Phase 2
N=41
Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies
B-Cell Non-Hodgkin Lymphoma · Hematopoietic and Lymphoid Cell Neoplasm · Leukemia · Lymphoma · Plasma Cell Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01919619 ↗Enrolled (actual)
41
Serious AEs
29.3%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants Experienced Severe Toxicity From Lenalidomide and Ipilimumab Post Transplant — 10; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ipilimumab (Biological); Lenalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experienced Severe Toxicity From Lenalidomide and Ipilimumab Post Transplant |
10; 2 | — |
| SECONDARY Number of Participants Achieved Complete Remission |
22; 5 | — |
| SECONDARY Progression-free Survival |
18; 4 | — |
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. 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.
Eligibility Criteria
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 = = 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 = = 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 10 mg prednisone (or equivalent)
- Prior auto-immune disease
Data sourced from ClinicalTrials.gov (NCT01919619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.