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Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT) (ACROBAT)

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ClinicalTrials.gov Identifier: NCT04184505
Recruitment Status : Not yet recruiting
First Posted : December 3, 2019
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:
Open-label, randomized multicenter phase III non-inferiority study

Condition or disease Intervention/treatment Phase
High-risk MDS Drug: Azacitidine Drug: Standard Chemotherapy Procedure: Allogeneic stem cell transplantation Phase 3

Detailed Description:
Open-label, randomized, prospective multicenter phase III study to compare the role of HMT followed by HSCT vs HSCT upfront in HR-MDS with <10% of BM blasts and of CHT vs HMT followed by HSCT in HR-MDS with >10% BM blasts in terms of feasibility of HSCT (non-inferiority trial).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study on the Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-myelodysplastic Syndromes, Performed Upfront or Preceded by Azacitidine or Conventional Chemotherapy According to the BM-blast Proportion
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine

Arm Intervention/treatment
Active Comparator: Standard clinical treatment

If BM-blasts >= 10%: Conventional chemotherapy: induction one cycle (3+7 protocol) and one optional consolidation cycle, followed by HSCT if a suitable sibling or unrelated donor is available versus

If BM blasts are <10%: HSCT upfront

Drug: Standard Chemotherapy
  1. cycle (induction): i.v. 3+7 (Citarabine 200 mg/m2 iv continuous infusion (24 h) for 7 days, Daunorubicine 60 mg/mq iv day 1-3)
  2. cycle (consolidation): i.v. 3+7 (Citarabine 200 mg/m2 iv continuous infusion (24 h) for 7 days, Daunorubicine 45 mg/mq iv day 1-3)
Other Name: STD CHT

Procedure: Allogeneic stem cell transplantation
Allogeneic stem cell transplantation
Other Name: HSCT

Experimental: Experimental treatment

If BM-blasts >= 10%: Azacitidine (AZA) 75mg/sqm/day subcutaneously for 7 days every 28 days (1 cycle of 28 days) for at least 4 cycles, followed by HSCT if a suitable sibling or unrelated donor is available

If BM blasts are <10%: Azacitidine (AZA) 75mg/sqm/day subcutaneously for 7 days every 28 days (1 cycle of 28 days) for at least 4 cycles, followed by HSCT if a suitable sibling or unrelated donor is available

Drug: Azacitidine
75mg/mq/day subcutaneously for 7 days every 28 days
Other Name: AZA

Procedure: Allogeneic stem cell transplantation
Allogeneic stem cell transplantation
Other Name: HSCT




Primary Outcome Measures :
  1. Feasibility of HSCT in terms of proportion of patients who receive HSCT of the total number of randomized patients [ Time Frame: 4 years ]
    Split patients in two categories: the feasibility of HSCT (ITT) in patients with HR-MDS with a proportion of bone marrow blasts below 10% and in patients with a proportion of BM blasts equal or greater than 10%.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with newly diagnosed higher-risk MDS, including IPSS Intermediate-2 and high, and IPSS-R intermediate to very-high
  2. Age 18-70 years
  3. Previously untreated for HR-MDS
  4. HSCT - eligible
  5. Life expectancy ≥3 months;
  6. Signed written informed consent according to ICH/EU/GCP and national local laws
  7. Eastern Cooperative Oncology Group Performance Status Grade of 0-2

Exclusion Criteria:

  1. Acute myeloid leukaemia with >20% blasts in BM or peripheral blood (PB);
  2. concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma);
  3. severe renal, cardiac, liver or lung impairment;
  4. pregnant or lactating or potentially fertile (both males and females), who have not agreed to avoid pregnancy during the trial period; Women of childbearing potential and men must agree to use effective contraception during and up to 3 months after treatment with azacitidine.
  5. HIV infection; active, uncontrolled HCV or HBV infections or liver cirrhosis;
  6. clinically relevant neurological or psychiatric diseases;
  7. hypersensitivity (known or suspected) to AZA;
  8. prior Treatments:

    1. prior investigational drugs (within 30 days);
    2. radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions within the previous 6 months;
    3. growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days;
    4. androgenic hormones during the previous 14 days;
    5. prior transplantation or cytotoxic therapy, including azacitidine, AZA or chemotherapy, administered to treat MDS (a previous treatment with Lenalidomide is admitted, provided that lenalidomide had been stopped at least 60 days before enrolment).
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT04184505    
Other Study ID Numbers: MDS 0519
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
MDS
Transplant
Azacitidine
Additional relevant MeSH terms:
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Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors