NCT02910752

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 leukemia

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

7 years

First QC Date

September 7, 2016

Last Update Submit

November 23, 2021

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • chimerism (bone marrow)

    30 days after treatment

  • survival

    6 months

  • relapse (bone marrow)

    6 months

  • non-relapse mortality

    6 months

  • GVHD (clinical evaluation and grading)

    6 months

Study Arms (1)

CLAM|PBSC

EXPERIMENTAL

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

Drug: CLAM+PBSC

Interventions

CLAM+PBSCDRUG

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

Also known as: CLAMP
CLAM|PBSC

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with acute leukemia relapsed within 6 months after previous allo-HSCT
  • no active GVHD
  • mobilized PBSC from the original donor available

You may not qualify if:

  • ECOG \>=3
  • liver function/renal function damage (over 2 X upper normal range)
  • active infection including CMV and EBV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rui Jin Hospital, Department of Hematology

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jiong HU, M.D.,

    Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Blood and Marrow Transplantation Program, Chief Physician

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 22, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

November 26, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)