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Lenalidomide + Ipilimumab for Blood Cancers

Phase 2
Waitlist Available
Led By Issa Khouri
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Serum creatinine =< 1.6 mg/dL and creatinine clearance >= 30 ml/min
SGPT, SGOT less than 2 x the upper limit of normal range (unless related to Gilbert's disease or medications)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial looks at the side effects of two cancer treatments: lenalidomide and ipilimumab. Lenalidomide stimulates or suppresses the immune system, and ipilimumab helps the body's immune system attack the cancer.

Who is the study for?
This trial is for patients with blood cancers like multiple myeloma or lymphomas who've had a stem cell transplant. They should be infection-free, have good organ function and performance status, and not be pregnant. Those with severe neuropathy, recent heart issues, active autoimmune diseases, or certain infections can't join.Check my eligibility
What is being tested?
The trial tests lenalidomide and ipilimumab after a stem cell transplant in patients with hematologic malignancies. Lenalidomide may stimulate the immune system to stop cancer growth while ipilimumab could help the body attack cancer cells more effectively.See study design
What are the potential side effects?
Possible side effects include immune system reactions that might affect organs, infusion-related symptoms, increased risk of infections due to immune suppression by lenalidomide and ipilimumab, as well as potential impact on blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is within the required range.
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My liver tests are within normal limits, except for conditions like Gilbert's disease.
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I had a stem cell transplant within the last 6 months and my condition hasn't worsened.
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I do not have any current infections.
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My heart pumps well, with an ejection fraction of 45% or higher.
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My direct bilirubin level is below 1.6, not due to Gilbert's disease or medications.
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I can take care of myself but might not be able to do active work.
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I have a blood or lymph cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Toxicity rate
Secondary outcome measures
Cumulative incidence of acute graft-versus-host disease
Cumulative incidence of chronic graft-versus-host disease
Incidence of other organ toxicity
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (lenalidomide and ipilimumab)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Lenalidomide
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,408 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,605 Total Patients Enrolled
Issa KhouriPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
67 Total Patients Enrolled

Media Library

Lenalidomide Clinical Trial Eligibility Overview. Trial Name: NCT01919619 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Treatment (lenalidomide and ipilimumab)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT01919619 — Phase 2
Lenalidomide 2023 Treatment Timeline for Medical Study. Trial Name: NCT01919619 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals would qualify to partake in this clinical experiment?

"Qualified candidates must have been diagnosed with leukemia, and should be between 18-80 years of age. This investigation is taking on around 41 participants."

Answered by AI

What are the applications of Lenalidomide in medical treatment?

"Lenalidomide is usually prescribed after two other systemic cancer treatments have been attempted. Its scope extends beyond this to encompass conditions like cutaneous melanoma, metastatic melanoma, and intermediate risk cases."

Answered by AI

Is this experiment open to elderly participants aged 85 or above?

"According to the eligibility requirements, individuals aged between 18 and 80 may enroll in this clinical trial. In total, 664 trials are available for minors while 3782 studies target adults over 65."

Answered by AI

What is the upper limit of participants engaged in this experiment?

"At this time, individuals are not being sought to participate in the study. It was initially posted on November 4th 2013 and last updated October 6th 2022. There exist 3,593 clinical trials actively recruiting patients with leukemia and 584 studies using Lenalidomide as an intervention currently seeking participants."

Answered by AI

What safety protocols are in place for administering Lenalidomide to patients?

"Although lenalidomide has yet to be proven efficacious, there is data suggesting it can reduce harm. Consequently, this medication was assigned a score of 2 on our safety scale."

Answered by AI

Is recruitment still ongoing for this trial?

"At present, no further individuals are being sought for this clinical trial which was originally posted on November 4th 2013 and last edited October 6th 2022. For persons looking to participate in a different medical study there are 3593 trials actively recruiting leukemia patients and 584 studies currently searching for Lenalidomide participants."

Answered by AI

Has Lenalidomide been the subject of prior clinical investigations?

"Currently, 584 clinical trials are underway that involve Lenalidomide. Out of these studies, 94 have progressed to Phase 3. Trials for this medication primarily take place in Pittsburgh, Pennsylvania; however, a total of 33,571 locations across the world are currently running such tests."

Answered by AI
~4 spots leftby Mar 2025