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

Shanghai Jiao Tong University School of Medicine

Status and phase: Suspended; Phase 2; Phase 1

Conditions: Leukemia

Treatments: Drug: CLAM+PBSC

Study type: Interventional

Funder types: Other

Identifiers

NCT02910752

Allo-HSCT-relapse-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

CLAM|PBSC

Experimental group

Description:

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

Treatment:

Drug: CLAM+PBSC