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AZALENA 2013

AcronymISRCTNEudraCTClinicaltrials.govDRKS
RV-MDS-PI-07772013-001153-27

Phase-II trial to assess the efficacy and safety of Lenalidomide in addition to 5-Azacitidine and donor lymphocyte infusions (DLI) for the treatment of patients with MDS, CMML or AML who relapse after allogeneic stem cell transplantation.

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

To evaluate the safety and feasibility of the addition of Lenalidomide to the standard therapy of Azacitidine and DLI as first salvage therapy for relapse after allo-SCT

Secondary Outcomes

To assess the efficacy of the combination of Lenalidomide, Azacitidine and DLI as first salvage therapy for relapse after allo-SCT

Diagnosis

First relapse after first allgeneic SCT for MDS, CMML or AML

Patient attributes

Age

18-99

Inclusion criteria

  • First relapse of de novo or therapy-related MDS, CMML or AML with myelodysplasia-related changes and 20-30% bone marrow-blast (formerly RAEB-T) according to WHO 2008 classification after first allo-SCT (related or unrelated donor with < 2HLA mismatches)
  • Possibility of DLI (no cord blood, no haploidentical donor)
  • no previous therapy for relapse after allo-SCT
  • ECOG performance status ≤ 2 at study entry (s. Appendix)
  • no active GvHD treated with systemic immunosuppression within 4 weeks before inclusion
  • no uncontrolled infection at inclusion
  • Understand and voluntarily sign an informed consent form.
  • Age: 18 years or older.

Exclusion criteria

  • Relapse after second allogeneic transplantation
  • Any previous therapy (chemotherapy, radiation or investigational drugs) administered as therapy for relapse after allo-SCT
  • previous transplantation with cord blood, an haploidentical donor or a related/unrelated donor with ≥2 HLA mismatches
  • Active GvHD requiring systemic immunosuppression
  • Uncontrolled infection
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or lactating females
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • Impaired renal function (GFR < 20 ml/min)
  • Impaired hepatic function, as follows: Aspartate aminotransferase (AST) ≥3 x ULN, Alanine aminotransferase (ALT) ≥3 x ULN, Total bilirubin ≥3 x ULN, Alkaline Phosphatase ≥3 x ULN
  • Known hypersensitivity to thalidomide, lenalidomide or any components of the treatment
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Concurrent use of other anti-cancer agents or treatments.
  • Known positive for HIV or infectious hepatitis, type A, B or C.
  • Neuropathy ≥ grade 2
  • Prior history of malignancy other than MDS or AML (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ≥ 3 years.

Trial design

  • Phase II
  • Multicenter
  • Prospective
  • One-arm
  • Open Label

Intervention

  1. 5-Azacytidine 75mg/m2/d für 7 days for 8 cycles
  2. DLI after cycle 4 (dose 0,5-1x10E6 CD3/kg), cycle 6 (dose 1-5x10E6 CD3/kg), cycle 8 (dose 5-15x10E6 CD3/kg)
  3. Lenalidomid for 21 days for 8 cycles

Miscellaneous

Dose of Lenalidomide:

first 10 patients of the trial = 2,5mg/d

then interim safety analysis = if no dose limiting toxicity:

next 10 patients of the trial = 5mg/d

Documents (password protected)

Responsibilities in overall trial

Heinrich-Heine Universität Düsseldorf

  • Tel. +49 (0)211 81-00

National Coordinating Investigator

PD Dr. med. Guido Kobbe

Study Sites

Klinik I für Innere Medizin

Status

Active (Recruitment Closed)

Principal Investigator

Prof. Dr. med. Dr. h. c. Christoph Scheid

Deputy of Principal Investigator

  • PD Dr. Dr. med. Udo Holtick
  • PD Dr. med. Marco Herling

Subinvestigator

  • Dr. med. Carmen Diana Herling
  • Dr. med. Lukas Frenzel

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