The following article features coverage from the American Society of Hematology 2021 meeting. Click here to read more of Hematology Advisor‘s conference coverage.

Addition of lenalidomide (Len) to the combination of azacitidine (AZA) and donor lymphocyte infusions (DLI) appears to be feasible and safe as salvage therapy after allogeneic blood stem cell transplantation (allo-SCT), according to research presented at the 2021 American Society of Hematology (ASH) Annual Meeting.

The findings, which were presented by Thomas Schroeder, MD, of the University Hospital Essen in Germany, represent the final results of the prospective AZALENA trial ( Identifier: NCT02472691).

“[R]elapse after allogeneic transplantation is the major course of treatment failure in patients with AML and MDS and is associated with a dismal prognosis,” said Dr Schroeder. “[We] considered lenalidomide to be an attractive combination partner [with hypomethylating agents] due to its synergistic antileukemic and immunomodulatory properties.”

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The investigators evaluated the tolerability and efficacy of the combination of AZA and DLI plus Len as first salvage therapy for relapsed myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML) after first allo-SCT in a prospective, multicenter, single-arm, investigator-initiated, phase 2 trial.

Patients received up to 8 cycles of AZA (75 mg/m2/day, days 1-7, every 28 days) and up to 3 cycle of DLI with increasing T cell dosages (0.5×106 to 1.5×107 cells/kg). Concomitant Len (up to 5 mg/day) was administered for 21 days of a 28-day cycle. The primary endpoint was safety. Secondary efficacy endpoints included response type and rates, time to and duration of response, and overall survival (OS).

A total of 50 patients, with a median age of 63 years (range, 30-75), who experienced molecular (58%) or hematological (42%) relapse of MDS (48%), AML (46%) or CMML (6%) were included in the study. Among all patients, time to relapse was a median of 233 days (range, 98-2659) after allo-SCT. For the interim analysis, 28% and 72% of patients had received Len at a dosage of 2.5 mg and 5 mg, respectively, with no dose-limiting toxicities. Patients had a median of 7 Len cycles (range, 1-8). Concomitant DLI (median, 3; range, 1-11) was administered to 68% of patients.

Therapy-related adverse events (AEs) included grade 3/4 neutropenia (92%), thrombopenia (80%), and anemia (36%). Drug-related non-hematological AEs higher than grade 2 included gastrointestinal toxicity (6%), laboratory findings (28%), and infections (22%). Acute and chronic graft-versus-host disease (GVHD) were reported in 46% and 52% of patients, respectively. No therapy-related deaths occurred.

Overall response rate (ORR) during treatment was 56%, with 25 (50%) complete remissions (CR) and 3 partial remissions (6%). No differences were observed in ORR and CR rates between Len dose levels. The median time to CR was 112 days (range, 1-286). Most (80%) patients who achieved CR remained in CR without additional therapy for a median of 15 months (range, 6-21). At a median follow-up duration of 20 months, the median OS was 21 months, and the 1-year OS rate was 65%.

“Encouraging response rates, duration of response, and survival were observed, including patients with early or hematological relapse; AZA, Len, and  DLI favorably modulates the balance between [graft versus leukemia] and GVHD, and is an efficient treatment option for patients with myeloid neoplasms relapsing after transplantation,” concluded Dr Schroeder.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

Read more of Hematology Advisor‘s coverage of the ASH 2021 meeting by visiting the conference page.


Schroeder T, Stelljes M, Maximilian Christopeit M, et al. Treatment of MDS, AML and CMML relapse after allogeneic blood stem cell transplantation with azacitidine, lenalidomide and donor lymphocyte infusions – final results of the prospective azalena-trial (NCT02472691). Presented at ASH 2021; December 11-14, 2021. Abstract 411.