Trial Outcomes & Findings for Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL) (NCT NCT00899431)

Last Updated: 2020-01-27

Results Overview

To compare the need for immunomanipulation within 18 months after non-myeloablative allogeneic transplantation for CLL between the two combination therapies with or without lenalidomide maintenance. For this purpose, "immunomanipulation" is defined as any one of the following events: 1) Cessation of administering tacrolimus treatment with in the first 6 months after allotransplant due to persistent disease or progression. 2) Boost of donor lymphocytic infusion (DLI) administered anytime between 3 and 18 months after allotransplant.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Up to 18 months after allotransplant.

Results posted on

2020-01-27

Participant Flow

Recruitment was from May 2009 to November 2012 for subjects with chronic lymphocytic leukemia (CLL) who had relapsed after failing conventional chemo-antibody combination therapy, or failed to achieve a Crwith frontline conventional chemo-antibody, or have 17p deletion, or in Richter's.

Patients were randomized at a 1:1 ratio to receive lenalidomide 90 to 100 days after allo SCT if they had persistent active CLL

Participant milestones

Participant milestones
Measure	Not Randomized Did not meet the necessary criteria after transplantation to be randomized for maintenance.	Randomized to Lenalidomide 1:1 randomization. This group receive the study drug Lenalidomide.	Randomized to Not Receive Lenalidomide 1:1 randomized. This group did not receive lenalidomide.
Overall Study STARTED	22	8	9
Overall Study COMPLETED	21	8	9
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Not Randomized Did not meet the necessary criteria after transplantation to be randomized for maintenance.	Randomized to Lenalidomide 1:1 randomization. This group receive the study drug Lenalidomide.	Randomized to Not Receive Lenalidomide 1:1 randomized. This group did not receive lenalidomide.
Overall Study Physician Decision	1	0	0

Baseline Characteristics

Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=21 Participants Not Randomized	Group 2 n=8 Participants Randomized to Lenalidomide	Group 3 n=9 Participants Randomized to not receive lenalidomide	Total n=38 Participants Total of all reporting groups
Age, Continuous	60 Years n=5 Participants	55 Years n=7 Participants	56 Years n=5 Participants	58 Years n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	30 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	21 participants n=5 Participants	8 participants n=7 Participants	9 participants n=5 Participants	38 participants n=4 Participants
Conditioning regimen FCR	12 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	25 Participants n=4 Participants
Conditioning regimen BRF	9 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 18 months after allotransplant.

Population: Data were not collected due to low accrual of participants and protocol was terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months after allotransplant

Acute grade 2 to 4 Graft versus host disease( GVHD )for patients who were able to be analyzed by measuring the T cell counts for increased CD3+ before and after lenalidomide.

Outcome measures

Outcome measures
Measure	Not Randomized n=21 Participants Did not meet the necessary criteria after transplantation to be randomized for maintenance.	Randomized to Lenalidomide n=8 Participants 1:1 randomization. This group receive the study drug Lenalidomide.	Randomized to Not Receive Lenalidomide n=9 Participants 1:1 randomized. This group did not receive lenalidomide.
Percentage of Participants With GVHD (Graft Versus Host Disease)	0 Participants	3 Participants	1 Participants

Adverse Events

Group 1

Serious events: 3 serious events

Other events: 19 other events

Deaths: 2 deaths

Group 2

Serious events: 0 serious events

Other events: 8 other events

Deaths: 1 deaths

Group 3

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=21 participants at risk Not Randomized	Group 2 n=8 participants at risk Randomized to Lenalidomide	Group 3 n=9 participants at risk Randomized to not receive lenalidomide
Skin and subcutaneous tissue disorders Skin GVHD	4.8% 1/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Blood and lymphatic system disorders TIA	4.8% 1/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Cardiac disorders Graft Failure	4.8% 1/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)

Other adverse events

Additional Information

Dr. Issa F. Khouri, MD/Professor, Stem Cell Transplantation

The University of Texas MD Anderson Cancer Center

Phone: 713- 745-0049

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group 1 n=21 participants at risk Not Randomized	Group 2 n=8 participants at risk Randomized to Lenalidomide	Group 3 n=9 participants at risk Randomized to not receive lenalidomide
Blood and lymphatic system disorders Epitaxis	4.8% 1/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Blood and lymphatic system disorders Graf Failure	0.00% 0/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	25.0% 2/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	11.1% 1/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Cardiac disorders DVT	19.0% 4/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	11.1% 1/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Cardiac disorders A-fib	4.8% 1/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	11.1% 1/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Cardiac disorders Angina	4.8% 1/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Cardiac disorders Hypertension	14.3% 3/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	12.5% 1/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Cardiac disorders Hypotension	4.8% 1/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	12.5% 1/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
General disorders Fatigue	4.8% 1/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Hepatobiliary disorders Ascites	4.8% 1/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Gastrointestinal disorders Diarrhea	52.4% 11/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	37.5% 3/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	11.1% 1/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Gastrointestinal disorders GI GVHD	66.7% 14/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	12.5% 1/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	66.7% 6/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Gastrointestinal disorders Nausea	90.5% 19/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	75.0% 6/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	100.0% 9/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Renal and urinary disorders Elevated creatinine	28.6% 6/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	37.5% 3/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	11.1% 1/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Renal and urinary disorders Cystitis	23.8% 5/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	11.1% 1/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Hepatobiliary disorders Elevated Bilirubin	33.3% 7/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	25.0% 2/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Hepatobiliary disorders Liver GVHD	4.8% 1/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	11.1% 1/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Hepatobiliary disorders Transminitis	42.9% 9/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	37.5% 3/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	11.1% 1/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Infections and infestations Nuetropenic infection	19.0% 4/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	50.0% 4/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	33.3% 3/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Infections and infestations Infection	76.2% 16/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	75.0% 6/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	66.7% 6/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Endocrine disorders Hyperglycemia	14.3% 3/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	12.5% 1/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	11.1% 1/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Musculoskeletal and connective tissue disorders Bone Pain	23.8% 5/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	0.00% 0/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	22.2% 2/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Eye disorders Occular GVHD	14.3% 3/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	25.0% 2/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	11.1% 1/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Respiratory, thoracic and mediastinal disorders Pnuemonitis	4.8% 1/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	12.5% 1/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	22.2% 2/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Skin and subcutaneous tissue disorders Skin GVHD	52.4% 11/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	62.5% 5/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	77.8% 7/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)
Skin and subcutaneous tissue disorders Skin Rash	19.0% 4/21 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	12.5% 1/8 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)	33.3% 3/9 • Adverse events were collected from start of study drug to 30 days post study drug completion (May 2009 to November 2015)