Phase 1-2 of Azacitidine + Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia (AML)

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia (AML); Adult Acute Myeloblastic Leukemia
• Interventions: Drug: Lenalidomide; Drug: Azacitidine

• Registration Number: NCT00890929
• Lead Sponsor: Stanford University

Brief Summary

This study has a phase 1 and a phase 2 component.

In phase 1, the objective is to determine the maximum tolerated dose (MTD) of lenalidomide when after azacitidine.

In phase 2, the objective is to determine the efficacy of the combination treatment.

Detailed Description

The treatment regimen in this study is 7 day courses of azacitidine 75 mg/m2 followed by a 21-day courses of lenalidomide. For the primary objective, each 28-day cycle was repeated for a total of up to 6 cycles. Study completion was defined as 18 cycles of treatment, disease progression, or death.

In phase 1, the objective was to determine the maximum tolerated dose (MTD) of lenalidomide 5 mg, 10 mg, 25 mg or 50 mg, when administered after azacitidine.

In phase 2, the objective was to assess the efficacy of MTD lenalidomide administered after azacitidine, in up to six 28-day cycles.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-29
• Study First Posted: 2009-04-30
• Primary Completion: 2011-06
• Study Completion: 2012-06
• Results First Submitted: 2014-10-13
• Results First Submitted QC: 2014-10-13
• Results First Posted: 2014-10-20
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Azacitidine followed by lenalidomide	Lenalidomide	Dose escalation then dose expansion
Azacitidine followed by lenalidomide	Azacitidine	Dose escalation then dose expansion

Primary Outcome Measures

Name	Time	Method
Compete Remission (CR) Rate	12 months	Compete Remission (CR) includes subjects with CR but incomplete recovery of blood counts (CRi). CR was assessed according to the European LeukemiaNet (ELN) guidelines, and is defined as the absence of clonal lymphocytes in the peripheral blood.

Secondary Outcome Measures

Name	Time	Method
Time to CR	18 weeks	CR includes subjects with CR but incomplete recovery of blood counts (CRi). Responses were assessed according to the ELN guidelines.
Maximum Tolerated Dose (MTD) of Lenalidomide	15 months	The maximum tolerated dose (MTD) of lenalidomide was determined in study phase 1, for use in study Phase 2 (not conducted). The outcome is reported as the dose of lenalidomide that represents the MTD.
Time to PR	36 weeks	Responses were assessed according to the ELN guidelines.
OS of Responders	88 weeks (median)	OS from the start of treatment of responders (per ELN guidelines) was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.
4-week Survival Rate	28 days	"Early death" was assessed as death within 28 days of the start of treatment
Remission Duration	26 months	Responses and remission were assessed according to the ELN guidelines.
Overall Response Rate (ORR)	26 months	ORR includes subjects with CR, CRi, and partial response (PR). Responses were assessed according to the ELN guidelines.
Overall Survival (OS)	88 weeks (median)	OS from the start of treatment was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States