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

Phase 1

Suspended

• Conditions: Leukemia
• Interventions: Drug: CLAM+PBSC

• Registration Number: NCT02910752
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-22
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-26
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
survival	6 months	patients remain alive 6 months after enrollment
GVHD (clinical evaluation and grading)	6 months	grade II-IV acute GVHD and cGVHD if presented
chimerism (bone marrow)	30 days after treatment	chiremism analysis of patients bone marrow mononucleared cells at day 30 after treatment
relapse (bone marrow)	6 months	bone marrow relapse within 6 months after treatment
non-relapse mortality	6 months	patients died due to any treatment complication or other cause except for disease progression or relapse

Trial Locations

Locations (1)

Rui Jin Hospital, Department of Hematology; 🇨🇳 Shanghai, China