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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02910752
• Other study ID #: Allo-HSCT-relapse-2015
• Status: Suspended
• Phase: Phase 1/Phase 2
• Start date: September 2016
• Est. completion date: September 2023

Study information

• Verified date: November 2021
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia

Intervention

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

Locations

Country	Name	City	State
China	Rui Jin Hospital, Department of Hematology	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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