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

November 11, 2024 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. 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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (lenalidomide and ipilimumab)
Patients 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.
Biological: Ipilimumab
Given IV
Other Names:
  • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
  • BMS-734016
  • MDX-010
  • MDX-CTLA4
  • Yervoy
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • Revlimid
  • CC5013
  • CDC 501

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Any grade 4 hematological toxicity or grade 3-5 organ toxicity 30 days following the last dose of study drug.
Up to 30 days following the last dose of study drugs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Achieved Complete Remission
Time Frame: Up to 30 days following the last dose of study drug
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.
Up to 30 days following the last dose of study drug
Progression-free Survival
Time Frame: Up to 36 months
Number of participants that are alive and disease free 36 months long post transplant
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Issa Khouri, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2013

Primary Completion (Actual)

May 3, 2024

Study Completion (Actual)

May 3, 2024

Study Registration Dates

First Submitted

August 7, 2013

First Submitted That Met QC Criteria

August 7, 2013

First Posted (Estimated)

August 9, 2013

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0947 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2013-02213 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 2012.0947

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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