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CLAM Chemotherapy With PBSC Support for Relapsed Patients After Allogeneic Stem Cell Transplantation

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Suspended
CT.gov ID
NCT02910752
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
84
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

For acute leukemia patients with early relapse after allogeneic stem cell transplantation, the overall outcome is poor. In this study, we evaluate the treatment outcome and safety of chemotherapy with Cladribine, cytarabine and mitoxantrone followed by peripheral stem cell support from the original donor.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

For acute leukemia patients experienced relapse 6 months or less after allogeneic stem cell transplantation, the overall outcome is poor. In this study, we design a treatment protocol aiming to achieve complete remission for this high-risk group of patients with chemotherapy consisting of Cladribine (5mg/m2), cytarabine (1.5g/m2) and mitoxantrone （10mg/m2）for 5 days followed by infusion of mobilized peripheral stem cell from the original donor. For patients who failed to achieved remission,a second cycles will be given. For patients who achieved remission, the post-remission therapy is open depend on patient's intent: consolidation with one more cycle, second allo-HSCT with different donor or continuous DLI.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Salavge Chemotherapy With Cladribine, Cytarabine and Mitoxantrone Followed by Mobilized Peripheral Stem Cell Infusion From the Original Donor for Relapsed Patients After Allogeneic Stem Cell Transplantation: Phase I/II Study
Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: CLAM|PBSC

CLAM chemotherapy with mobilized PBSC infusion: Cladribine 5mg/m2 + cytarabine 1.5g/m2 + mitoxantrone 10mg/m2 from D1 to D5

Drug: CLAM+PBSC
Cladribine 5mg/m2 + cytarabine 1.5g/m2 + mitoxantrone 10mg/m2 from D1 to D5
Other Names:
  • CLAMP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. complete remission (Bone marrow) [30 days after treatment]

      bone marrow aspiration performed on D30 after treatment. In case of less 5% blast with fully recovery of peripheral blood count is considered as CR. In case of less than 5% blast without fully recovered CBC is considered as CRi

    Secondary Outcome Measures

    1. chimerism (bone marrow) [30 days after treatment]

      chiremism analysis of patients bone marrow mononucleared cells at day 30 after treatment

    2. survival [6 months]

      patients remain alive 6 months after enrollment

    3. relapse (bone marrow) [6 months]

      bone marrow relapse within 6 months after treatment

    4. non-relapse mortality [6 months]

      patients died due to any treatment complication or other cause except for disease progression or relapse

    5. GVHD (clinical evaluation and grading) [6 months]

      grade II-IV acute GVHD and cGVHD if presented

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients with acute leukemia relapsed within 6 months after previous allo-HSCT

    • no active GVHD

    • mobilized PBSC from the original donor available

    Exclusion Criteria:

    • ECOG >=3

    • liver function/renal function damage (over 2 X upper normal range)

    • active infection including CMV and EBV

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rui Jin Hospital, Department of Hematology Shanghai China 200025

    Sponsors and Collaborators

    • Shanghai Jiao Tong University School of Medicine

    Investigators

    • Principal Investigator: Jiong HU, M.D.,, Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiong HU, Head, Blood and Marrow Transplantation Program, Chief Physician, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02910752
    Other Study ID Numbers:
    • Allo-HSCT-relapse-2015
    First Posted:
    Sep 22, 2016
    Last Update Posted:
    Nov 26, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Nov 26, 2021