Trial Outcomes & Findings for Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies (NCT NCT01919619)
NCT ID: NCT01919619
Last Updated: 2024-12-03
Results Overview
Any grade 4 hematological toxicity or grade 3-5 organ toxicity 30 days following the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Up to 30 days following the last dose of study drugs
Results posted on
2024-12-03
Participant Flow
All participants were registered in MD Anderson Cancer Center
Participant milestones
| Measure |
Autologous -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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
Allogeneic - 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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
13
|
|
Overall Study
COMPLETED
|
27
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Autologous -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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
Allogeneic - 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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies
Baseline characteristics by cohort
| Measure |
Autologous -Treatment (Lenalidomide and Ipilimumab)
n=28 Participants
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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
Allogeneic - Treatment (Lenalidomide and Ipilimumab)
n=13 Participants
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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
13 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days following the last dose of study drugsAny grade 4 hematological toxicity or grade 3-5 organ toxicity 30 days following the last dose of study drug.
Outcome measures
| Measure |
Autologous -Treatment (Lenalidomide and Ipilimumab)
n=28 Participants
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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
Allogeneic - Treatment (Lenalidomide and Ipilimumab)
n=13 Participants
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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
|---|---|---|
|
Number of Participants Experienced Severe Toxicity From Lenalidomide and Ipilimumab Post Transplant
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days following the last dose of study drugCR 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.
Outcome measures
| Measure |
Autologous -Treatment (Lenalidomide and Ipilimumab)
n=28 Participants
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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
Allogeneic - Treatment (Lenalidomide and Ipilimumab)
n=13 Participants
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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
|---|---|---|
|
Number of Participants Achieved Complete Remission
|
22 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsNumber of participants that are alive and disease free 36 months long post transplant
Outcome measures
| Measure |
Autologous -Treatment (Lenalidomide and Ipilimumab)
n=28 Participants
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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
Allogeneic - Treatment (Lenalidomide and Ipilimumab)
n=13 Participants
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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
|---|---|---|
|
Progression-free Survival
|
18 Participants
|
4 Participants
|
Adverse Events
Autologous -Treatment (Lenalidomide and Ipilimumab)
Serious events: 10 serious events
Other events: 25 other events
Deaths: 7 deaths
Allogeneic - Treatment (Lenalidomide and Ipilimumab)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Autologous -Treatment (Lenalidomide and Ipilimumab)
n=28 participants at risk
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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
Allogeneic - Treatment (Lenalidomide and Ipilimumab)
n=13 participants at risk
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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Low granulocyte
|
35.7%
10/28 • Number of events 10 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
Investigations
Low platelet
|
0.00%
0/28 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Viral
|
0.00%
0/28 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
Other adverse events
| Measure |
Autologous -Treatment (Lenalidomide and Ipilimumab)
n=28 participants at risk
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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
Allogeneic - Treatment (Lenalidomide and Ipilimumab)
n=13 participants at risk
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.
Ipilimumab: Given IV
Lenalidomide: Given PO
|
|---|---|---|
|
Metabolism and nutrition disorders
Other
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
2/28 • Number of events 2 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Investigations
ALK increased
|
42.9%
12/28 • Number of events 12 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
General disorders
AL OTH
|
0.00%
0/28 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Investigations
ALT increased
|
46.4%
13/28 • Number of events 13 • up to 36 months
|
53.8%
7/13 • Number of events 7 • up to 36 months
|
|
Investigations
Anemia
|
78.6%
22/28 • Number of events 22 • up to 36 months
|
53.8%
7/13 • Number of events 7 • up to 36 months
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
2/28 • Number of events 2 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
2/28 • Number of events 2 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Investigations
AST increased
|
46.4%
13/28 • Number of events 13 • up to 36 months
|
46.2%
6/13 • Number of events 6 • up to 36 months
|
|
Eye disorders
Blurred vision
|
7.1%
2/28 • Number of events 2 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
Infections and infestations
Bacterial
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/28 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Cardiac disorders
Chest pain
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Gastrointestinal disorders
Constipation
|
7.1%
2/28 • Number of events 2 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
6/28 • Number of events 6 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Investigations
Creatinine increased
|
25.0%
7/28 • Number of events 7 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/28 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
53.6%
15/28 • Number of events 15 • up to 36 months
|
30.8%
4/13 • Number of events 4 • up to 36 months
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28 • Number of events 3 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/28 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/28 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Cardiac disorders
Dysrhythmia
|
0.00%
0/28 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
General disorders
Edema
|
7.1%
2/28 • Number of events 2 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Endocrine disorders
EN OTH
|
10.7%
3/28 • Number of events 3 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
General disorders
Fatigue
|
32.1%
9/28 • Number of events 9 • up to 36 months
|
30.8%
4/13 • Number of events 4 • up to 36 months
|
|
General disorders
Fever
|
10.7%
3/28 • Number of events 3 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
General disorders
Flu like syndrome
|
17.9%
5/28 • Number of events 5 • up to 36 months
|
38.5%
5/13 • Number of events 5 • up to 36 months
|
|
General disorders
Fluid overload
|
0.00%
0/28 • up to 36 months
|
30.8%
4/13 • Number of events 4 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Gastrointestinal disorders
GI OTH
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
23.1%
3/13 • Number of events 3 • up to 36 months
|
|
Renal and urinary disorders
GU OTH
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Nervous system disorders
Headache
|
0.00%
0/28 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/28 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
2/28 • Number of events 2 • up to 36 months
|
23.1%
3/13 • Number of events 3 • up to 36 months
|
|
Metabolism and nutrition disorders
Hypertension
|
0.00%
0/28 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.1%
2/28 • Number of events 2 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.7%
3/28 • Number of events 3 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
2/28 • Number of events 2 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/28 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
Infections and infestations
IN FEC
|
10.7%
3/28 • Number of events 3 • up to 36 months
|
23.1%
3/13 • Number of events 3 • up to 36 months
|
|
Investigations
LDH increased
|
21.4%
6/28 • Number of events 6 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Blood and lymphatic system disorders
Low granulocyte
|
78.6%
22/28 • Number of events 48 • up to 36 months
|
100.0%
13/13 • Number of events 13 • up to 36 months
|
|
Investigations
Low platelet
|
89.3%
25/28 • Number of events 25 • up to 36 months
|
100.0%
13/13 • Number of events 13 • up to 36 months
|
|
Investigations
Lymphocytosis
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Metabolism and nutrition disorders
MT OTH
|
7.1%
2/28 • Number of events 2 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.7%
3/28 • Number of events 3 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
7/28 • Number of events 7 • up to 36 months
|
30.8%
4/13 • Number of events 4 • up to 36 months
|
|
Nervous system disorders
NE OTH
|
14.3%
4/28 • Number of events 4 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Oral mucositis
|
17.9%
5/28 • Number of events 5 • up to 36 months
|
15.4%
2/13 • Number of events 2 • up to 36 months
|
|
General disorders
Other
|
35.7%
10/28 • Number of events 10 • up to 36 months
|
23.1%
3/13 • Number of events 3 • up to 36 months
|
|
Nervous system disorders
Peripheral neuropathy
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
General disorders
PU OTH
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.9%
12/28 • Number of events 12 • up to 36 months
|
30.8%
4/13 • Number of events 4 • up to 36 months
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Investigations
T bilirubin increased
|
14.3%
4/28 • Number of events 4 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Vascular disorders
Thromboembolic event
|
3.6%
1/28 • Number of events 1 • up to 36 months
|
7.7%
1/13 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Viral
|
7.1%
2/28 • Number of events 2 • up to 36 months
|
30.8%
4/13 • Number of events 4 • up to 36 months
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
2/28 • Number of events 2 • up to 36 months
|
0.00%
0/13 • up to 36 months
|
|
Investigations
Wbc decreased
|
71.4%
20/28 • Number of events 38 • up to 36 months
|
76.9%
10/13 • Number of events 10 • up to 36 months
|
Additional Information
Issa Khouri, MD / Stem Cell Transplantation Department
M D Anderson Cancer Center
Phone: 713-792-8750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place