Trial Outcomes & Findings for Lenalidomide After Allo-Hematopoietic Cell Transplant (HCT) in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS) Subjects With Minimal Residual Disease (NCT NCT02370888)

Last Updated: 2020-01-27

Results Overview

To determine safety and the maximum tolerated dose of lenalidomide after allo-HCT in AML and MDS subjects with MRD detected by the CD34+ mixed chimerism analysis.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

Up to 72 days

Results posted on

2020-01-27

Participant Flow

Per protocol, enrollment is completion of informed consent. 11 subjects were enrolled- 2 did not meet eligibility and 9 did. Of the 9 eligible subjects- 3 received protocol treatment assignment, 5 did not have their chimerism drop, per protocol, below 90% at day 60 or 90 post-transplant, and 1 withdrew consent prior to assignment.

Participant milestones

Participant milestones
Measure	Dose Escalation of Lenalidomide Participants in the Arm only received Dose Level 1: 2.5 mg PO QOD Day 1-21 for 28-day cycle X 2 cycles
Overall Study STARTED	9
Overall Study Proceed to Treatment	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Escalation of Lenalidomide Participants in the Arm only received Dose Level 1: 2.5 mg PO QOD Day 1-21 for 28-day cycle X 2 cycles
Overall Study disease progression	2
Overall Study did not meet chimerism criteria	6

Baseline Characteristics

Lenalidomide After Allo-Hematopoietic Cell Transplant (HCT) in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS) Subjects With Minimal Residual Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 n=3 Participants 2.5 mg PO QOD Day 1-21 for 28 day cycle X 2 Enrolled 3 subjects	Dose Level 2 2.5 mg PO QD Day 1-21 for 28 day cycle X 2 cycles	Dose Level 3 5 mg PO QD Day 1-21 for 28 day cycle X 2 cycles	Dose Level 4 7.5 mg PO QD Day 1-21 for 28 day cycle X 2 cycles	Total n=3 Participants Total of all reporting groups
Age, Customized	3 Participants n=99 Participants	—	—	—	3 Participants n=31 Participants
Sex: Female, Male Gender · Female	1 Participants n=99 Participants	—	—	—	1 Participants n=31 Participants
Sex: Female, Male Gender · Male	2 Participants n=99 Participants	—	—	—	2 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	—	—	—	0 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=99 Participants	—	—	—	3 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	—	—	—	0 Participants n=31 Participants
Number of Participants with CD34 donor chimerism drop	3 Participants n=99 Participants	—	—	—	3 Participants n=31 Participants

PRIMARY outcome

Timeframe: Up to 72 days

Population: Cohort requirements for analysis not met. MTD could not be assessed as only a single dose level was tested. No dose escalation was performed.

To determine safety and the maximum tolerated dose of lenalidomide after allo-HCT in AML and MDS subjects with MRD detected by the CD34+ mixed chimerism analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 120 days

Population: No participant met the requirements for the efficacy population (at least 21 days of the study drug and at least one post-cycle efficacy assessment). Therefore, no data were collected for this assessment.

To monitor changes in the CD34+ mixed chimerism after allo-HCT in AML and MDS subjects with detectable MRD in response to escalating doses of lenalidomide.

Outcome measures

Outcome data not reported

Adverse Events

Dose Level 1: 2.5 mg PO QOD Day 1-21 for 28 Day Cycle X 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dose Level 1: 2.5 mg PO QOD Day 1-21 for 28 Day Cycle X 2 n=3 participants at risk Subjects will be enrolled in cohorts of three (3). Lenalidomide will be administered for 21 consecutive days in a 28 day cycle X 2 cycles.
Blood and lymphatic system disorders Blood and lymphatic system disorders	66.7% 2/3 • Number of events 2 • 9 months
General disorders General disorders and administration site conditions	66.7% 2/3 • Number of events 4 • 9 months
Investigations Investigations	66.7% 2/3 • Number of events 18 • 9 months
Metabolism and nutrition disorders Metabolism and nutrition disorders	66.7% 2/3 • Number of events 5 • 9 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	66.7% 2/3 • Number of events 10 • 9 months
Gastrointestinal disorders Gastrointestinal disorders	33.3% 1/3 • Number of events 5 • 9 months
Infections and infestations Infections and infestations	33.3% 1/3 • Number of events 1 • 9 months
Nervous system disorders Nervous system disorders	33.3% 1/3 • Number of events 2 • 9 months

Additional Information

Archana Narasanna, Project Manager

Univeristy of Florida Health Cancer Center

Phone: (352) 273-6772

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place