1 site 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

This pilot clinical trial studies the side effects of lenalidomide and ipilimumab after stem cell transplant in treating patients with hematologic or lymphoid malignancies. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Ipilimumab and Lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
4 Nov 2013to 3 May 2024
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hematologic or lymphoid malignancy
  • Autologous patients can be included anytime within 6 months post-transplant, if they had no signs of progression and meet one of the following criteria: i. leukemia; ii. lymphoma (all types of B and T cell lymphoma); iii. multiple myeloma
  • Allogeneic patients if: i. patients had engrafted donor cells (i.e., > 20% donor T-cell from peripheral blood [PB]/polymerase chain reaction [PCR]); and, ii. patients NOT in complete remission (CR) after their allogeneic transplant, and off tacrolimus and/or mycophenolate mofetil for at least 3 to 4 weeks with no signs of GVHD; or, iii. patients had evidence of relapse after their transplant who are off tacrolimus and/or mycophenolate mofetil or other immunosuppressants for GVHD for 3 to 4 weeks with no signs of GVHD (prednisone doses =< 10 mg are permitted as stated previously)
  • No active infection
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • Platelets > 75 x 10^9/L
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  • Able to adhere to the study visit schedule and other protocol requirements
  • Performance status: Eastern Cooperative Oncology Group (ECOG) 2 or less or Karnofsky of at least 60
  • Cardiac ejection fraction (EF) >= 45% by 2-dimensional echocardiogram (2D-ECHO) within 3 months of study entry (or within 1 month if received chemotherapy within the past 3 months)
  • Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO) >= 40% within 3 months of study entry (or within 1 month if received chemotherapy within the past 3 months)
  • Serum creatinine =< 1.6 mg/dL and creatinine clearance >= 30 ml/min; creatinine clearance will be calculated using the Cockcroft-Gault equation
  • Serum glutamate pyruvate transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT) less than 2 x the upper limit of normal range (unless related to Gilbert's disease or medications)
  • Direct bilirubin < 1.6 (unless related to Gilbert's disease or medications)
  • Patient or legally authorized representative able to sign informed consent
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to study entry

Who cannot join

  • Immunotherapy or chemotherapy with approved or investigational anticancer therapeutics within 4 weeks of first dose
  • Patients on alemtuzumab within 6 weeks prior to consenting
  • Active congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic ischemia or conduction abnormalities uncontrolled by conventional interventions; myocardial infarction within 6 months of study entry
  • Deep vein thrombosis or pulmonary embolism within 3 months of study entry
  • Pregnant or breast-feeding females; (lactating females must agree not to breast-feed while taking lenalidomide)
  • Acute active infection requiring intravenous antibiotics, antiviral (except antiviral directed at hepatitis B), or antifungal agents within 14 days of first dose
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  • Known human immunodeficiency virus (HIV) seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen [Sag] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
  • Patients with other known malignancies within the past three years except: i. adequately treated basal or squamous cell skin cancer; ii. carcinoma in situ of the cervix; iii. prostate cancer with Gleason score < 6 with stable prostate-specific antigen (PSA) over the past three months; iv. breast cancer in situ with full surgical resection
  • Significant neuropathy (grades 3 to 4 or grade 2 pain)
  • Known hypersensitivity to thalidomide, lenalidomide or ipilimumab
  • Active life-threatening autoimmune disease
  • Active GVHD or recent GVHD and still on > 10 mg prednisone (or equivalent)
  • Prior auto-immune disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Pilot Study of Lenalidomide Alternating With Ipilimumab Post Allogeneic and Autologous Stem Cell Transplantation

This pilot clinical trial studies the side effects of lenalidomide and ipilimumab after stem cell transplant in treating patients with hematologic or lymphoid malignancies. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide with ipilimumab may be a better treatment for hematologic or lymphoid malignancies.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the safety of lenalidomide in combination with ipilimumab in autologous and allogeneic stem cell transplantation.

SECONDARY OBJECTIVES:

  1. Overall response rate. II. Overall survival, progression-free survival. III. Cumulative incidence of acute and chronic graft-versus-host disease (GVHD) with the competing risk of relapse in allogeneic transplant patients.

OUTLINE:

Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21 of courses 1, 3, 5 and 7. Beginning 1-3 days after the last dose of lenalidomide patients receive one dose of ipilimumab intravenously (IV) over 90 minutes of courses 2, 4, 6 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, 6, 12, 24, and 36 months.

Medical subject headings
Lymphoma, B-Cell, Hematologic Neoplasms, Leukemia, Lymphoma, Multiple Myeloma, Lymphoma, T-Cell

What participants receive

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

  • IpilimumabBiological

    Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, MDX-CTLA4

    Given IV

  • LenalidomideDrug

    Also called CC-5013, CC5013, CDC 501, Revlimid

    Given PO

Study groups in NCT01919619
Study groupRoleWhat they receive
Treatment (lenalidomide and ipilimumab)ExperimentalPatients receive lenalidomide PO QD on days 1-21 of courses 1, 3, 5 and 7. Beginning 1-3 days after the last dose of lenalidomide patients receive one dose of ipilimumab IV over 90 minutes of courses 2, 4, 6 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Ipilimumab; Drug: Lenalidomide

What is being measured

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

  1. Number of Participants Experienced Severe Toxicity From Lenalidomide and Ipilimumab Post Transplant

    Any grade 4 hematological toxicity or grade 3-5 organ toxicity 30 days following the last dose of study drug.

    Measured: Up to 30 days following the last dose of study drugs

Secondary outcomes (2)

  1. Number of Participants Achieved Complete Remission

    CR is defined as a complete resolution of all target lesions by CT scans with complete normalization of FDG-PET uptake in all areas, and bone marrow biopsy negativity.

    Measured: Up to 30 days following the last dose of study drug

  2. Progression-free Survival

    Number of participants that are alive and disease free 36 months long post transplant

    Measured: Up to 36 months

Timeline

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

  1. First posted9 Aug 2013 (estimated)
  2. Study start4 Nov 2013
  3. Primary completion3 May 2024
  4. Study completion3 May 2024

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01919619
Sponsor's protocol ID
2012-0947
Other IDs
NCI-2013-02213, 2012.0947, 2012-0947
Status last verified
Nov 2024
First submitted
7 Aug 2013
Last updated
3 Dec 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Khouri IF, Fernandez Curbelo I, Turturro F, Jabbour EJ, Milton DR, Bassett RL Jr, Vence LM, Allison JP, Gulbis AM, Sharma P. Ipilimumab plus Lenalidomide after Allogeneic and Autologous Stem Cell Transplantation for Patients with Lymphoid Malignancies. Clin Cancer Res. 2018 Mar 1;24(5):1011-1018. doi: 10.1158/1078-0432.CCR-17-2777. Epub 2017 Dec 15.

    PubMed 29246938

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ipilimumab and Lenalidomide in people with B-Cell Non-Hodgkin Lymphoma and Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 1 site 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 15 inclusion and 13 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 3 Dec 2024. 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 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 3 Dec 2024). 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?

Number of Participants Experienced Severe Toxicity From Lenalidomide and Ipilimumab Post Transplant (time frame: Up to 30 days following the last dose of study drugs). 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 NCT01919619, 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 3 Dec 2024.

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