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

NCT ID: NCT02910752

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CLAM|PBSC

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

Group Type EXPERIMENTAL

CLAM+PBSC

Intervention Type DRUG

Cladribine 5mg/m2 + cytarabine 1.5g/m2 + mitoxantrone 10mg/m2 from D1 to D5

Interventions

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CLAM+PBSC

Cladribine 5mg/m2 + cytarabine 1.5g/m2 + mitoxantrone 10mg/m2 from D1 to D5

Intervention Type DRUG

Other Intervention Names

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CLAMP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jiong HU

Head, Blood and Marrow Transplantation Program, Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiong HU, M.D.,

Role: PRINCIPAL_INVESTIGATOR

Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Locations

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Rui Jin Hospital, Department of Hematology

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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Allo-HSCT-relapse-2015

Identifier Type: -

Identifier Source: org_study_id